As a result of the current global COVID-19 public health crisis, interest in and awareness of relevant clinical research has emerged as a path to access new and innovative treatments. TransCelerate is equipped to raise clinical trial awareness and access and help facilitate an increase in focus on the inclusion of the patient experience throughout drug development.
During the“Patient Engagement Collaborative monthly teleconference, March 26, 2020,”patient advocacy groups and their patient communities were asked to share their feelings about the current state:
Patients expressed a higher sense of urgency, anxiety and stress about their current medical conditions and what the impact of re-prioritizing research to address COVID-19 will have on finding cures for their conditions or those of their loved ones. For patients enrolled in ongoing clinical trials, communication and information sharing is key to managing this additional burden.
For non-COVID-19 related clinical studies, the current environment may present an additional opportunity to engage with patients in the design and execution of clinical studies. Please consider the following:
- For non-COVID-19 clinical studies, which may have been re-prioritized during the pandemic, this provides an opportunity to assess how the Patient Experience Initiative Toolkits can be integrated into a study or program level planning now. This time can be used to re-assess how planned studies will measure patient experience in the future. Can the Patient Protocol Engagement Toolkit (P-PET) be used to assess protocols not yet finalized and can implementation of the P-PET be planned and budgeted for now? Pick the pieces of the toolkit that align best with your program/study needs and modify them to make them be fit for purpose within your organization.
- Non-COVID-19 clinical studies which have already implemented the Study Participant Feedback Questionnaire (SPFQ) Toolkit have an opportunity to gauge and measure the patient experience and impact of COVID-19 on their participation in the trial.
- Sponsors conducting patient advisor boards (PAB) about studies to be started in the future will need to be prepared for patients who are afraid, misinformed and passionate. Leverage the P-PET PAB Satisfaction Survey Template to provide patient advisors with an optional anonymized post-panel satisfaction survey to provide sponsors with valuable information to improve their ways of working with patients, build trust with and demonstrate respect for the patient community and mitigate any anticipated consequences of conducting patient advisor panels.
Now more than ever, including patients in the development of new medicines and therapies will require optimized patient experience tools and methods embedded throughout the development process. The TransCelerate P-PET and SPFQ Toolkit are ready to be leveraged to provide more effective ways to engage with patients in the design and execution of clinical studies.
About the author:
Jean Sposaro is the Global Business Capability Lead for Clinical Trial Industry Collaborations at BMS. Jean has a master’s in jurisprudence healthcare Pharmaceutical Law and Policy, is Pharma Compliance and Lean Six Sigma Green Belt Certified and possesses over 30 years of Healthcare, Pharmaceutical and Clinical Operations experience. Roles she has been involved in include leadership roles in Global Pharmacovigilance and Epidemiology (PV), Clinical Safety, Clinical Quality and Continuous Improvement, Patient Network Management, Regulatory Policy, Bioethics and Program Management.