Investigating Common Pitfalls in Clinical Research
Did that research administrator just say he was cut from the study due to funding issues? And, why was training IDC applied to Dr. Jane Doe’s clinical research study?
Clinical research pitfalls, such as these, may be experienced by institutions at the planning stage of a study, during a study’s execution, and sometimes through to its completion. Through research on the subject, an investigator can become familiar with common issues relevant to clinical research studies and proactively minimize or avoid potential risks. Roles within an institution beyond the investigator may be affected by pitfalls, such as departmental, pre-award, and post-award administrators who are actively involved with proposal preparation, internal review, and the management of an award, respectively.
The solution to overcoming pitfalls for all participants includes knowing the definition of clinical research, understanding the sponsor’s terms and conditions, and being well versed on institutional policies.
Clinical research, as defined by the National Institutes of Health (NIH), is “research with human subjects” (i.e., identifiable patient-orientated research; epidemiological and behavior research; or outcomes and health services research before July 19, 2018 and under 45 CFR Part 46. 101(b)(4), of which such studies on that date and later are not clinical research according to Common Rule revisions). (1) Clinical research is key to NIH’s “mission of enhancing health, lengthening life, and reducing the burdens of illness and disability.” (2)
For the investigator with plans to support this mission and conduct clinical research, possible pitfalls may include a lack of subject retention (3), which can minimize study size, diversity and responses; failing to engage subjects early enough (4), thereby ending a study without the anticipated amount of data for analysis; or, underestimating research budget costs, which could affect whether the overall study has the capital to be completed.
On the administrative side of clinical research, proposals may initially apply indirect costs (IDC) lower (or higher) than the institutional amount required, because the proposal type (tied to a specific IDC rate) is classified incorrectly. Additionally, an investigator’s effort may be inflated in proposal records because a multi-project award, reflecting only patient costs for a specific core or project, happened to include additional effort for the investigator when it should have been omitted.
While these types of issues may routinely be identified and corrected prior to proposal submission, a less common but possible administrative pitfall is an institution’s receipt of a clinical research award that was not routed as a proposal for departmental and sponsored programs approvals. To minimize risks for all and ensure compliance with institutional policies, the agreement will go through the institution’s contract negotiation process until parties come to a mutual agreement. Otherwise, and in rare cases, the study would not be allowed if parties cannot agree and finalize terms.
Applying the investigative reporter’s approach, by identifying the what, who, where, when, why, and how of an issue, can be a useful tool to uncover the best prevention and resolution for clinical research pitfalls.
Begin by determining the (What) issue that must be addressed. Follow with a list of the
(Who) names of coworkers involved as well as those who have expertise on the subject. Next, reach out via e-mail to request (Where and When) availability and the best mode of communication or conferencing (e.g., Zoom, Teams, E-mail) to discuss the topic.
Upon meeting, (Why) talk about why the issue occurred, and the reason it must be addressed. Finally, decide with the group exactly How to resolve the issue and the best procedure to ensure it is avoided in the future.
Let investigating -- taking the initiative to ask the right questions and develop solutions – lead to less stress and improvements with clinical research.
- https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf, NIH Grants Policy Statement, December 2021, 1 Glossary, page I-12
- NIH Clinical Research Trials and You, “The Need for Awareness of Clinical Research”, https://www.nih.gov/health-information/nih-clinical-research-trials-you/need-awareness-clinical-research
- https://www.sciencedirect.com/science/article/pii/S188319581000112X; “Fifteen common mistakes encountered in clinical research, Glenn T. Clark DDS, MSa,1*, Roseann Mulligan DDS, MSb,1
- https://www.sciencedirect.com/science/article/pii/S188319581000112X; “Fifteen common mistakes encountered in clinical research, Glenn T. Clark DDS, MSa,1*, Roseann Mulligan DDS, MSb,1
Authored by Aynoka Bender, Senior Sponsored Programs Specialist
Vanderbilt University Medical Center
SRAI Catalyst Committee Member
#April2022#insights#Catalyst