The document presents a critique of the proposed rule for clinical trials registration and results submission, arguing that the regulations not only exceed statutory requirements but also impose unnecessary administrative burdens without commensurate benefits to users of ClinicalTrials.gov. The primary concerns highlighted include overly stringent and impractical timelines for results reporting and record updates, which are misaligned with the operational realities of academic research. The document emphasizes that increased and frequent reporting requirements divert valuable researcher time from conducting meaningful clinical work and impose significant costs on institutions and the public, all for limited improvement in transparency or utility for information seekers.
Recommendations include extending the results reporting deadline from 12 to 18 months, which the current statute permits, and standardizing update requirements by confining 30-day reporting windows to critical corrections or status changes while allowing other updates to follow a 12-month cycle. The document also opposes any unwarranted expansion of reporting scope—such as requiring lay summaries, technical summaries, or protocol uploads, or mandating reporting for unapproved products—arguing these changes would introduce significant new burdens without clear benefit. Highlighting recent Congressional and governmental calls to reduce regulatory burdens and facilitate research, the document concludes by advocating for a more streamlined, statutory-aligned regulatory approach that preserves essential oversight while enabling researchers to concentrate on advancing scientific knowledge and public health.
