The CCTS Clinical Research Support Program updated a lunchtime crowd on the recent revision of the ClinicalTrials.gov website, which went live June 29, 2017, and how these changes are affecting investigators. An even newer version of the site went live Mon., Sept. 25, 2017, to improve usability based on research with end-users representing various stakeholder groups.
Below we highlight the key messages of the update:
- For studies that meet the definition of an Applicable Clinical Trial with a completion date of Jan. 18, 2017 or later, investigators must upload the full study protocol and statistical analysis plan as part of the submission of their results data. Full study protocol is defined as “including all amendments.” Results, protocol, and statistics analysis plan are all due within 1 year after primary completion of the study. [Editor's note: Bring your laptop and join us for one of our weekly Biostatistics, Epidemiology, and Research Design (BERD) Drop-in Clinics, if you need assistance developing a statistical analysis plan.]
- The Outcome Measure Section is “the biggest challenge for most, as it is very specific.” All major issues must be addressed and all records must be free of error messages in order to be released.
- A new checklist is available, but “there are many caveats—it is not exhaustive, is very FDA focused, and doesn’t address issues such as what if you want to publish?” It does help, however, in determining if your study qualifies as an applicable clinical trial according to the NIH definition (for more on the NIH effort to clarify this definition, see the Sept. 8 Open Mike post on the topic.
Future initiatives are aimed at increasing trust in potential participants of clinical trial as well as increase the transparency of individual data sharing.
- As of July 1, 2018, manuscripts submitted to journals following recommendations set forth by the International Committee of Medical Journal Editors (ICMJE) that report the results of clinical trials must contain a data sharing statement. Trials that begin enrolling on or after Jan. 1, 2019, must include a data sharing plan in the trial’s registration. McKenzie shared the experience of an investigator who failed to register before beginning recruitment, which led to the rejection of the manuscript submitted to an ICMJE journal.
- Other initiatives will focus on making informed consent and summaries of findings more plain language and increasing the integrity of study design. Currently, it is estimated that 31% or more studies switch outcomes when reporting, rather than report the findings associated with the original hypothesis of the study when registered.
For help in meeting the NIH requirements for clinical trial registration and reporting, email