10
Mar

Top News Websites For Clinical Trials Professionals

Olivier Roth is a digital marketing strategist and former Marketing Manager at ClinCapture. In 2014, Olivier launched Timelapse to create a new space for marketers and entrepreneurs to meet and learn from experienced peers. Timelapse also provides digital marketing consulting services to local biotech companies and start-ups. Prior to Timelapse, Olivier was Marketing Manager at Clinovo. Prior to ClinCapture, Olivier was working as a Strategic Marketing & Innovation Consultant at VivaSante, an international consumer healthcare company based in Paris.

The team at ClinCapture is always interested in reading clinical trials news as well as news related to eClinical systems. We’ve actually just put together a report on the top eClinical trends detailing the biggest changes and shifts in the eClinical system landscape in recent years.

We wanted to list our favorite news, trends, and data sources in the clinical trial space. We hope you’ll take advantage of this list. Please feel to comment and submit more websites!

  • Applied Clinical Trials: Applied Clinical Trials is a global, peer-reviewed journal and website for the global clinical trial community that designs, initiates, manages, conducts, and monitors clinical trials. Most articles on their website are peer-reviewed and always of excellent quality. Definitely a reference for clinical trial professionals.
  • Pharma Voice: Also a trusted source of news in the industry, Pharma Voice is written and edited by some of the industry’s most knowledgeable journalists. They’re very present and invested at conferences and community events and deliver complete coverage on every aspect of pharmaceutical business from molecule to market: clinical development, commercialization, regulation, technology, and much more.
  • CenterWatch: Combining a news website, a journal and a clinical trial directory, CenterWatch is the ‘swiss army knife’ of the drug development industry. The list of recruiting clinical trials, the latest FDA approved drugs and the industry providers profile are very useful to drug developers and clinical trial professionals.
  • FiercebiotechIT: Part of a series of news websites owned by FierceMarkets, FiercebiotechIT is one of the only website focused on eClinical systems, big data, and eClinical Cloud. It is particularly relevant to us as the provider of cloud-based eClinical system ClinCapture. Noneless, it is one the largest website as far as web traffic and readership.
  • Clinical Leader: The subscription-based website Clinical Leader offers interesting and relevant viewpoints, interviews and editorial articles. It is a great place to understand long-term trends and read well-written, relevant high quality content.
  • SCDM: The Society for Clinical Data Management (SCDM) offers a large annual conference for clinical data managers, as well as local chapters and learning opportunities. Their monthly newsletter, Data Basics, is perfect for data management professionals in the clinical trial industry to stay up to date with qualified, often peer-reviewed articles and papers.
  • Biospace: It is one of the largest news and career website in the clinical trial industry. Biospace is undoubtedly a reference for the extend of its news and content nation- and world-wide. It is particularly useful to read a snapshot of breaking news about large or mid-sized pharma companies. Biospace also organizes quality networking events and career fairs.

By Olivier Roth, Digital Marketing Strategist at TimelapseSF.com

29
Jan

Millennials in Research: New Ideas to Think, and Run Your Studies

Guest blog from prcclinical.com

T.-Taricco - PRC - ClinovoTony Taricco co-founded PRC Clinical in 2003. As the President and board member, he is responsible for the general business operations and finance activities, as well as human resources, and clinical payment services.Tony spent 20 years in Workers Compensation Insurance, starting as a Claims Adjustor for a small company of 25 employees and growing with that company to the position of Vice President and a staff of nearly 300. Tony’s business degree and extensive practical experience in business growth brings together the unique perspective of understanding the values and challenges of a small business and molding those into a strong foundation for long term expansion.

Recruiting for clinical trials is notoriously difficult and social media sites like Facebook and Twitter are being used to even out the odds. But it took a 21-year-old worker to come up with the idea of pitching a trial on Snapchat. The clinic signed up a participant the same day. “That was an eye-opener for me,” said Dan Sfera, a consultant to research clinics. He wouldn’t have thought of Snapchat, an app favored by teens and 20-somethings. Sfera is only 34.

FUTURE LEADERS

The story is just one example of how millennials, the generation born roughly between 1980 and 2001, are making their mark on clinical trials. As digital natives at ease with social media, they are helping companies find faster, less expensive and better ways of operating.

Already the majority of the staff coordinating and handling day-to-day tasks involved in clinical trials are millennials,according to James Denmark, founder and CEO of myClin Clinical Research.[1] They might be handling operations entirely at some small sites.

“If you fast-forward about five years, you’re going to find that almost all of the field research is being performed by the millennials,” Denmark said during a video conference to discuss the report, “I’m the Millennial That Is Running Your Clinical Trial.”[2]

Another 10 years and they will dominate the entire ecosystem, Denmark said,[3] estimating that millennials already represent 73 percent of the clinical trial-related workforce.

