Biotech Values

[dangerM]

[general topic] Updates to Clinical Trial Information

Probably everybody here is using ClinicalTrials.gov for checking some specifics and the status of one trial or another.

Since beginning 2017 publishing results for new trials became mandatory**1, but also rules mandating timely updates **2.

What I wonder: if there's a design change that does not change the treatment of the individual patient - would this trigger a mandatory update? More specifically, would an increase of the patients to be enrollment trigger a mandatory update within 30 days? The way I read the relevant the FAQ**3, I'd say no.

Just from my experience, typically the companies communicate (or sneak that in somewhere else) much earlier before the bureaucracy to change any trial registry entry is finished. So usually ClinicalTrials.gov is nice to track the historical development, but does not replace watching company communications.



**1

The Final Rule clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain trials to ClinicalTrials.gov, in accordance with FDAAA 801. The Final Rule has been in effect since January 18, 2017.
https://clinicaltrials.gov/ct2/manage-recs/fdaaa

**2

https://clinicaltrials.gov/ct2/manage-recs/faq#updatesToCT

[This lists a table of triggers that mandate an update & the deadline for updating, usually calendar 30 days]

**3

https://clinicaltrials.gov/ct2/manage-recs/faq#fr_13

What are the requirements for updating clinical trial registration information when a Human Subjects Review Board approves a protocol amendment? The regulation at 42 CFR 11.64(a)(1)(ii)(O)) specifies for applicable clinical trials initiated on or after January 18, 2017, or for which registration information was voluntarily submitted pursuant to 42 CFR 11.60(c), that "f a protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial, updates to any relevant clinical trial registration information data elements must be submitted not later than 30 calendar days after the protocol amendment is approved by a human subjects protection review board." For determining the date by which the information must be updated, the preamble to 42 CFR Part 11 clarified that if there is more than one human subjects protection review board for a multi-site trial, the date of the first board approval for the amendment should be used. (81 FR 65110) This requirement applies to any human subjects protection review board and is not limited to amendments by human subjects protection review boards in the United States. Clinical trial registration information must include information for the entire study, because the entire clinical study is considered to be the applicable device or drug clinical trial. (81 FR 65013, 81 FR 65015)