10
Mar

Top eClinical Trends in 2016 (2/2)

This article is the second part of our white paper: Top eClinical Trends in 2016. Read the first part here. Please visit clincapture.com/papers to download the full report and access more white papers.

T.-Taricco - PRC - ClinovoGlenn Keet is CEO at ClinCapture. He has worked in healthcare IT for over two and a half decades, and most recently was responsible for Business Development on the Optum Health Care Cloud, focusing on developing the ecosystem of providers, developers and consumers. Mr. Keet became part of Optum via the acquisition of Axolotl Corp., where he was President. He co-founded Axolotl in early 1995. Prior to his role as President, Mr. Keet was EVP over Sales and Marketing, responsible for all HIE sales to states, RHIOs and hospitals. Glenn Keet has previously held the role of VP of Business Development, and also has served as VP of Professional Services. He was the company’s Product Manager until 2001.

Changes in RBM Trends 

Recent trends in risk based monitoring (RBM) were discussed at the November 2015 CBI Conference on risk based trial management. RBM is the practice of saving time and money by reviewing or verifying only a portion of the source documents, those most likely to have the greatest potential to affect the study data.  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 more comfortable than ever outsourcing source data verification and monitoring visits to CROs. However, they now 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 sites for GCP inspections [9].

Experts point out that as more companies employ RBM, clinical trial teams should differentiate between clinical data supporting safety endpoints, efficacy endpoints, protocol endpoints, performance, and general study management [10]. 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 on 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 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 information related to the study and to obtain and document informed consent” [11].

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 [12].

ePRO to Replace Paper Soon 

Technology is also placing the patient at the epicenter of clinical research, particularly with electronic patient reported outcomes (ePRO) systems allowing patients to report clinical trial data themselves. The modern ePRO systems are designed to maximize the ease with which patients report their observations. Additionally, they better integrate with eClinical systems to capture and direct relevant clinical data faster to clinical teams. 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 [13]. 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 utilization. While the Tufts survey points out there’s been an overwhelming increase in ePRO usage in the oncology field, the main drawback cited has been the cost of using ePRO as compared to paper.

Yet, it has long been known that ePRO improves the quality of the patient reported data over paper systems or diaries; patients, being human, often don’t write down their notes as they should each day or in a timely manner. Not only can ePRO systems remind patients to record their notes, but can also track whether the patient created all their entries at once just prior to the next site visit, as is often the case in the paper world (aka the parking lot syndrome).  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 expanding capabilities as new vendors add systems each year.

eClinical 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 during the product’s life cycle includes investigators, regulators and patients; requiring systems integration to ensure data is 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 repository.

This repository 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 tranformation. 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 earlier during study conduct. 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 and Harmonization) data standards for collection 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. Many EDC systems have incorporated tools that render CTMS unnecessary for less complex trials, but a common issue with EDC-CTMS integration occurs when there are complex investigative site business practices. Many 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. As for eTMF & Safety integration, a common issue 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 can typically cost $500K and take as much as 3-6 months, which can eat up a significant chunk 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 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 [14].

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 increases pressure on 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.

Clinical 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” in 2015. 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 [15].

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].

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 2015, 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 [16].

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 also 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.

Conclusion

Although late to the game as compared to other industries, the clinical trial industry is now embracing information technology at a much greater pace.  New and improved software applications and systems are being deployed at increasingly higher rates.  Sponsors and CROs are adopting EDC, ePRO, CTMS, eTMF and other systems faster than ever, as the benefits have been proven to far exceed the expense and the FDA and other regulatory bodies are mandating electronic data submissions.  Usage of these applications and systems will continue to improve the quality of data being collected, reduce the overall costs of clinical trials, and speed new drugs and products to patients.

 

By Glenn Keet, CEO at ClinCapture
And Eric Morrie, Director of Product Operations at ClinCapture

Please visit clinovo.com/papers for more white papers by Clinovo. 

Sources:

[10] Changes in RBM Trends: Interview with Former FDA Officer

[11] Use of Electronic Informed Consent in Clinical Investigations

[12] Electronic Consent Management: Landscape Assessment, Challenges and Technology

[13] Tufts CSDD Study of ePRO Usage in Clinical Trials

[14] Electronic Submissions- The Requirement for Standardized Study Data

[15] White House Precision Medicine Initiative

[16] Fact Sheet: President Obama’s Precision Medicine Initiative

 

24
Feb

Big Data In Clinical Trials: Myths and Hopes

Billions of clinical measurements are recorded every day, generating stores of medical data beyond what anyone could have imagined just a few decades ago. The contents are called big data and the clinical research industry, although slow to see its potential, is now eager to put to use electronic versions of everything from notes doctors jot down about patients to clinical trial results.

