Mary Kay Sobcinski, RN, MHA, Senior Principal Clinical Advisor, Clinical Sciences
Clinicaltrials.gov serves the public by providing important information about clinical trials and helps people find trials for a specific medical condition. For a number of years, medical device companies have been required to post most of their studies on clinicaltrials.gov but there are probably a few lesser-known requirements about the website you might not know. This blog will give you a quick overview of some of these considerations.
FDA requires that a “responsible party” be designated by the sponsor as the study registrar. The registrar must post an applicable clinical trial not later than 21 calendar days after enrolling the first human subject, so it is important to designate the registrar and obtain all internal approvals of the posting information well in advance of the registration deadline.
While US federal law requires that most studies be registered on clinicaltrials.gov, it is usually in the sponsor’s best interest to register all of its studies, as the International Committee of Medical Journal Editors (ICMJE) requires trial registration (before first patient enrollment) as a condition of the publication of research results generated by a clinical trial. In other words, even if a study isn’t required by law to be posted, the results cannot be published in most medical journals without it. Studies funded by National Institutes of Health (NIH) are also required to be posted. Feasibility studies usually fall outside the mandatory posting requirement but because publishing the results provides important information for regulators, adopting clinicians, and reimbursement entities, many sponsors elect to post their feasibility studies. However, for studies that are not required to be posted and if the sponsor does not plan to publish the results, the sponsor should weigh the benefits of providing study information against the risks of disclosing to competitors.
In other words, if the sponsor has a study (i.e., feasibility and is not planning to publish), registration is optional and the sponsor may choose to not register it so as to protect its product strategy and progress from competitors. While it wasn’t intended to be helpful to sponsors per se, the website offers sponsors an opportunity to see competitor information and draw from their postings to inform study designs as well as to find potential investigators and sites.
Posting Results and Key Study Documents
For studies that have a primary completion date on or after January 18, 2017, it is now required that the results be posted within one year of the primary completion date (date the primary endpoint is collected for all subjects). In addition, sponsors are required to upload the study’s protocol and statistical analysis plan (SAP). FDA will compare the posted results to the protocol and SAP for consistency and may respond with questions regarding discrepancies or seek clarification on confusing points. It is not always easy to understand the Agency’s comments and questions, so carefully review them to ensure your responses are accurate, complete and consistent throughout the posting and in agreement with your regulatory submissions. Of note, there is a provision that permits sponsors to formally delay posting results from trials for unapproved or uncleared device products until the device product is approved or cleared.
For those studies funded by adhering departments of the federal government, such as the National Institutes of Health (NIH), one version of the informed consent form used to enroll participants must be posted on a publicly available federal website, i.e., clinicaltrials.gov. The form must be posted after recruitment closes, and no later than 60 days after the last study visit. This requirement is for studies that received Institutional Review Board approval on or after January 21, 2019.and is defined in the newly
Adverse events must also be posted in a 3-table format:
- Summarize all serious adverse events;
- Summarize other adverse events that occur with a frequency of ≥ 5% in any arm of the clinical trial; and
- Summarize all-cause mortality data by arm or group.
The adverse event tables must include information about events that occurred, regardless of whether they were anticipated or unanticipated, the time frame for adverse event data collection and specify whether the collection approach for adverse events was systematic or non-systematic.
FDA’s Bioresearch Monitoring Program (BIMO) has directed its field personnel to inspect activities related to clinicaltrials.gov reporting by sponsors or responsibility parties. It is now required that sponsors include clinicaltrials.gov processes in their standard operating procedures (SOPs) and ensure that they have an adequate SOP in place before the next BIMO inspection.
FINAL ADVICE FOR CLINICALTRIALS.GOV
Clinicaltrials.gov serves an important role in ensuring public access to critical clinical research. While there are many requirements related to sponsor posting on the website, and compliance continues to be increasingly important and scrutinized, the tips presented here will help sponsors be aware of important deadlines and help assure compliance with evovling requirements.
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