Transformative applications in observational studies and pragmatic clinical trials
As the healthcare system continues to progress in the use of technology to track and improve patient care, Electronic Health Record (EHR) systems are becoming a burgeoning source of Real-World Data (RWD) for researchers and manufacturers alike.
EHRs can be a cost-effective way to identify, access and analyse data needed for peri- and post-approval research studies. In this webinar, we will focus on how RWD can be quickly applied to Observational Studies and Pragmatic Clinical Trials (PCTs), as well as what challenges researchers face in successful application of RWD to these studies.
This webinar will discuss the advancements, opportunities, and challenges around the current and future use of Real-World Data from EHR systems in observational studies and pragmatic clinical trials. Attendees will gain valuable insights on:
- The current demand for Real World Data to provide post-approval reporting and inform manufacturer business decisions
- Development of RWD guidelines and requirements by regulators in the US and EU markets
- How RWD is being applied to post-marketing research including observational trials and Pragmatic Clinical Trials
- Jim Carroll - Vice President, Real World Evidence
- Rob Sambrook - Divisional Principal, CS&S Epidemiology
Observational studies and pragmatic clinical trials
Observational Studies, being non-interventional in nature, have traditionally been conducted by collecting data via the establishment of patient registries. This can be an expensive start-up process and long term management can be cumbersome. As EHR databases continue to grow and offer an abundance of RWD, their use as viable sources for retrospective and prospective analyses can grow as well with less cost and resourcing impact.
Pragmatic Clinical Trials (PCTs) are known for having broader eligibility criteria than Randomized Clinical Trials (RCTs) and are conducted on a much larger patient group in order to produce more generalized population-based results. Identifying patients for PCTs can be a laborious process that requires dependence on providers’ initiative to drive patient recruitment.
EHR systems are becoming the backbone of PCTs and provide a method to identify, enroll, and monitor patients while capturing treatment details and outcomes for study as the trial continues. In this case, use of the EHR system can reduce the cost of these studies through automating the patient identification process as well as others.
While EHRs demonstrate a great benefit to the post-approval clinical research community, challenges do exist, some of which will be addressed as EHR technology progresses and some of which are inherent to any secondary data source. Researchers will have to be aware of these nuances in data capture and system interoperabilities to leverage the usefulness of EHRs in conducting scientifically sound studies and trials.
As EHR-driven studies advance with this ever-present RWD source, biopharmaceutical, medical device and diagnostic manufacturers should look to the benefit these studies can provide to stay ahead of the curve with real-world evidence that supports the value of their marketed products in continuing to expand access and support reimbursement.
- Market Access
- Pricing & Contracting