“With enormous data come enormous opportunity,” reads the line in bold on the website of Nicholas Tatonetti, an  expert in biomedical informatics, an interdisciplinary field that combines information technology and medicine,

It’s an optimism shared widely across the healthcare industry and researchers imagine a revolution within clinical trials.

Big Data in Clinical Trials: The Hopes

“In the big-data era, the mysteries of many chronic diseases will be revealed,” said Stephen Wang, the founder of a Chinese bioscience publishing house.

Likewise, in oncology, clinicians see the possibility of using personal medical and population genomics data to improve clinical trials. For example, they can better recruit subjects likely to respond to treatments and exclude those likely to have side effects.

That could help improve the rate of drugs that make it through expensive, time-consuming clinical trials, and improve outcomes for cancer patients.

The optimism also extends to finances. McKinsey & Co. analysts estimated that using big data to make more efficient decisions could generate up to $100 billion in value annually across the US health-care system.

Big Data in Clinical Trials: The Myths

With so much hype about big data it can be difficult to weed out fact from fiction.

The data itself can cause misunderstandings. Perhaps the simplest way to define big data is as a collection of data that’s approximately bigger than one terabyte and/or is too big to handle using standard software and analytical processes.

To put that into context, by one estimation, a terabyte of data requires about 1400 CD-ROMs , 220 DVDs or 40 single-layer Blu-ray Discs. Now consider that by 2020, the overall amount of the amount of digital bits we produce is expected to equal the number of stars in the universe.

The question then becomes “how to find the gold among the dross?”

Artificial intelligence and machine learning are driving the development of tools that can process that amount of information. Supporting these efforts is the $200 million President Barack Obama invested in a National Big Data and Research and Development Initiative.

But big data is not so big that flaws become irrelevant to an accurate analysis, especially in a clinical trial where good information is critical to participants’ safety and the validity of results.

Even the solutions can have drawbacks. Take storage for example. Cloud technology (using off-site servers to store data) has developed in tandem as a place to keep the ever-growing amount of data being collected. In clinical trials, cloud technologies are also offer a way to bring down skyrocketing costs and streamline the process. But, trial investigators cite data privacy and security as major concerns about storing sensitive data in the cloud, which can be more vulnerable to cyber break-ins than off-line servers, especially if staff are not trained to understand the technology’s weaknesses.

For all the buzz, even the staunchest champions understand the limitations of big data in the complex infrastructure of a clinical trial. The idea is that big data will make the process more efficient with better results. And, as Tatonetti points out, even when trials fail they produce valuable data ready to be mined for further analysis.

“Each one of these experiments,” he said, “is a window into the human system, creating the most comprehensive and diverse medical data set ever imagined.”

Interested in the Cloud for Clinical Trials? We invite you to sign up for free for ClinCapture, our cloud-based eClinical system at clinovo.com/clincapture

12
Feb

Top eClinical Trends in 2016 (1/2)

This article is an abstract from our white paper: Top eClinical Trends in 2016. Please visit clinovo.com/papers to download the full report and access more papers. 

Clinical research is well on its way to transforming its paper-driven model to an all-things-electronic format. This paper focuses on the top eClinical trends in 2015 and 2016. 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 goal has become capturing real-time data as a continuous stream. These trends are partially the result of the prevalence of high-tech devices, sensors and wearables now entering the clinical trial industry.  Trends are also being driven by FDA embracing technology, and willingness to dialogue with experts on how to best channel this revolution in order to advance clinical research.

Higher EDC Adoption

The move from conducting clinical trials on paper to Electronic Data Capture (EDC) has accelerated over the past 10 years in an overall effort to increase data quality and regulatory compliance and reduce costs. This trend has grown because of the need to share real-time data and facilitate strategic decision making based on study 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 [1]. The eClinical solutions market, including cloud-based solutions, is projected to grow an average of 14% per year through 2020, reaching an estimated $6.52 billion, up from $3 billion in 2014 [2].

Incorporating different sources of data generates data management challenges, which is why cloud solutions are quickly gaining popularity. Cloud-based technology brings efficiency and cost-effectiveness to managing clinical data, and works for both pharma companies and their CROs. Utilizing cloud infrastructure scales quickly and streamlines data processing, improving quality and allowing for a simple, unified experience.

