As the number of clinical trials increase, so do the various results, that now include data from smartphones, wearables, and more sources beyond the typical structured, clinically-sourced data. The average number of data sources used in clinical trials today is about four. In three years, that number is projected to be six. That’s according to new research from the Tufts Center for the Study of Drug Development.

In their report titled 2017 eClinical Landscape Study: Assessing Data Management Practices, Performance, and Challenges, sponsored by Veeva Systems, 98% of respondents reported challenges with their clinical data management systems. This indicates that companies will need to be better prepared to collect and analyze the growing volume of real-world patient data available from the pool of growing sources.  

Contract Pharma spoke with Richard Young, vice president of EDC at Veeva Systems, who says that data is the new currency in life sciences’ knowledge-based economy, central to all decision-making on a drug’s design, development, regulatory, and commercial approval.

Contract Pharma: How is data being used to gain meaningful insights during drug development?

Richard Young: Insights mined from clinical trial data help life sciences companies deliver more informed decisions that impact the overall trial outcome, including safety and efficacy. Historically, much of the patient data in clinical trials has been collected by the physician, through observation and event reporting. However, more patient data is expected to come from a wider variety of sources such as lab tests, biomarkers, patient diaries, outcome assessments, and medical images, to name a few. The Tufts 2017 eClinical Landscape Study shows that while life sciences companies use an average of four data sources in clinical trials today, 70% expect to use an additional data source that they do not use today. More data sources will offer a more well-rounded assessment of trial quality and enable companies to identify potential success or failure earlier.

Contract Pharma: What data is needed/used to meet payer demands?

Richard Young: The life sciences industry is moving to outcomes-based reimbursement, which requires a stronger connection between healthcare and the life sciences industry so that data on efficacy, compliance, safety, and wellbeing is available to everyone involved in a patient care plan. With access ultimately driven by payers, the right patient behaviors need to be encouraged with real-world solutions that are tested in real-world environments. So the industry will need to collect data from various assessments to determine a drug’s long-term success and viability. This will require a more thorough review of how treatment costs offset health care bills, societal demands, and, of course, patient wishes. In other words, data will be needed pre- and post-approval, and throughout the life cycle of a medical solution.   

As a result, companies are increasingly incorporating outcomes data, typically recorded via patient outcome reports, ePRO solutions, patient diaries, and quality of life measures, into clinical trials and late-phase research. The Tufts survey found that the use of mHealth data to record patient outcomes will increase from 29% to 76% by 2020. In the future, data collection must be non-intrusive and gathered over more extended time periods.

Contract Pharma: How has the focus on real-world evidence impacted clinical development? 

Richard Young:Delivering solutions that work in real-world settings is critical. When reimbursed for outcomes, 100% reimbursement occurs if the patient achieves 100% of their expected outcome. And patients will only observe full outcome if they are 100% compliant with treatment requirements, which historically, doesn’t happen. Developing solutions that address patient needs and lifestyles is critical, which has led to a greater need for pragmatic and site-less trials. It’s time to bring the trial to the patient. “Pragmatic” late phase studies that incorporate real-world data in a clinical trial setting can help determine the need for ongoing changes to the design and conduct of the study and drug administration. Real-world data and evidence are now being used in many ways across clinical development, influencing study design, feasibility, patient identification, recruitment, and retention.  

Contract Pharma: What are the challenges around collecting and leveraging real-world data?

Richard Young: Real-world data should include any data source that offers useful insights. This will require the industry to collect a larger volume and variety of structured and unstructured data and turn it into a holistic view of the patient. But matching ‘real-world’ patient data to a clinical trial patient’s data can be extremely challenging, especially when the trial patient is anonymous in the clinical database. Investigator sites often use different electronic health record databases, which makes rationalizing the data between them, or integrating the data with EDC, especially challenging. Creating a single patient record from a variety of data and sources will require a different approach to data management. The concept of veracity (good enough is good enough) can be sensibly adopted, recognizing that billions of data points will create safety in the knowledge that certain, limited, quantifiable errors can be left as raw data and unaddressed. At the same time, we must address the challenges of regulatory acceptance, patient privacy, and data storage.  
 

 

Richard Young is vice president for Veeva Vault EDC. With almost 25 years of experience in life sciences, Richard is known for his expertise in data management, eClinical solutions, and advanced clinical strategies. Prior to Veeva, he served as vice president of global consulting partners at Medidata Solutions, where he established new partner relationships with leading life science consulting organizations. Richard also spent a number of years leading the mid-market Europe, Middle East, and Africa sales team at Medidata, where he was responsible for all customer interactions and driving new business. In his roles, Richard spent considerable time consulting on adaptive trials, risk based monitoring, big data, mobile health, and other major data strategies with sponsors and partner organizations across the globe. He can be reached at richard.young@veeva.com.