COVID-19 has presented a variety of challenges. The way people live their lives and conduct their work has been disrupted. There are restrictions that limit where they can go and what they can do, but those limitations are not confined to home life or office settings. COVID-19 has had important implications for clinical research and patient management in particular. In this article, we will review our top strategies for navigating clinical studies during COVID-19.
1. Modify Existing Protocols for Safety
Many studies were put on-hold but as the pandemic rages on and escalates, finding a way back to active trials makes sense. Modifying existing protocols for safety lets that happen. One adjustment that arose at the onset of COVID-19 is that all protocols needed to be adjusted to protect subject safety and reflect whatever restrictions may be in place at the site location. These adaptions are critical for safety and study continuation.
2. Expect the Unexpected
Some studies were derailed when COVID hit because they didn’t have a catastrophe plan; if they had a plan, the outcome may have been different. Smart contract research organizations (CROs) took this lesson to heart. Current and future studies need to include a plan to mitigate future issues, whatever they may be. This will help studies prepare for a second wave or another disaster.
3. Anticipate Delays
Issues regarding patient recruitment and study functions are not limited to the activities of the study itself. Studies also need to assume that there will be delays in the way that paperwork is processed at a regulatory level. Many governments are not meeting as regularly as before the pandemic and those that are have experienced no dearth of documents. There are bottlenecks and backlogs. However, if studies plan for this type of delay, the impact will be minimal.
Consent is also a problem in studies during a pandemic. Regulations vary by country, and these concerns may need to be managed remotely as a result of COVID-19 restrictions or subject preferences stemming from fear of contagion even if there is no legislation to that effect in place. There may also be an issue with consenting patients on ventilators. At Pharm-Olam, we have worked on dozens of studies that involve subjects on mechanical ventilation or otherwise in the ICU. We find that best practices include putting a plan in place that helps monitor patient consent at each level and initiating remote consent where possible.
5. Develop a Communication Plan
Communication changes in a pandemic. Making sure that you have secure communication options available and in place before they are needed improves interactions with would-be subjects, connections with investigators, and relationships with Sponsors. For instance, enrolling study participants during a COVID-19 lockdown may be difficult if not impossible. However, studies with a developed communication plan to navigate a lockdown have been successful in enrolling patients.
6. Focus on Engagement
In this case, best practice would be to initiate and maintain communication with potential subjects digitally until the study opens. Consider what patients may need (or want) to know to keep them engaged. Remember that many need treatments, and they need you to remain communicative no matter what happens. Even if a study is on-hold indefinitely, recruitment materials can still be sent to and reviewed by study candidates.
7. Initiate Remote Monitoring
Many countries have stay-at-home protocols and new restrictions are expected. Prepare for site closures by creating a system that employs some type of remote monitoring. To use tele-visits in a clinical trial, you will need to include that option in the study protocol and establish secure connections with investigators.
8. Centralize Efforts Where Possible
One risk posed by continuous adaptions to something as unpredictable as COVID is that you end up constantly reacting to problems. If you aren’t careful, you’ll end up with duplicate systems and introduce the possibility for error. Centralizing your efforts allows for a single source of truth, which is critical when circumstances frequently change. Centralization can also introduce opportunities for synergies across studies.
Effective Patient Management During a Pandemic
Navigating clinical studies during COVID-19 is challenging, but not impossible. Taking steps to modify existing protocols for safety and putting contingency plans in place helps tremendously. CROs should also work to establish consent and develop a communication plan that includes patient engagement. Remote monitoring and centralization help keep studies moving during the pandemic.
Pharm-Olam has several clinical studies underway, including important COVID-19 research. These best practices have enabled us to stay productive and keep research progressing even while parts of the world effectively shut down. Our team can help you adapt your study to the new COVID-19 reality. Click this link to learn more about the services we offer.
Chandrakantan, A. (2020). Navigating Clinical Trial Recruitment in the Midst of COVID-19. Applied Clinical Trials Online: https://www.appliedclinicaltrialsonline.com/view/navigating-clinical-trial-recruitment-midst-covid-19
Gaba, P., Bhatt, D.L. (2020). The COVID-19 Pandemic: A Catalyst to Improve Clinical Trials. National Review of Cardiology 17, 673–675: https://doi.org/10.1038/s41569-020-00439-7
McCarthy, L. (2020). Four Tips for Navigating Patient Recruitment During COVID-19. Clinical Trial Leader: https://www.clinicalleader.com/doc/four-tips-for-navigating-patient-recruitment-during-covid-0001
North, C.M. et al (2020). Improving Clinical Trial Enrollment — In the Covid-19 Era and Beyond. NEJM: https://www.nejm.org/doi/full/10.1056/NEJMp2019989