The percentage may not be surprising given that more than one-in-three U.S. workers today is a millennial. But it may be more surprising that this year millennials surpassed Generation X (the age group that most of upper management in the clinical trial industry fit into) to become the largest share of the country’s workforce, according toPew Research Center analysis of U.S. Census Bureau data.[4]

DIGITAL NOMADS

Predictions are always tricky but ignoring them risks eliminating a major pool of employees and tomorrow’s VPs. Millennials — those running clinical trials as well as those participating in them — are having an effect on the industry that reaches into their structure. Clinical trials are marked by a series of complex, rigidly defined steps and regulations. In contrast, the millennial generation has been raised on the legends of tech startup founders who became billionaires largely on their own terms. The result is a generation with a low tolerance for unfriendly processes and systems.

They believe clinical trials should be centered around what matters to patients rather than solely what is of interest to the people behind the studies. They also tend to be uncomfortable with rigid corporate structures and reject information silos. And they have a reputation for being self-starters. But they expect constant feedback as they try to advance quickly up the corporate ladder during a varied and interesting career at multiple companies.

Technology is helping to drive these expectations. Millennials are the country’s first “digital natives.”[5] In other words, they are the only generation so far which has not had to adapt to new technologies. Being digital natives means millennials are used to getting the information they want when they want it and from a multitude of sources such as social networks, rating websites and word of mouth referrals, according to MD Connect, a digital medical marketing agency. “The first thing a millennial does is Google something,” Jonathan Catley, MD Connect’s sales and marketing director, said.

They have grown up with broadband, smartphones, laptops and social media being the norm and expect instant access to information, according to an online survey of 4,364 new college graduates by PricewaterhouseCoopers.[6]“The millennial generation’s world is digital and this has an inevitable effect on the way they communicate,” according to the report, “Millennials at work: Reshaping the Workplace.”[7]

That means communicating online or video conferencing rather than face-to-face or over the telephone. Email still has a place but “absolutely forget about faxes,” Denmark said. Instead, millennials expect[8] to be mobile, working with their smartphone from home, the office or cafes.

Millennials say[9] they routinely make use of apps running on their own smartphones, tablets and laptops while they are on the job. They often work outside of normal business hours, with about a fifth of them identifying as “night owls.” In other words, as the PricewaterhouseCoopers report put it, “millennials want a management style and corporate culture that is markedly different from anything that has gone before – one that meets their needs.”

Being a wired nomad may not as feasible for clinical trial workers as their peers in other industries because of concerns about compromising patient privacy by using insecure mobile technology. Indeed, encryption will be an issue that companies have to tackle as employees regardless of age and industry increasingly use their own devices filled by an array of apps.

TAMING THE PAPER STORM

Of course, changes are not easy, but John Silowsky, the clinical operations chief Bay Area-based Nektar Therapeutics, said the effort paid off when the company launched a Phase III program of a compound designed to treat chronic pain.

He knew he had a young staff that wouldn’t put up with the slow, top-down approach of most trials. So he decided the company was going to go in a new direction by “tearing down the walls” between Nektar and the vendors and sites involved in the program.  Silowsky brought in research sites and investigators early on, even before the protocol was developed “to make this journey” as a team.

“We were going rough and raw and putting out our work out there in the public space and making it available for review and comment,” he said. “It was scary.” But they tamed the paper storm and made the process more efficient and concise. It “took us to another level of collaboration,” Silowsky said. “We’re only a click away from our investigators our site staff and more importantly from our patients”.

By Tony Taricco, Co-Founder and COO at PRC Clinical

[1] http://xtalks.com/downloads/15q058.pdf

[2] http://xtalks.com/thankyou-15q058myclin.ashx

[3] http://xtalks.com/thankyou-15q058myclin.ashx

[4] http://www.pewresearch.org/fact-tank/2015/05/11/millennials-surpass-gen-xers-as-the-largest-generation-in-u-s-labor-force/

[5] http://www.mdconnectinc.com/about-md-connect/medical-marketing-insights/bid/77788/healthcare-marketing-and-the-millennials

[6] https://www.pwc.com/m1/en/services/consulting/documents/millennials-at-work.pdf

[7] https://www.pwc.com/m1/en/services/consulting/documents/millennials-at-work.pdf

[8] http://www.halogensoftware.com/blog/generation-y-understanding-the-work-habits-of-millennials

[9] https://www.pwc.com/m1/en/services/consulting/documents/millennials-at-work.pdf

28
Dec

Top eClinical Trends of 2015

Clinical research is well on its way to transforming its paper-driven model to an all things electronic format. During the past year, the clinical trial industry has made considerable progress in adopting technology as a way to streamline data collection, transmission, and monitoring.

