Rationale: US law requires researchers to register clinical trials within 21 days of enrolling the first participant (since 27Sep2007) and to report clinical trial results in the ClinicalTrials.Gov (CT.gov) online system within 12 months of the last participant visit. Reporting results does not mean publishing in a peer reviewed journal, but rather entering information in CT.Gov’s standardized system. Noncompliance can result in the following for institutions and individual PIs: fines of up to $10,000 per day, withholding future federal research funding, preventing study publication, and/or public notice of noncompliance. Despite legal requirements and potential penalties, researchers still lag in mandatory reporting with only 22% compliance nationally (e.g. Prayle et al. BMJ 2012) and 73 UCSF trials campuswide currently overdue in reporting results. In 2012, the US Office of Management and Budget increased their investigator burden estimate to 41 hours for results reporting in CT.Gov. In short, compliance is hampered at least partly because CT.Gov is not an intuitive, user-friendly system.
Plan: The UCSF Dental Data Coordinating Center (DDCC) has already partnered with the CTSI Regulatory Knowledge and Support (RKS) Program, UCSF Office of Ethics and Compliance (OEC) to develop a set of 5 SAS macros to summarize trial results data in a format suitable for CT.Gov Simple Results tables (http://hub.ucsf.edu/basic-results-sas-macros). This funding would allow expanding those macros and developing other tools to meet the needs of UCSF investigators to comply with federal law. The CT.Gov system is frequently updated and expanded, so this support would allow the tools to stay current with both required and optional reporting elements. For example, one current macro allows 3 types of outcome measures: number (frequency), mean, or median; others such as geometric mean which CT.Gov allows will be added. By developing and refining training materials and consultation, staff supported under this funding mechanism will provide technical assistance to UCSF investigators to help them use these free tools to meet compliance requirements. Staff will also help troubleshoot the problems that UCSF CT.Gov Administrators identify. The UCSF DDCC will set up a recharge for these technical assistance and training services.
Criteria and metrics for success:
• Develop and disseminate additional training materials and tools to be posted on the ClinicalTrials.Gov webpage of the UCSF HUB website (http://hub.ucsf.edu/clinicaltrialsgov).
• Reduce the noncompliant UCSF trials from 73 to 19 (i.e. slightly more than 1 per week over 52 weeks).
• Establish a recharge mechanism to provide technical assistance and training to use results reporting tools.
Approximate cost and very brief justification ($50K max):
Most of the proposed budget of up to $50,000 (equivalent to just 5 days of possible federal fines) would be used to create a $48,000 fund from which the 73 current UCSF trials as well as future trials upon completion could draw to pay for technical assistance and advanced training in CT.Gov results reporting provided by the DDCC at rates similar to the CTSI biostatistics consultants. (With an assistance fund this size, 54 UCSF trials could receive an average of 8 hours of technical assistance to attain compliance. A smaller award would create a smaller assistance fund.) To make this project “shovel ready” prior to setting up a formal recharge mechanism, percent effort of staff will be allocated to the fund proportional to hours worked. The remaining $2000 will be used to facilitate setting up the recharge mechanism. Following this proposed CTSI grant, this service would remain as a sustainable service with a recharge mechanism and could serve other UC health science campuses (which are also struggling to comply with results reporting) and other institutions with CTSAs.
This proposed work is a collaboration between personnel affiliated with the UCSF DDCC and the CTSI RKS Program, UCSF OEC. Steven Gregorich, PhD statistician, is Director of the DDCC which coordinates 4 large prevention trials for three U54 cooperative agreements (UCSF, Boston University, and University of Colorado—Denver). Stuart Gansky, DrPH biostatistician, formerly directed the DDCC and now directs the UCSF U54 Center to Address Disparities in Children’s Oral Health (known as CAN DO). Marlene Berro, MS, RAC of the OEC, as the UCSF administrator for ClinicalTrials.Gov, maintains the list of records with problems. Nancy Cheng with master’s degrees in computer science and biostatistics has written SAS macros to produce Simple Results tables for ClinicalTrials.Gov. Elaine Cooperstein, MS, CCRP and Sarit Helman, MPH are clinical trials specialists with experience with SAS, OnCore and ClinicalTrials.Gov. Terri Sonoda is the budget analyst for CAN DO and the DDCC.
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