2013 CTSI Annual Pilot Awards to Improve the Conduct of Research

To facilitate the development, conduct or analysis of clinical & translational research

Tools and Infrastructure to Facilitate Compliance with ClinicalTrials.Gov Results Reporting

Proposal Status: 

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.


Great idea! Can you give more details on how you plan to do outreach to PIs of future trials, so as to lower noncompliance by about 75%?

yes.  sorry due to the 1 page length we couldn't put everything in there. 

we plan to work with CTSI Regulatory Knowledge Service and UCSF Office of Ethics and Compliance and UCSF ClinicalTrials.Gov Administrators to contact UCSF "Responsible Parties" (usually PIs) whose ClinicalTrials.Gov submissions (registrations of new trials and reporting results for completed trials) have errors.  We will also post information about this service on the UCSF HUB website. We will work together to identify how best to make this service known.  In addition we will work with UCSF representatives to UCOP policy groups on this issue to let other campuses know about the service.

great idea --I had little idea I remained in non-compliance. The cancer center should consider individual emails to alert PIs as none of my colleagues seem to reall this.

thanks.  I think the situation was exacerbated by the fact that previously many sponsors (eg NIH Institutes and Centers) were the "Responsible Party" and registered the trials.  Then when they realized how much effort is involved, they transfered responsibility to the PIs and that communication may not have included details on what is entailed. 

We all want to be compliant but don't always know how or even that we are not in compliance.  Just  this fall I had no idea I was (briefly) in non-compliance for not logging in to actively demonstrate that my ongoing registered trial still had the same status of recruiting participants - I didn't have to change anything in the registration, I just had to confirm there were no changes to become compliant.

If this works at UCSF, might we be able to disseminate it to the national CTSI consortium?

we can certainly disseminate the training materials and SAS macros.  in fact we already have made the first batch of SAS macros available on the UCSF HUB website: http://hub.ucsf.edu/basic-results-sas-macros

other aspects - most notably the 1-on-1 technical assistance - will not be very scalable but once UCSF and UC system needs are met, we could offer services for recharge for non-UC investigators.

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