Among the latest developments- adoption rates are higher for EDC, eSource, and eClinical integration, as the focus is now on capturing real-time data as a continuous stream. These trends are partially the result of high-tech devices, sensors and wearables entering the clinical trial industry, as well as the FDA embracing technology and opening up a dialogue with experts on how to best channel this revolution in order to advance clinical research. Here is a closer look at the most recent trends.

Higher EDC Adoption

smart doctorThe move to conduct clinical trials from paper to Electronic Data Capture (EDC) has accelerated over the past 10 years in an overall effort to increase data quality, regulatory compliance and to reduce cost. This trend has grown because of the need to share real-time data and facilitate strategic decisions to be made during the study based on its progress.

According to a newly released report, the healthcare cloud computing market is expected to grow from $3.73 billion in 2015 to $9.48 billion in 2020. The eClinical solutions market, including cloud-based solutions, is projected to grow 14% by 2020, reaching an estimated $6.52 billion, up from $3 billion in 2014.

Different sources of data present many data management challenges, which is why cloud solutions are quickly gaining popularity. Cloud-based technology brings efficiency and cost-effectiveness in managing clinical data, and works for both pharma companies and their CROs. Utilizing cloud infrastructure scales and streamlines data, improving its quality and allowing for a simple, seamless experience.

According to a recent report by the Industry Standard Research (ISR), in 2013 two providers accounted for more than 50% of EDC service. This year, five EDC providers accounted for over 50% of the market share, which shows that the market for these services is growing. The same report also shows that EDC has become standard practice with approximately 88% of Phase 3 clinical trials initiating use of the technology.

However, as recent Clinical Ink research points out, volumes of paper still delay clinical trials due to reliance on 100% source document verification (SDV). Risk-based monitoring (RBM) is also advancing at a high pace while sponsors and study teams don’t have the right eClinical solutions to generate real-time data. This explains the emergence of the next trend on our list- electronic source documentation (eSource).

 

esource eSource on the Rise

Two years ago, in an effort to move away from paper inefficiencies, the U.S. Food and Drug Administration (FDA) issued its final guidance on Electronic Source Data in Clinical Investigations. In this guidance, the agency promotes capturing source data in electronic form to assist in ensuring the reliability, quality, integrity and traceability of data from electronic source to electronic regulatory submission.

According to the Food and Drug Administration (FDA) eSource Guidance of 2013: “Electronic source data are data initially recorded in electronic format. They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation”. In other words, this is data that is entered directly into a digital format without having to first record it on paper and then transfer it to an electronic data capture solution.

Investigators like the flexibility and versatility of pen and paper, and they perceive computerized systems as a drain on their productivity. The Internet is not always easily accessible from the clinical sites, especially overseas. This is why new eSource solutions are built on tablets that can address these two hurdles. Tablet applications are designed to “look and feel” just like paper, but they offer the efficiency of an electronic document. Unlike case report forms (CRFs), which only capture the data necessary for analysis, eSource documents encompass the much broader goal of providing affirmative documentary evidence related to a subject case history and site audit, and allow for random, ad-hoc comments.

Other benefits of eSource documents include increase in clinical data quality through validation checks and the removal of unnecessary duplication of data, as well as the reduction of monitor site visits by eliminating source document verification (SDV) and enabling remote document review. However, despite the many benefits, esourced documents can still be challenged from a GCP compliance perspective.

One way for e-source solutions to comply with regulations and guidelines is to make the first data recording on paper or keep the source data in the clinical investigator’s control by entering it in a medical record or a medical record system. The FDA doesn’t regulate EMR, therefore it is not subject to 21 CFR Part 11 requirements. Collected data can be entered into eCRFs directly on the condition that it meets all regulations. If the clinical data is transferred to an eCRF from an EMR, then that EMR is considered the source. The FDA has made it clear that clinical trial monitors and auditors should have access to verify the data in the EMR.

Electronically collected data can be kept on or off-site. On-site storage can present many logistics challenges such as data corruption or loss, SOPs, software validation plan, restricted access and many others. Data not store locally should be under the control of the investigator in order for it to be compliant. Thin-client architecture, which delivers e-sourced data straight into the CRO’s remote server, can sometimes also be GCP non-compliant.

The FDA has made substantial efforts in supporting the use of electronic data solutions in the past couple of years. Among the many benefits, eSourcing helps control fraud as it is far more difficult to fabricate electronic records compared to paper ones.

