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.

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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.


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.


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.


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


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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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.


Silicon Valley BioTalks “eClinical Systems Integration” Takeaways

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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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.




The Data Integration Challenge for CROs

Contract research organizations (CROs) always strive to enhance project oversight and decrease costs while adding value. As clinical trials are becoming more complex, multiple CRO partners often need to collaborate on a single project, and each CRO has its own portal and varying sets of reports, which means transferring information can be problematic. Even in the cases when the sponsor and CRO use the same CTMS, for example, APIs need to be set up for each trial. Simplifying data exchange is therefore crucial to fulfilling their trial-related duties.

Some find a workaround with CTMS by extracting data in spreadsheets, sending it to the sponsor and then importing it into their system manually. But they can run into problems such as inconsistent data requests or problems in mapping it to the sponsor’s back end data tables. Others use an SQL database or SharePoint for data entry, and skip CTMS altogether. That, however, presents many operational issues of providing consistent data extracts in the right format and manually managing their data.
Some sponsors also work with CROs on implementing CDISC clinical trial data models such as the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM). The CROs convert their studies into a common SDTM structure in support of eCTD and Integrated Summary of Safety analyses for a filing. Sometimes these studies were not done in-house which results in inconsistent eCRFs so the SDTM format benefits both internal data inspectors as well as the FDA. Using the SDTM structure has helped standardize the data structure (Treatment Names, Treatment Codes, Visit Names, Visit Numbers, MedDRA Encoding Version, and coding for Disposition Status). The table below further describes some materials that are helpful for the CRO to implement the SDTM conversion.


Credit: Outsourced Data Integration Project with CDISC SDTM and ADaM Deliverables

To learn more about the new trends and solutions in eClinical systems integration, register for our next Silicon Valley BioTalks event happening on October 8th. Panelists would address questions such as: What are the key principles for a successful outcome? What are the new trends and players in place that are tackling the high cost of integrated solutions? Why are eClinical systems vendors and CROs instrumental in making progress and how can they accelerate this process?

11th Silicon Valley BioTalks
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