Senior Compliance Specialist University of Michigan, United States
Background: By law, researchers are required to report the results of certain kinds of clinical trials in ClinicalTrials.gov. However, many researchers are unfamiliar with the complex and time-consuming process for reporting results. Researchers can also face serious compliance actions for failure to report results correctly or timely, including fines.
Program
Description: Our program is a pilot ClinicalTrials.gov results-reporting workshop held via Zoom. During each workshop, we use a dummy record in the ClinicalTrials.gov TEST system to model how to build the data tables required for results reporting. Our team goes through all four results-reporting modules in the dummy ClinicalTrials.gov record, while workshop attendees follow along in their own study records and work on their results. Asking questions is encouraged, so all attendees can learn together. By the workshop’s end, the attendees should have built their results tables and started inputting data. After the workshop, ORA staff hold office hours via Zoom for attendees with questions. Our team has assessed the program’s success through workshop attendance, a post-workshop survey e-mailed to all attendees, the amount of time ORA staff spent assisting researchers with completing results reporting following the workshop, and the number of attendees who submitted their results timely.
Program
Assessment: Overall, the pilot workshop was successful. Attendance at the first workshop was 100%, and the survey responses were all positive. During the workshop, attendees were engaged and asked questions. Faculty researchers who attended also appreciated having protected time that they could devote to working in their results and asking questions.
One limitation noticed was the workshop was most successful for attendees whose results were due soonest. If results were not due for several weeks, then attendees often did not work further on the results after the workshop. As a result, these attendees did not retain much information from the workshop and required additional help from ORA staff. Some attendees also took action that made results reporting more difficult and created potential compliance issues with ClincialTrials.gov, requiring ORA staff to provide more direct assistance. Additionally, many researchers had members of their study team attend as delegates, meaning there was a disconnect between the information provided by ORA staff to the researcher.
Limitations: A limitation of this program was the small sample size of the attendees for the workshop. Only attendees whose results were due in the next 2-3 months were invited. The small sample size also meant we received fewer responses to the post-workshop survey that was sent to the attendees. At this time, the workshop has only been conducted once. A second is scheduled and a third will likely be held before the poster presentation.
Discussion: Our program will be modified to address the limitations and issues that arose during the pilot. This program could be implemented at other institutions like ours where researchers are responsible for entering their own results. The FDA and NIH have faced increasing pressure from third-party organizations to enforce the requirements for ClinicalTrials.gov, including issuing fines to researchers who submit results late. These organizations actively track ClinicalTrials.gov records and publish a running total of the amount in fines the federal government could claim if it enforced ClinicalTrials.gov requirements. Our program reduces this risk to researchers.