According to a recent report by Industry Standard Research (ISR), in 2013 just two suppliers accounted for more than 50% of EDC services. By end of 2015, the top five EDC suppliers cover 50% of the market share, which shows that the market for EDC software and services is growing [3]. 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 [4]. This explains the emergence of the next trend on our list- electronic source documentation (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” [5]. 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.

A valuable collection point of eSource is a patient’s electronic health record (EHR, also referred to as EMR), which are typically created and maintained by the patient’s primary and treating physician(s).  EHRs have been rising in utilization worldwide, and particularly in the U.S. over the past 5 years because of monetary incentives put in place to adopt their usage. In fact, CMS and Medicaid will soon be inflicting penalties on providers who fail to demonstrate “meaningful use” of an EHR.

Yet investigators have liked the flexibility and versatility of pen and paper, and they can 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 data capture solutions that are built on smart tablets can address these two hurdles. Tablet applications can be designed to “look and feel” just like paper, but they offer the efficiency of an electronic document, even when collected offline. Unlike case report forms (CRFs), which only capture the data necessary for analysis, eSource documents meets the broader need of providing affirmative documentary evidence related to a subject case history and site audit, and typically also allow for notes and 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, e-sourced documents can still be a challenge 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 an EMR. The FDA doesn’t regulate EMRs, therefore they are 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 [5].

Electronically collected data can be kept on or off-site. On-site storage can present many logistical challenges such as data corruption or loss, SOPs, software validation plan, restricted access and many others. Data not stored 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 a CRO’s or sponsor’s remote server, can sometimes be GCP non-compliant.

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

Record Adoption of eTMF

A 2015 report by Cutting Edge Information shows that adoption of electronic documentation management and control systems is expected to reach 88% by 2020. These systems are commonly known as eTMF (electronic trial master file) in the clinical trial industry.  Currently, only about 54% of TMFs are electronic-based [6]. 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 sudden drastic spike in eTMF adoption. The Veeva 2015 Paperless TMF Study (Veeva is the provider of Vault eTMF) surveyed 50 international CROs and found that 38% use eTMF applications in comparison to 21% just one year ago—a 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%).

By Glenn Keet
CEO at Clinovo

Please visit clinovo.com/papers for more white papers by Clinovo. 

Sources:

[1] Healthcare Cloud Computing Market worth $9.48 Billion by 2020

[2] E-Clinical Solution Software Market to Exhibit 13.8% CAGR owing to Increasing Clinical Trials

[3] EDC and eCOA/ePRO Market Dynamics and Service Provider Performance (2015)

[4] At the Source

[5] Electronic Source Data in Clinical Investigations

 

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

11
Dec

EDC Adoption on the Rise

smart doctor The 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.

Clinovo’s ClinCapture EDC was featured in this report along with 21 other vendors, selected out of a list of 651 EDC providers.

Try ClinCapture Free EDC

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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.

23
Nov

Pfizer and Allergan Make History with a $160-Billion Merger

merger U.S. pharmaceutical giant Pfizer and Irish rival Allergan announced a record-breaking $160-billion merger today- their transaction being the largest healthcare industry deal ever. Opponents say the companies are taking advantage of a controversial tax-saving strategy.

The companies’ say their combined entity would have more than $25 billion in operating cash flow by 2018. Under the terms of the proposed transaction, the businesses of Pfizer and Allergan will be combined under Allergan PLC, which will be renamed “Pfizer PLC.” This has officially created the world’s largest pharmaceutical company, combining the makers of drugs such as Viagra, Lipitor and Botox, to name a few.

The combined company is expected to maintain Allergan’s Irish location. Pfizer plc will have its global operational headquarters in New York and its principal executive offices in Ireland.

According to the press release, Pfizer’s innovative businesses will be significantly enhanced by the addition of a growing revenue stream from Allergan’s durable and innovative brands in therapeutic areas such as aesthetics and dermatology, eye care, gastrointestinal, neuroscience and urology. The combined company is said to benefit from a broader innovative portfolio of leading medicines in key categories and a platform for sustainable growth with diversified payer groups. With the addition of Allergan, Pfizer will enhance its R&D capabilities in both new molecular entities and product line extensions.

A combined pipeline of over a hundred drug development programs and an even larger pool of R&D and manufacturing resources are expected to propel the new pharmaceutical giant’s growth even further in the long run.

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.

life-sciences-bpo-market

                                                                                                       

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