Q&A with Wright Center ClinicalTrials.gov Program Administrator, Alanda Perry Jones
Q&A with ClinicalTrial.gov Program Admininstator,
Alanda Perry Jones, MA, CCRP
During recent workshops, she reviewed a summary of the 2017-2018 changes, delved into case studies to better understand NIH’s expanded interpretation of the definition of a clinical trial, and provided resources for researchers to use as they develop their proposals.
What are the takeaways you want from these workshops?The main takeaways are these: NIH has implemented many policy changes over the past year to improve transparency and accountability in human subject research, especially clinical trials. NIH uses a broad interpretation of the definition of a clinical trial. This includes certain mechanistic studies, which are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.
What are the major changes?
- The funding opportunity announcement (FOAs) will specify whether clinical trials are required, optional, or not allowed.
- NIH has revised their proposal form to consolidate and streamline human subjects information. Investigators must use the new Form E.
- Multi-site studies must use a single IRB.
What are some of the questions you are getting?
Many investigators are asking whether their particular study qualifies as a clinical trial. Research administrators at VCU can provide guidance on this, but with so many changes occurring at once, the best source of truth is the NIH program officer.
What is your role at the Wright Center for changes like these?
My specific role is ensuring that VCU is compliant with ClinicalTrials.gov regulations, which require outreach and education, as well as input from the research community. The influence of ClinicalTrials.gov over research will likely continue to grow as long as transparency and accountability remain a priority. My goal is to make sure that we’re meeting our important reporting obligations in a way that is as painless as possible.
If you need additional information please visit the National Institute of Health website at: grants.nih.gov/policy/clinical-trials.htm or contact Alanda Perry Jones at: perryar@vcu.edu