On Monday, April 20th, the NIH will hold a public meeting to discuss the expansion of ClinicalTrials.gov as required by the FDA Amendments Act of 2007. You can register to attend in person or watch via videocast. You can submit comments online to Docket No. NIH-2009-0002 as well.
The FDAAA requires responsible parties to submit “basic results” information for applicable clinical trials. Currently, this includes tabular data (submitted within 12 months of study completion) that describe participant flow, baseline characteristics of the patient population, outcome measures and statistical analysis, and adverse events. Narrative accounts are not permitted.
The FDAAA includes provisions to ensure that information submitted to the data bank is complete and accurate and not false, misleading, or promotional. The NIH and the Food and Drug Administration (FDA) are instructed to conduct a pilot quality control project to determine the “optimal method” of verifying that submitted results information is nonpromotional and not false or misleading in any particular way.
Oh sure, that will be a piece of cake. Challenge grant anyone?
So, what’s up for discussion? According to the Federal Register notice, it seems the conversation will focus on making publicly available clinical trial data more accessible to patients:
- Whether to require submission of results information for applicable clinical trials of drugs, biological products, and devices that are not approved …
- Whether narrative summaries of the clinical trial and its results can be included in the data bank without being misleading or promotional.
- What additional information, if any, that is written in nontechnical, understandable language for patients should be required to be submitted to the data bank or should be provided in the data bank to assist patients in understanding and interpreting the information available in the data bank.
- Whether to require submission of the full clinical trial protocol or only such information on the protocol as may be necessary to help evaluate the results of the trial.
- Procedures the agency might consider for quality control, with respect to completeness and content of clinical trial information, to help ensure that data elements are not false or misleading and are nonpromotional.
- Whether the clinical trial information required by the regulation should be required to be submitted for applicable clinical
trials for which “basic results” information is submitted before the effective date of the regulation.
- The appropriate timing and requirements for updates of clinical trial information and procedures for tracking such updates.
- The standard format for the submission of clinical trial information required by the regulation …
- A statement to accompany the entry for an applicable clinical trial when the primary and secondary outcome measures for such clinical trial are submitted as a “voluntary submission” …
- Other issues associated with Section 801 of the FDAAA that will inform rulemaking.
The importance of publicly posting clinical trial data has many benefits, such as countering the publication bias against negative results and identifying investigators involved with industry-funded studies. However, Writedit had not given a lot of thought to the ethical issues of returning research results to patients (logistical barriers abound), nor realized the extreme ideas being floated on the topic, until co-authoring a review of Disclosure Issues in Neuroscience Research. One hopes a sensible and feasible expansion of ClinicalTrials.gov will eliminate discussion of an ethical requirement to track down and provide individual research findings (including those with no clinical relevance, at least with current knowledge) to every research participant.