 

eTMFRecord Adoption of eTMF

A 2015 report by Cutting Edge Information shows that adoption of eTMF is expected to reach 88% by 2020. Currently, only about 54% of TMF is electronic-based. The report also indicates that updating paper documents to an electronic platform is more time-consuming than building new TMFs in an electronic system. To overcome the challenges associated with eTMF platforms, many surveyed teams reported executing eTMF strategies in waves. For example, teams may start by building new TMFs into an electronic system as part of a paperless pilot program, before updating paper documents from older studies.

Another recent study done by an eTMF provider also claims a drastic spike in eTMF adoption this year. The Veeva 2015 Paperless TMF Study (Veeva is the provider of Vault eTMF) surveyed 50 international CROs and found that 38% use electronic trial master file (eTMF) applications in comparison to 21% just one year ago—a sudden, 17 percentage point increase, striking especially for a market that traditionally moves more gradually. The same report also claims that, as compared to 2014, greater numbers of CROs now exchange TMF documents with sponsors via eTMF applications (36% today, up from 24%), and are much less reliant on paper (46%, down from 65%).

 

RBMChanges in RBM Trends

Recent trends in RBM were discussed at the November 2015 CBI Conference on risk based trial management. Among the topics were the changing roles of study monitors, as well as the way RBM is changing how clinical trials are conducted. Even though some CRO and sponsors aim for 100% SDV, the path to RBM has been forged with many new technology companies addressing RBM in the last couple of years.

Recent trends indicate that sponsors are comfortable outsourcing source data verification and monitoring visits to CROs but they prefer to insource Clin Ops and data management so they can have more real-time control over the study, and mitigate any fallouts as they happen.

The FDA recently developed a risk-based site selection tool which collects NDAs by clinical investigator sites and allows the agency to use the stratified data in order to select site for GCP inspections.

Experts point out that as more companies are executing RBM, clinical trial teams should differentiate between the critical endpoints of study protocol and monitoring setup, and the clinical data that will reflect the critical safety and efficacy endpoint. The value of RBM would not be leveraged if all data would otherwise be treated equally instead of being classified.

Another useful piece of advice is to pay attention to data trails and the changes made, having 100% QC of any modifications. The recent trend in higher RBM adoption has adapted the monitoring role to keep track of any changes the study team and sites are making. Experts say that is the way for people, processes and technology to complement each other when using RBM in a clinical trial.

 

econsent eConsent Adoption

The FDA defines electronic consent as “using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive web sites, biological recognition devices, and card readers) to convey 30 information related to the study and to obtain and document informed consent”.

There are several eSignature and eConsent systems currently available on the market. In addition, companies such as Apple are also entering the medical research market with apps and wearable technology. For example, Apple’s ResearchKit has a module for building electronic consent forms.

A recent survey of the top 50 pharma companies shows that about 66% of them are either using eConsent or planning to in the near future. The percentile is even higher among the top 25 companies on the list- 88% of them have implemented eConsent. 100% of the top ten companies have also put eConsent initiatives in place.

 

 

ePRO ePRO to Replace Paper Soon

Technology is also placing the patient at the epicenter of clinical research. Fast-developing ePRO technologies allow patients to report clinical data themselves. The modern ePRO systems are designed to maximize the ease in which patients report their observations. Additionally, they better integrate with eClinical systems to capture and spread relevant clinical data faster to clinical teams. For example, ePRO systems integrate with electronic data capture (EDC) systems to automatically and securely import clinical data from the ePRO directly into the EDC system. This allows a quicker response time in the case of adverse events for example.

In a recent survey, examining 22 sponsors and CROs, 18 reported having adopted ePRO which resulted in increased data quality, patient compliance and efficient data collection. 61% of the surveyed companies indicated they implemented ePRO in the last five years, 28% in the last 10 years, and 11% over 10 years ago. Experts say the increased emphasis placed on patient reported outcomes and the push for technology adoption in clinical trials has resulted in significant increase in ePRO use. The Tufts survey also points out there’s been an overwhelming increase in ePRO usage in the oncology field. The main drawback has been the cost of using ePRO compared to paper.

However, the higher ePRO adoption trend is likely to continue as more companies see its value for post-marketing trials, as well as its benefits and capabilities expanding as more vendors enter the space each year.

 

integration1eClinical Integration

With increased regulatory requirements and the trend towards personalized medicine, sponsor companies and CROs need to access more specific solutions to meet their need, making systems integration an increasing necessity for a successful clinical trial. In addition, risk management of the product’s life cycle includes investigators, regulators and patients. This is where systems integration comes in; ensuring data is more accurate and consistent.

