Clinicaltrials.gov Joel Thompson, PhD COM Research Update 7.24.18

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

FDA vs NIH

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

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

Issues with CT.gov

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

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

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

Clinicaltrials.gov resources My contact info OSPA website Joel.Thompson@uky.edu 442 Bowmen Hall 859 323-2973 (corrected 7/25/2018) CT.gov Quick start guide CT.gov playbook CT.gov element connectivity Guidance for NIH trial dissemination

Important links University of Kentucky OSPA https://www.research2.uky.edu/office-sponsored-projects-administration Scroll through the “Quick Links” to the “Clinicaltrials.gov” tab NIH definition of a clinical trial https://grants.nih.gov/policy/clinical-trials/definition.htm FDA (FDAAA) definition of a clinical trial (flow chart) https://grants.nih.gov/ClinicalTrials_fdaaa/docs/Flow_chart- ACT_only.pdf