A report by NPR, based on federal clinical trials data, showed that the COVID-19 pandemic has forced hundreds of clinical trials to stall. Academic medical centers, hospitals and community research centers have all seen some clinical trials stopped or paused.
While some research institutions are slowly re-opening their campuses, many investigators and their staff are still working remotely from home, at least part time. This has had a significant impact on both industry sponsored and investigator initiated clinical trials.
Some investigators, residents and fellows needing to do their scholarly research, are keen to initiate studies, particularly those that may not require participants to make in person visits to medical facilities. The FDA has issued guidance on conducting clinical trials during the pandemic. But writing a protocol while working from home may pose special challenges for investigator-led trials.
Guidance during protocol writing process
Investigators sometimes rely on research staff, IRB members, medical librarians or mentors to guide them in protocol-writing. Working remotely can pose a challenge during the protocol-writing process when this guidance is not readily accessible.
Although many institutions have downloadable templates for protocols, they often do not cover the varied range of types of studies. Nor do they provide step-by-step, interactive guidance through the protocol-writing process.
Collaboration with colleagues
Many investigator-initiated research protocols require input from colleagues. Whether the study involves different clinical specialties or coordination with experts in pharmacy, labs or other functions, often the principal investigator seeks a review from colleagues. In some cases, the researcher may seek collaboration from experts at other institutions.
Downloadable PDFs or Microsoft Word documents require care to manage versions and coordination of edits and remarks. This asynchronous approach may cause confusion and frustration for everyone involved.
A cloud-based protocol-writing tool allows this collaboration to occur smoothly.
Access to regulatory requirements
Searching for regulatory information, such as IND forms, IDE guidelines and FDA instructions can be cumbersome when working from home or a remote office. An online tool with links to regulatory resources can expedite this process.
Scheduling IRB Reviews
One challenge — even before COVID-19 — often cited by investigators as a point of frustration has been IRB feedback that a protocol is incomplete and requires revision prior to IRB review, or the process of responding to IRB queries after IRB review and having to clarify elements of the protocol. Many protocols are returned to the investigator due to common issues — incomplete sections, missing regulatory documents, incorrect protocol type, etc.
A well-written, complete protocol that complies with the latest regulatory requirements and aligns with institutional policies is a significant step in accelerating the IRB review process.
However, even an efficient and timely review may be problematic if the IRB is overwhelmed with a flood of new protocols in a time of pandemic and a keen interest in studying it. In this case, an external IRB can provide much-needed support in reviewing and expediting protocol reviews as a complement to the institutional IRB.
Writing research protocols can be a complex and time-consuming process. Working remotely has made it even more difficult. With cloud-based collaborative tools, such as Protocol Builder, investigators can more easily meet these challenges and continue to start critically important new studies. Additionally, leveraging an external IRB with experience in frequent and remote reviews can ease the burden on already-stressed research institutions.