Leveraging technology to optimize speed, quality and cost of clinical trials is a big hurdle for pharma and their CRO partners. Bringing drugs and medical devices to market faster is most important for business success. CROs are quickly realizing that in order to remain competitive, they need the IT infrastructure to accommodate an influx of clinical data that would be well-organized and easily accessible from a central data warehouse.

This warehouse should handle the integration, reporting, management, visualization and analysis of all clinical data. For example, an integrated system, comprised of custom CTMS, Pharmacovigilance, EDC and a CDISC-compliant data warehouse enables the timely analysis of clinical data. Traditional integration between electronic data capture (EDC), clinical trial management systems (CTMS), clinical data repositories (CDR), clinical data management systems (CDMS) and statistical analysis systems (SAS) may require a lot of manual data sharing. While many sponsors can afford to transcribe data in the right format before sending it to their CROs, smaller companies still struggle to prepare their data for FDA submission.

That is why integration is crucial for both clinical trial sponsors and CROs to exchange data during all trial phases. Big pharma reportedly spends close to $200 million annually for data transfer. But new trends are emerging to combat the old ways of not transferring data until all collection is done. More and more trials are now conducted with the data moving in the early phases. This method allows managers to spot and ferret out potential problems, thus saving money and time. Another trend which saves time and money is following the CDISC’s (Clinical Data Interchange Standards Consortium) CDASH (Clinical Data Acquisition Standards Harmonization) data submission fields. This saves companies from not having to restructure their data in the drug-approval process. CROs must also follow data aggregation formats such as STDM (Standard Data tabulation Model).

Whether you choose EDC & CTMS, eTMF & Safety, or EMR integration, there is no one-stop-shop solution. For example, CTMS solutions such as Advanced Clinical Software’s Study Manager have been installed at over 2,000 sites but there are still no defined metadata and communication standards that allow CTMS and EDC solutions to share data. A common issue with EDC-CTMS integration occurs when there are complex investigative site business practices. Most EDC systems only capture clinical trial data through eCRFs that lack CTMS information. Another issue is that some EDCs may lack timeline planning features such as reaching target subject recruitment milestones, for instance. As for eTMF & Safety integration, common issue here is the lack of real-time inspection and ICH/GCP compliance.

One way for improving this process is to focus on data analysis, not just warehousing it. Most companies only focus on front-end integration without considering the need to generate reports for regulators later. If data were integrated from the start, it would be easily accessible at any point. However, this is easier said than done, as implementing systems integration is estimated to cost about $500K and take as much as 3-6 months, which can come up to nearly 10% of the research budget.

Collaboration and consolidation among front-end and back-end systems, as well as the emergence of advanced eClinical systems or modules, shows that the value of integrating will only continue to grow as users see the efficiency in storing and viewing their data on a single interface.

 

cdisc_titles2 CDISC Standards Mandate Affecting U.S. and Japanese Submissions

Last December the FDA published a landmark package of Guidances, specifications and other documents governing electronic submissions. These have the force of law, which in effect made the use of CDISC standards mandatory in the United States and Japan by December, 2016.

The FDA Guidances establish the framework for the requirement of standardized study data in submissions, and cover most aspects of submission data and documentation.

The new mandate adds on pressure for CROs and sponsors to conform. In addition, the FDA is also considering updating the CDASH standards, which would also have a significant impact on current clinical trial processes.

 

Medicine doctor hands holding capsule medicineClinical Trial Paradigm Shift

A paradigm shift is taking place in the oncology clinical trial space, partially as a result of the Obama Administration launching its “Precision Medicine Initiative” earlier this year. Precision medicine is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles.

According to a White House release, a $215 million investment in the President’s 2016 Budget will be allocated to the Precision Medicine Initiative to pioneer this patient-powered research and provide clinicians with new tools, knowledge and therapies to select the treatments that work best for their patients.

The funding will be spread out between the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC) [15].

According to the White House, the objective for the National Cancer Institute is to accelerate the design and testing of tailored treatments for cancer by expanding genetically based clinical cancer trials. In June of this year, the NCI announced the launch of its nationwide clinical trial, utilizing DNA sequencing. In other words, subjects are grouped based on similarity in their genetic mutations, not the location of their cancer. The grouping is also known as “basket trials”. In the study, a few thousand patients at 2,400 sites throughout the United States will be sorted out into over a dozen treatments based on their tumor’s mutation.

The American Society of Clinical Oncology also recently announced the launch of a project that will provide patients with drugs targeting similar molecular abnormalities, and collect the data from their oncologists in order to monitor the effectiveness of the treatments.

The National Institutes of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of over a million Americans who volunteer to participate in research.

