Clinical research plays a critical role in discovering new treatments and innovations for combating the complex diseases and illnesses we face today, including both therapeutic solutions and vaccines for the COVID-19 virus.
But what should health systems—both academic and nonacademic—do in the current crisis to protect their ongoing clinical trials and maintain research operations? According to National Institutes of Health (NIH), there are over 330,000 clinical studies being conducted around the world. The US is home to 34% of those studies—a third of which are in active recruitment.
The research community needs to plan for the multitude of potential scenarios related to COVID-19 and how they may impact faculty, staff, students, and study participants. Below are five steps research leaders should take to ensure continuity in operations during this outbreak and prepare their institutions for the future:
1. Review and follow the regulatory guidance and notifications provided by the FDA, NIH, and OMB.
- FDA guidance on conduct of clinical trials of medical products during the pandemic:
- Recognizing that COVID-19 may impact the conduct of clinical trials of medical products, the FDA has issued guidance to help sponsors ensure the safety of trial participants, maintain compliance with good clinical practice, and minimize risks to trial integrity.
- Four NIH notices related to the impact of COVID-19:
- Late Application Submissions: Provides guidance to NIH applicants and recipients whose ability to submit applications in a timely manner may be compromised.
- FAQs on Proposal Submission and Award Management: Addresses general questions associated with proposal submission and award management.
- Administrative Flexibilities to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19: Details short-term administrative flexibilities NIH is providing to research institutions to enable them to manage administrative, financial, and audit requirements.
- Guidance for NIH-Funded Clinical Trials and Human Subject Studies: Provides guidance outlining the flexibilities available to recipients conducting these trials and studies.
- OMB administrative relief for recipients and applicants of federal financial assistance directly impacted by coronavirus:
- The OMB issued a memorandum that authorizes granting agencies to provide flexibility regarding availability of COVID-19 research funding, proposal submission practices, and post-award management activities to grantees whose business activities have been affected by COVID-19.
Additionally, institutions should review guidance disseminated by other federal agencies such as the NSF, DOD, NASA, Department of Energy, US Army Medical Research Acquisition Activity, US Department of Agriculture, FDA, HHS, Office of Justice Programs, NSA, and DARPA.
2. Develop communication protocols to be immediately released to your organization’s research community. This may include:
- Setting up a dedicated website for ongoing communication and resources related to research operations.
- Developing personalized messages to staff, faculty, students, and trial participants to inform them of how ongoing clinical research operations will be impacted.
- Updating policies and procedures for immediate dissemination to principal investigators (PIs), staff, and other research and healthcare workers concerning managing research in the current climate.
- Providing COVID-19 awareness training to all research personnel.
3. Identify the operational impact on research services and units, and determine a plan to address the following areas:
- Research Operations: Maintaining research support staff and keeping mission-critical projects running.
- Research Administration: Covering pre-award, post-award, contracting, and compliance services.
- Research Technology: Access to administrative systems and support for research equipment.
4. Determine the risk/benefit ratio of each clinical trial, including those with human subjects, and determine which studies should continue and which should be temporarily paused. Primary studies and procedures to consider for continuation include those that:
- Directly support vaccine or therapeutic research for COVID-19. Several government agencies have developed specific funding opportunities for new research for COVID-19. Examples include those from NIH, NSF, and HHS.
- Pose low risk to participants and allow for protocol modification.
- Do not involve a drug, device, or stabilization of a high-risk psychological condition.
- Involve the administration of drugs or monitoring of devices that provide direct therapeutic delivery to study participants.
- Do not involve person-to-person interaction with participants.
For any type of clinical study, researchers should consider stopping enrollment if virtual consent is not an option.
5. Each PI and director, in collaboration with their research group and/or division, should develop an essential research operations plan. At a minimum, the plan should cover:
- Personnel who can make operational and trial study decisions in the event the PI is unable to direct operations.
- Communication methods that the research group will use with study participants and clinical research staff.
- Range of operational activities that should be ongoing, scaled down, suspended, or delayed.
- Access to and protection of essential lab specimens and equipment for essential operations.
- Remote monitoring structure for teams to manage ongoing clinical trial research.
- Sponsor requirements required to be submitted.
- Submission of proposals.
When an epidemic strikes, the fear and heightened anxiety that comes with it can be distressing. However, as we have learned in every crisis faced by our nation, we are not defined by the circumstances we face, but rather how we respond to them.
Published March 27, 2020