2021 RAPS Convergence
Patient Engagement During Drug Development: Tackling the Challenges
Theresa M. Shalaby, RN, MSN|
Senior Regulatory Services Manager at Certara Synchrogenix
Patient engagement is key to support clinical trial recruitment and patient-centric drug development. Factoring patient insights and experience into all phases of clinical trial design and execution will maximize sponsors’ understanding of barriers to patients’ participation in clinical trials, issues that may cause them to drop out, and defining acceptable risk or undue burden. This process can seem daunting, but today, there are technologies available to help engage with patients and gather their input throughout the process. This session will discuss a recently developed online patient engagement portal to enable patients to provide direct feedback on clinical trials. Through this portal, patients can preview and critique protocol designs, protocol summaries, and informed consent forms (ICFs), and plain language study design and results summaries, to ensure they are clear and easy to understand. Results of surveys taken by reviewers in this portal will be presented. The session will also include perspective on partnering with patient advocacy groups to ensure that patients can comment and assess the readability of the clinical trial protocol, ICF and plain language summaries. By building this level of engagement, sponsors can not only advance clinical research and meet data transparency and disclosure requirements, but also foster closer relationships with the patient community.