Defining the New Normal in Clinical Research to Support the World’s 336,747 Research Studies
– by Jennifer Goldfarb, MSN, RN, CCRP
As of April 21, 2020, according to clinicaltrials.gov, there are 336,747 research studies registered in all 50 states and 210 countries throughout the world. Clinical research is a delicate ecosystem within the healthcare system that can easily be advocated for as an essential healthcare service. It is a highly complex, intensely regulated and regimented environment. It is a critical component of healthcare that drives scientific and medical advances to promote health and treat illness. This environment has suffered unprecedented disruption and chaos during this pandemic. While we hunker down in our homes, waiting for this storm to pass, clinical research conduct is being adapted, paused, and even discontinued, in every therapeutic area.
What is the impact of potentially disrupting 336,747 research studies across the globe due to the challenges caused by the pandemic? These challenges include necessary quarantine, clinical research site staff and study participant COVID-19 infection, site closures, supply chain disruption, travel limitations and stay-at-home orders. The impact will vary for each individual study, based on the nature of the research study, the disease and investigational product being studied, the geographical location of the study site, and other details. The impact on our public health in the years to come is unknown; however, it is hard to believe that it will not be felt. The way we adapt now may act to minimize harm, both now and in the future.
How do clinical research sites adapt to minimize the disruption, while protecting the safety of clinical research participants and maintaining the integrity of the research? On March 18, 2020 the FDA released Guidance for Industry, Investigators, and Institutional Review Boards to help address the many concerns related to the conduct of clinical research during the COVID-19 pandemic. They updated this guidance to include a Q&A appendix on April 21, 2020.
Dr. Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs, emphasized that clinical researchers must prioritize the study participant’s safety. Dr. Shah said that we must find the delicate balance of supporting ongoing clinical research conduct in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.
The IMA Clinical Research Site Network, with sites located across the country conducting research in multiple therapeutic areas, has always prioritized and ensured study participant safety and quality data collection and reporting. This has been achieved through dedicated and experienced investigators and staff, expert project management, and quality oversight. We do not lose sight of these priorities, even in the thick of COVID-19, with its significant and seemingly unending impact on life as we once knew it to be. We instead have risen to the challenge, like many of our clinical research colleagues throughout the world, going above and beyond to ensure that we do everything possible to protect participant safety and the integrity of our studies.
IMA Clinical Research is partnering with Sponsors, CROs, and Institutional Review Boards to evaluate each study individually, and adapt to best support the needs of each study and its participants. Advanced planning and effective communication have been the keys to our success. Study visit schedules, based on the study protocol’s requirements for safety and efficacy assessments, are being anticipated far in advance, with clear contingency plans in place. Study visits are not only important for their required assessments but also because they may provide an opportunity to supply study participants with study drug, supplies, and support. We have worked with Sponsors to operationally support a protocol modification to allow for phone and virtual visits. We have put new processes in place to protect participant safety, including screening procedures recommended by the CDC. We have adjusted participant visit schedules, in consultation with our Sponsors, to eliminate unnecessary in-person visits. We have accommodated numerous remote monitoring visits, facilitated by the use of our CTMS system, CRIO, that allows for eSource and eRegulatory documentation. These are just a few examples of what IMA Clinical Research has done to support our study participants and research studies over the past 6 weeks. We add to this list every day, without hesitation, and will continue to do so over the coming months, and years, as needed.
While there are still many unanswered questions about the impact of COVID-19, one thing that seems clear is that the return to normal will be gradual. It will look different from the past, COVID-19 having forever changed our “normal”. Clinical Research sites must plan now to be prepared for this ongoing adaptation to our new normal so that we can continue to conduct clinical research. This is essential because there is one thing that will not change. We will always need clinical research to support scientific and medical advances to promote health and treat illness.
–About the Author: Jennifer Goldfarb is a clinical research industry expert and leader with over 20 years of nursing, clinical research operations and management experience. She is the VP of IMA Clinical Research.