Clinical Trial Registration in USA

Introduction

Clinical trials play a crucial role in evaluating the safety and efficacy of new drugs or treatments. To ensure transparency and accessibility of trial information, registration of clinical trials on publicly available databases is mandatory. This article outlines the responsibilities of sponsors, the types of trials that require registration, the criteria for waivers, and the management of changes related to Investigational New Drug (IND) applications.

Responsibilities for Registration

The responsibility for registering a clinical trial lies with the sponsor unless a principal investigator is designated as the responsible party. Sponsors must ensure that their trials are appropriately registered to provide comprehensive information about the study to the public.

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Types of Trials

Requiring Registration Four criteria determine the trials that must be registered:

1. Interventional Study: Trials involving the administration of drugs or treatments to human subjects are considered interventional studies and require registration.
2. Falling under USFDA Regulations: Studies that fall within the regulatory purview of the United States Food and Drug Administration (USFDA) must be registered.
3. The phase of the Study: All clinical trials, except Phase 1 trials, are required to be registered. This includes Phase 2, Phase 3, and Phase 4 trials.
4. Exemptions: Observational studies and those not subject to USFDA regulations are exempt from registration requirements.

Voluntary Registration of Phase 1

Trials Although Phase 1 trials are not mandatory to register, sponsors have the option to voluntarily submit clinical trial information for Phase 1 trials. If a sponsor chooses to submit this information voluntarily, they are responsible for ensuring compliance with applicable regulations.

Timing of Information Recording

Sponsors should submit the required clinical trial information within 21 days of enrolling the first participant. Additionally, the results of the study should be submitted within 12 months after the study's completion date. The completion date refers to the date when the last subject was examined or received treatment for final data collection.

Managing Suspended Trials

If a trial is suspended without any participants involved, the overall recruitment status should be set to "withdraw." In such cases, no further results information needs to be submitted. However, if participants were enrolled but the trial was terminated after enrollment, the relevant category should be selected, and any available data should be provided.

Conclusion

Registering clinical trials on publicly accessible databases is vital for transparency and ensuring the availability of essential information to stakeholders. By adhering to the registration guidelines and fulfilling their responsibilities, sponsors contribute to the integrity and reliability of clinical research.

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