Almost All Clinical Trials Must be Registered with Clinicaltrials.gov

Almost all clinical trial initiated after 18th January 2017 must be registered with clinicaltrials.gov. Last week, NIH released a short checklist with detailed explainer for sponsors to determine if their trials must be registered with clinicaltrials.gov. An excellent explainer answers several common questions from sponsors regarding registration. Several useful facts are clarified for example, a Phase 1/Phase 2 must be registered but a Phase 1 study does not need to be. This means that proof-of-concept studies must be registered. Similarly, even if the clinical trial involves sites outside the US, but is conducted under an IND or uses products exported from the US, must be registered. Clinical trials with diagnostic products must be registered as well since such trials are designed to measure the performance of the product. Clinical trials with over-the-counter products need not be registered but those with dietary supplements to evaluate their therapeutic or preventive effect for a disease must be registered. Phase 0 studies and BA/BE studies for generic drugs need not register as they are both considered equivalent to Phase 1 clinical trials. An interesting scenario is where a product is exported from the US to another country for clinical trials. Such trials may be conducted without an IND with the FDA, and may be conducted exclusively at non-US sites, but will be subject to registration with clinicaltrials.gov. Obviously, if the product is manufactured and tested outside the US, its trial is not expected to be registered with clinicaltrials.gov, however, many times sponsors do anyway register such trials. A sponsor can always chose to register non-applicable studies as is seen with several Phase 1 studies. The checklist is intended to help the sponsors determine applicability of clinicaltrials.gov registration only and does not need to be attached for registration. Although the registration rule was announced earlier this year, this checklist closes the loop on any misperceptions that may have existed.