The COVID-19 pandemic has forced quick thinking and adaptation in clinical trials to ensure patient safety and, where possible, continue research and preserve study integrity. Changes have impacted protocols, use of technologies, data collection, and how patients are participating in trials.
On June 11, we hosted the first of a series of mdWebinars to facilitate discussion and debate among patient groups, pharma/biotech, CROs and service/technology providers around how we can build more flexible, resilient and patient-focused trials. Our panel featured:
Our moderator Valeria (Vale) Nicoli-Carr, VP, Patient Engagement and Recruitment at mdgroup opened the webinar by setting the scene on the impact the COVID-19 pandemic has had on all our lives, but in particular how it has affected clinical trials and patients in those studies. Vale referenced recent surveys showing the impact on clinical trial enrolment and the challenges that reduced in-person interactions bring.
Next, it was the turn of the panel to talk about our first question:
What have we learned from the impact of the pandemic on clinical trials and patients?
Nick Hicks, Director, Commutateur Advocacy Communications, who supports life science leaders to develop patient engagement and advocacy strategies, kicked us off with his answer from the perspective of patients, patient advocates and patient groups.
Nick discussed five key points (see image above), but said that “the overriding message is that those companies who already have a strong patient-centric culture and who are already working closely with patient advocates, patient groups or patients, in the design of clinical trials are going to be able to use this transition to a ‘new normal’ as a source of competitive advantage.”
Rhonda Henry, VP, Patient Centered Trials at PPD, a clinical research organization (CRO), leads a group responsible for providing customized patient-centric strategies to engage, recruit, and retain patients throughout a clinical trial, as well as enhancing the patient experience. Rhonda offered her experience that pre-COVID, conversations with biopharma companies about procedures like tele-visits, remote e-consent and home healthcare, uncovered interest, but that in general, they were too novel for inclusion in trials.
During the pandemic, we’ve discovered there’s a “cost of not being innovative enough” – we’ve had to adapt and introduce or expand these measures to keep trials running and maintain continuity of care to patients.
LaRee Tracy, Director, Biostatistics, Phastar, previously worked at the FDA in the Office of New Drugs, with a strong focus on the development of clinical trials and analysis of trials to support new drug approvals. LaRee said that the pandemic has created a new way of thinking across the clinical trials and regulatory space overnight.
Regulatory agencies were quick to respond with new guidance and regularly updating that guidance while the pandemic and its consequences are unfolding. Clinical trials have had to try to rapidly implement protocol modifications and it was expected that there would be an increase in protocol deviations and violations because patient assessments can’t be performed as originally planned or patients have dropped out of the studies. This, of course, has an impact on the quality of data collection because data points are now missing.
To hear the panellists discuss considerations as restrictions are eased or lifted, and what we can take away from the experiences during the pandemic so far to design more resilient, flexible and patient-focused trials, please watch the replay: