1. Clinicaltrials.gov
Joel Thompson, PhD
COM Research Update

2. What is Clinicaltrials.gov
Investigator
Public
Clinical trials is a pubic registry of clinical trials taking place in the United States
Why register:
fulfill ethical obligations to participants
provide information to participants
reduce publication bias
35% of publicly funding trial data gets reported
Two part system

3. FDA vs NIH

4. FDA requirements
Registration is required for trials that meet the FDAAA 801 definition of an “Applicable Clinical Trial"
Include interventional studies of FDA-regulated drugs, biological products, or devices.
FDA exclusions:
Phase 1 drug trials, including studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes (see note)
Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices, where the primary outcome measure relates to feasibility and not to health outcomes (see note)
Trials that do not include drugs, biologics, or devices (such as behavioral interventions)
Non-interventional (observational) clinical research (such as cohort or case-control studies)
The FDA and NIH take slightly differing approaches to registry requirements
FDA: drug, device, biologic
Human, prospective, intervention, health related biomedical or behavioral outcome
Delayed reporting

5. NIH requirements
A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health- related biomedical or behavioral outcomes
Examples include:
drugs/small molecules/compounds; biologics;
devices;
procedures (e.g., surgical techniques);
delivery systems (e.g., telemedicine, face-to-face interviews);
strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits);
treatment strategies;
prevention strategies;
diagnostic strategies. (which may include placebo or other control)   
Registries must be complete within 21 days of consenting the first participant

6. Issues with CT.gov

7. Clinicaltrials.gov Common issues
Study Status
Must interact with your record at least once annually
Recruiting status and start/completion date
Recruiting status must be updated in the location section as well

8. Clinicaltrials.gov Common issues
Releasing the record
Every time a change is made in the study registry, the PI must release the record

9. Clinicaltrials.gov Common issues
Contacts
Central contact must be the most accessible person related to the study

10. Clinicaltrials.gov resources
My contact info
OSPA website
442 Bowmen Hall
(corrected 7/25/2018)
CT.gov Quick start guide
CT.gov playbook
CT.gov element connectivity
Guidance for NIH trial dissemination

11. Important links University of Kentucky OSPA
Scroll through the “Quick Links” to the “Clinicaltrials.gov” tab
NIH definition of a clinical trial
FDA (FDAAA) definition of a clinical trial (flow chart)
ACT_only.pdf