The trial subjects will be involved in the design of the Initiative and will have the opportunity to contribute various data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.

The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its critical privacy and participant protection framework.  As part of this effort, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome.

 

 

 

 

 

 

 

2
Dec

DNA sequencing is changing the oncology clinical trial space

dna A paradigm shift is taking place in the oncology clinical trial space, partially as a result of the Obama Administration launching its “Precision Medicine Initiative” earlier this year. Precision medicine is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles.

According to a White House release, a $215 million investment in the President’s 2016 Budget will be allocated to the Precision Medicine Initiative to pioneer this research and provide clinicians with new tools, knowledge and therapies to select the treatments that work best for their patients. The funding will be spread out between the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC).

The objective for the National Cancer Institute is to accelerate the design and testing of tailored treatments for cancer by expanding genetically based clinical cancer trials. In June of this year, the NCI announced the launch of its nationwide clinical trial, utilizing DNA sequencing. In other words, subjects are grouped based on similarity in their genetic mutations, not the location of their cancer. The grouping is also known as “basket trials”. In the study, a few thousand patients at 2,400 sites throughout the United States will be sorted out into over a dozen treatments based on their tumor’s mutation.

The American Society of Clinical Oncology also recently announced the launch of a project that will provide patients with drugs targeting similar molecular abnormalities, and collect the data from their oncologists in order to monitor the effectiveness of the treatments.

The National Institutes of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of over a million Americans who volunteer to participate in research. The trial subjects will be involved in the design of the Initiative and will have the opportunity to contribute various data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.

The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its privacy protection framework. As part of this effort, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome.

16
Nov

3D printed pills may soon find their way into consumer medicine cabinets

The FDA approved the first 3D printed pill back in August this year and the manufacturer, Aprecia Pharmaceuticals, is currently working on three additional products in its pipeline. Mainstream 3D prinitng can have a significant impact on big pharma’s business model, changing the economies of scale to cost-efficient drug production.

The Ohio based company is the first in the world to use 3D printing for the development and manufacturing of prescription drugs. Spritam, the 3D printed pill the FDA approved, is prescribed to adults and children with epilepsy for the treatment of sudden on-set seizures. This is the same anti-epileptic drug as Levetiracetam or Keppra. It utilizes a proprietary ZipDose® Technology that uses three-dimensional printing to produce a porous formulation which disintegrates rapidly with a sip of liquid. The company developed its platform from 3D printing technology that originated at the Massachusetts Institute of Technology (M.I.T.).

The company is targeting highly prescribed, high-dose products in order to capture a sizable share of the market. Right now, the rest of the drug makers use a standard size dose and patients often have to split pills for the right dosage. Aprecia’s 3D printing technology allows for layers of the medication to be packaged better and in more precise doses.

Bio printing has a lot of promise to revolutionize medicine as we know it. It has already had some recent success. Last year, for example, CNN reported that a two-year-old girl in Illinois, born without a trachea, received a windpipe built with her own stem cells.

The U.S. government has also funded a university-led research project which prints tissue samples designed to mimic the functions of the heart, liver, lungs, and other organs. The samples are placed on a microchip and connected with a blood substitute to keep the cells alive, thus allowing doctors to test specific treatments and monitor their effectiveness.

Spritam is the most high-impact breakthrough yet. According to its manufacturer, there are close to three million epilepsy patients in the United States, with approximately 460,000 of those cases occurring in children. Children and older patients who report difficulty swallowing can benefit from this new fast-melt technology the most.

aprecia-zipdose
9
Nov

New EU IVD and medical device regulations to be adopted in 2016

fdaupdatesEuropean union officials are planning to impose stricter regulations on all companies in the medical devices field, thus changing Europe’s reputation as a destination with favorable regulatory policies.

The revisions are expected to be adopted in the first half of 2016 and implemented in 2019, and would affect existent medical device and in vitro diagnostic device regulations.

According to a report from BSI Group, both medical device categories would be subject to a new supply chain structure, as well as a new risk classification system, and tougher testing and certification standards.

Also among the proposed changes is the addition of cosmetic implants, contact lenses and invasive laser equipment to the regulated med devices list.

BSI Group points out that in the in vitro diagnostic space, the number of devices requiring a notified body certification would go up to almost 90% compared to only about 20% now.

In addition, the new provisions prohibit grandfathering of medical devices already on the market so all new and existent products must comply within a given timeline once the new regulations are written into law.

Coming up next, Clinovo will feature a short blog series discussing the impact of these new regulations on medical device companies with advice from a Q&A expert on ensuring compliance.

