Looking across the pharmaceutical, biotech, and medical device industries, we can see many different changes to how trials are being conducted during the COVID-19 pandemic. The pandemic has highlighted the importance of some existing needs and created new requirements along the way.
In a recent Mednet survey, 81% of customers indicated they needed to make changes to ongoing trials due to COVID-19. The types of changes made by research teams varied. More than a quarter (28%) made changes to include additional safety measures for trial participants, while one in five (20%) made changes to protect site personnel. More than two-thirds (68%) reported making changes to enable certain roles to perform tasks remotely, while nearly two-thirds (60%) indicated they made adjustments to collect data from patients remotely. Many research teams also noted they made changes to case report forms (CRFs) and to their electronic data capture (EDC) platforms, 68% and 52% respectively.
The variety and urgency of these changes illustrate the continuing need for greater flexibility as clinical trial teams respond to the global pandemic. Business as usual is no longer an option.
The U.S. FDA published, “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency”, which was updated on July 2, 2020. The guidance was specifically developed “to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency.”1 The document discusses considerations for on-going trials but the bulk of it is dedicated to an Appendix of 24 questions and answers. The topics are broad and cover numerous aspects of a trial. Obtaining informed consent, processing protocol amendments, remote monitoring, and logistics for trial supplies are just a few of the issues discussed.
Throughout the guidance, the agency continues to prioritize the safety of patients and the integrity of the trial. They attempt to offer recommendations for a host of irregular situations that may or may not be long term concerns. The guidance provides great insight into how sponsors, agencies, and CROs continue to shift, modify, and totally rethink their practices. It is hard for any of us to know what temporary practices may become permanent once the pandemic subsides.
Looking toward the future, approximately two thirds (65%) of survey respondents believe the pandemic will have a lasting impact on the design and conduct of clinical trials. Nearly a third (29%) of respondents are unsure of the lasting impact, with only a small percentage (6%) suggesting they believe the pandemic will not have a lasting impact. If the present is any indication, we will continue to need more flexibility as we approach clinical research. We are already seeing new processes and new trial designs occurring in new environments. We are also experiencing a greater acceptance of remote operations. Of those respondents who indicated they anticipate the pandemic will have a lasting impact, nearly all (95%) said they foresee increasing the pace of enabling certain roles to perform tasks remotely, while most (79%) said increasing the pace of enabling virtual participation of participants will be a factor. Nearly two-thirds (63%) said they believe research teams will need to adopt new technology to address new study processes and designs.
Remote work enables teams to continue research activities during travel restrictions and lockdowns. This is a new kind of agility that helps teams to respond to changing requirements more quickly. However, it requires a broad technology platform to connect distributed teams. Clinical research technologies must be robust enough to support complex study designs and maintain trial integrity while affording the flexibility to pivot quickly and efficiently, without negatively impacting patient safety and trial integrity.
The COVID-19 pandemic showed us how quickly we NEED to adapt, how quickly we CAN adapt, and where we need to seek short-term and long-term improvements. It continues to show us the importance of flexibility in a world of constant change. In some ways the pandemic has been a mirror for our industry. It reflects how well we are using our own processes, technologies, and resources, and it has highlighted our strengths and weaknesses.
As clinical research teams continue to find new ways of operating, we will also continue to need new and greater forms of flexibility. Flexibility continues to be a foundational principle in Mednet’s product strategy. As we build and enhance our solutions, our customers can be assured that we are committed to providing flexible capabilities that will adapt to evolving requirements and stand the test of time, even amidst uncertainty.