Contributed Commentary by Richard Young, Henry Levy, and Jim Reilly 

March 18, 2020 | New methods for collecting, analyzing, and sharing clinical trial data are needed in the era of personalized medicine. Beginning this year, we’ll see new trial designs being introduced that recognize a larger, broader section of the patient population. These designs will include longitudinal studies that offer historical patient perspectives, integrate the use of synthetic data based on real-world outcomes and predictive analytics, and combine results from patients across multiple sites – both real and virtual. 

New trial designs will usher in a new era of clinical data management 

As clinical trials evolve in the age of precision medicine and new trial designs emerge, pharma companies will be called upon to develop new approaches to collecting, using, reusing, and sharing trial data. Single use, throw-away data has been the mainstay within the clinical trial ecosystem, with as much as 80% of all data that’s collected being used only once. 

In the coming year, we expect to see the growth of reusable data within the industry. EHR data will be combined with data from multiple trials to provide a repository of multi-sourced, multi-purposed data, analytics, and insights. Real-world evidence will be collected and examined throughout a patient’s lifetime to provide an historical perspective. This data will be applied not only to the individual patient, but also to other patient populations to eliminate redundancy, streamline processes, and reduce trial costs. 

Data management solutions that treat flexibility as a norm, rather than the exception, will be critical in enabling sponsors to change trial designs as new insights emerge. Large volumes of data will be captured both from conventional sources, as well as from new sources such as wearables and sensors, enabling more inputs to be operationalized in real-time. Companies will have greater latitude, not only in determining how trials are run, but also, in making trial design modifications on the fly. This transition from clinical data management to clinical data science will also give rise to a new view of the patient as a key contributor to the data science process rather than as a contributor of fluids and biomarkers. 

Synthetic data unlocks the key to greater trial efficiency 

With today’s emphasis on outcome and value-based payment initiatives, the ability to analyze real-world patient data is important to discovering the best treatments and improving patient outcomes. EHR and clinical trial data sharing has emerged as a primary way to speed disease diagnosis and treatment. In the coming year, we anticipate the use of synthetic data to increase trial efficiency, reduce costs, and improve outcomes for all stakeholders, as well as safeguard against GDPR compliance risk. 

Rather than collecting data from patients assigned to a control or standard-of-care arm, real-world data can be modeled for specific patient groups and potential outcomes. The use of this synthetic data holds vast promise in determining therapeutic regimens, identifying and mitigating drug side effects, and optimizing dosages and synergies in multi-drug therapies. 

Synthetic data also has the potential to address compliance risk and privacy concerns. Real-world patient data is often siloed due to privacy concerns, but the use of synthetic data can be more accessible. While the full ramifications of GDPR within the healthcare industry has yet to be fully understood, one way to avoid potential compliance risk will be through the use of synthetic data. 

Innovative patient enrollment and retention techniques will improve trial outcomes 

Low trial enrollment and retention presents a challenge throughout the industry, with up to 90% of studies in the U.S. experiencing significant delays in recruitment and enrollment. Nearly one-third of all trials under-enroll, and only 7% meet their target enrollment number on deadline. Much of the challenge stems from geographic mismatch of site to patient, poor patient engagement, and lack of trial awareness among patients. 

In the coming year, we anticipate that pharma companies will show measurable improvements in enrollment and retention through new methods that bring trials closer to patients. These include hybrid trial delivery, community-based sites, and digital engagement. Hybrid trials (as opposed to the all-or-nothing sounding term “virtual”) deliver parts of a trial digitally – from activity trackers and telehealth, to e-consent, ePRO, and social apps. 

Another novel idea being tested is the ability to professionalize remote or rural healthcare providers by outfitting them with training and equipment to deliver investigational treatments. Improvements in social engagement and data access will also drive better trial awareness and retention. All these methods will collectively improve trial enrollment throughout the industry. 

Value-added trial designs improve patient outcomes in 2020 

New clinical trial approaches will enable a more competitive, innovative, and efficient framework for developing life-saving medicines for a range of patient needs. While clinical trials are long and complex, innovative companies will leverage the latest scientific advances and systems to streamline investigative approaches and create efficiencies. 

Richard Young is vice president of clinical data strategy at Veeva Systems. With almost 25 years of experience in life sciences, Richard is known for his executive vision and proven operational experience in data management, eClinical solutions, and advanced clinical strategies. He can be reached at richard.young@veeva.com.  

Henry Levy is the general manager of Veeva Vault CDMS at Veeva Systems. Henry has overall responsibility for the Veeva Vault CDMS product and is focused on having Veeva become the market leader for data collection and cleaning for clinical trials. Henry has spent 25 years working to transform how the $1.7 trillion life sciences industry improves patient health. He also represents Veeva as president of Align Biopharma and Align Clinical CRO, two industry standards groups dedicated to improving how healthcare providers engage life sciences companies, as well as making it easier for sponsors and CROs to work together during clinical trials, respectively. He can be reached at henry.levy@veeva.com.  

Jim Reilly is Vice President of Clinical Market Strategy at Veeva. Jim is responsible for customer engagement, market adoption, and strategic alliances. For the last 15 years, Jim has held a variety of senior positions in life sciences technology, where he has led software delivery and sales efforts in clinical operations, regulatory, clinical data standards, and content management. Jim holds an MBA in Information Systems from Villanova University and a B.S. in Neuroscience from the University of Scranton. He can be reached at jim.reilly@veeva.com.