The U.S. might be next on the list to update its current drug and medical device approval process. Right now, it takes between 12 and 15 years to get from discovery to market. According to Wireless-Life Sciences Alliance (WLSA), five out of 5,000 drug compounds make it to human testing and only one out of these five is approved to be sold on the market. In other words, the process has not kept up to speed with advances in technology, medical knowledge and patient behavior.

The WLSA has proposed a redesigned approval process pictured in the info graphic below, including suggested improvements to the regulation of drugs, medical devices and health IT.

New Infographic

2
Nov

Global Clinical Research Market to Reach $60 Billion in 2020

Scientist looking through microscopeAccording to a newly released report by Zion Research, the global contract research market is expected to reach $59.42 billion in 2020. Last year’s market valuation was $34 billion. This accounts for a 10% compounded annual growth rate.
The demand for outsourcing clinical development to contract research organizations (CROs) has been rising steadily as a result of high in-house R&D cost as well as the high failure rate of clinical trials.
Another growing trend has been a rise in strategic alliances, joint ventures and acquisitions among vendors in the CRO market with the goal of expanding service offerings and global reach.
 
The report divides the CRO market into Americas, EMEA (Europe, Middle East and Africa) and APAC (Asia Pacific) regions with the US CRO market dominating half of the world market share in 2014. However, Asian, Latin American and Eastern European countries are popular research destinations as they provide access to large, low-cost patient populations as well as low-cost manufacturing and skilled clinical workforce.

According to the report, last-stage clinical development sector was the largest employer in the CRO market with more than 70% of the 2014 total market share. This includes phase phase II-IV clinical studies and central lab services. This sector is projected to have the fastest growth in the next five years.

Some of the major stakeholders in the CRO market are global contract research organizations such as Quintiles, Covance, Parexel, PRA International, Charles River Laboratories, Accenture and Cognizant.

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26
Oct

CROs and clinical research jobs can benefit from R&D tax credit

Tax reform has become an important issue in the 2016 U.S. presidential election. The U.S. Congress has also entertained the issue for a while. As a result, the Association for Clinical Research Organizations (ACRO) has focused on changes to the Research & Development tax credit that would help CROs and level the playing field between the U.S. and other countries. It has expressed its support of the COMPETE Act which, if passed, would expand the R&D tax credit to contract research organizations.

Right now, when a sponsor outsources clinical trial research and development, they can claim up to 65% of the eligible R&D expenses in tax credit. In the scenario of the research being conducted in house, they can claim 100%.

On the contrary, in Canada, the UK, Austria and France, CROs are eligible to claim the entire amount for the R&D credit because they are in fact the employers of all research staff. That is why ACRO is raising the point that while the U.S. will continue to be a hub for clinical research, a tax reform would help keep the U.S. competitive and encourage higher paid research jobs in the States.

Contract research organizations contribute to innovative medical product development and according to the sixth biennial Battelle and BIO report, research has been the fastest growing biotech sector.

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19
Oct

Silicon Valley BioTalks “eClinical Systems Integration” Takeaways


BioTalks
Clinovo recently hosted the 11th BioTalks on the topic of clinical systems integration at the HP Headquarters in Palo Alto. The panel featured clinical industry experts Carey Smoak (Portola Pharmaceuticals), Lin Wan (Stella Technologies) and Hajime Arnold (Wincere), and was moderated by Clinovo CTO Marc Desgrousilliers. The speakers shared their experience and views around challenges and best practices as well as the recent trends in the field.

One of the important takeaways was that not all systems integration is equal. For example, according to Hajime Arnold, there is much more value in clinical and safety data integration compared to CTMS and EDC due to the fact that safety data reconciliation can be a very costly and error-prone process which affects FDA submission, and can thus be streamlined with the right integrated solution.

Whether a company should integrate or handle using multiple systems depends on its maturity and internal processes in place. However, panelists pointed out that collaboration and consolidation among front-end and back-end systems, as well as the emergence of advanced eClinical systems, shows that the value of integrating is growing as users see the efficiency in storing and accessing data on a single interface.

With increased regulatory requirements and the trend towards personalized medicine, sponsor companies and CROs need to access more specific solutions to meet their need, making systems integration an increasing necessity for a successful clinical trial. In addition, risk management of the product’s life cycle includes investigators, regulators and patients. This is where systems integration comes in, ensuring data is more accurate and consistent. If data were integrated from the start, it would be easily accessible at any point making the data review and cleaning process faster and with higher quality.

In response to the increase in demand, many new players have entered the market in recent years but according to Lin Wan, the industry still lacks innovation as there hasn’t been a breakthrough integration solution yet. In addition, more needs to  be done in terms of standardization and availability of open APIs. Panelists also observed the recent trend for real-time clinical integration in order to keep track of study progress. Another recent trend observed in larger clinical trials is the need for  integration between EDC, IVRS and central labs.

The challenges of integrating systems include ensuring validation, data security, resource availability and allocation, as well as communication between global teams. For example, panelist Carey Smoak and his former team at Roche Molecular,  were able to deliver real-time ad-hoc/monitoring reports using Enterprise Guide to create stored processes, run by non-SAS users using the SAS Add-in to Microsoft Office. They used the SAS Management Console to set up users, groups, roles and permissions. Once the proper users, groups, roles and permissions were created, then the process of creating and running stored processes was accomplished to monitor data in real-time. It took them 6-7 months to finish the project as validation, SAS components and the expertise required were very specific and not included in the traditional SAS programmer role.

In terms of best practices, all panelists agreed that before deciding on systems integration, a business should clearly define its objectives and project management workflow as project tracking is key in ensuring that resources are lined up and deadlines are met. Another crucial step is testing. Integrating systems drains a lot of time and resources so companies should always test and analyze the return on investment, then proceed with training and validation. The project team should also include all stakeholders- end users, PM, researchers and subject matter experts as well as business decision-makers.

Panelists explained that often times, small companies ask for EDC and CTMS integration when risk-based monitoring can be done without a system, on Excel spreadsheets. That is why it helps to work with vendors who understand the clinical trial process versus those that grew in the software world. Some vendors don’t have clinical trial industry expertise and their customers may end up having to implement processes around the system versus using the system to streamline the internal processes they already have in place. Researching the vendor’s customer case studies can be helpful in the decision-making process, for example. And as with everything else, communication is key in ensuring that all sides of the equation are aligned with the same vision.

 

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12
Oct

Electronic Source Data in Clinical Studies

esourcing1The move to conduct clinical trials from paper to Electronic Data Capture (EDC) has accelerated over the past 10 years in an overall effort to increase data quality, regulatory compliance and to reduce cost. However, paper is still prevalent at clinical sites, as the FDA requires record retention for CRF supporting data that is typically stored in source documents. Two years ago, in an effort to move away from paper inefficiencies, the U.S. Food and Drug Administration (FDA) issued its final guidance on Electronic Source Data in Clinical Investigations. In this guidance, the agency promotes capturing source data in electronic form to assist in ensuring the reliability, quality, integrity and traceability of data from electronic source to electronic regulatory submission.

Recently, a new product category of eSource solutions has entered the market to meet needs that EDC systems cannot fulfill. According to the Food and Drug Administration (FDA) eSource Guidance of 2013: “Electronic source data are data initially recorded in electronic format. They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation.” In other words, this is data that is entered directly into a digital format without having to first record it on paper and then transfer it to an electronic data capture solution.

Investigators like the flexibility and versatility of pen and paper, and they perceive computerized systems as a drain on their productivity. The Internet is not always easily accessible from the clinical sites, especially overseas. This is why new eSource solutions are built on tablets that can address these two hurdles. Tablet applications are designed to “look and feel” just like paper, but they offer the efficiency of an electronic document. Unlike case report forms (CRFs), which only capture the data necessary for analysis, eSource documents encompass the much broader goal of providing affirmative documentary evidence related to a subject case history and site audit, and allow for random, ad-hoc comments.

Other benefits of eSource documents include increase in clinical data quality through validation checks and the removal of unnecessary duplication of data, as well as the reduction of monitor site visits by eliminating source document verification (SDV) and enabling remote document review. However, despite the many benefits, esourced documents can still be challenged from a GCP compliance perspective.

One way for e-source solutions to comply with regulations and guidelines is to make the first data recording on paper or keep the source data in the clinical investigator’s control by entering it in a medical record or a medical record system. The FDA doesn’t regulate EMR, therefore it is not subject to 21 CFR Part 11 requirements. Collected data can be entered into eCRFs directly on the condition that it meets all regulations. If the clinical data is transferred to an eCRF from an EMR, then that EMR is considered the source. The FDA has made it clear that clinical trial monitors and auditors should have access to verify the data in the EMR.

Electronically collected data can be kept on or off-site. On-site storage can present many logistics challenges such as data corruption or loss, SOPs, software validation plan, restricted access and many others. Data not store locally should be under the control of the investigator in order for it to be compliant. Thin-client architecture, which delivers e-sourced data straight into the CRO’s remote server, can sometimes also be GCP non-compliant.

The FDA has made substantial efforts in supporting the use of electronic data solutions in the past couple of years. Among the many benefits, eSourcing helps control fraud as it is far more difficult to fabricate electronic records over paper ones.

 

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