The proposed rule would require the submission of all clinical trial results not later than one year after the completion date of the trial. Other potential changes include additional data elements that must be provided at the time of registration and results submission, as well as more rapid updating of ClinicalTrials.gov to ensure it’s accurate and up-to-date.
But the NIH takes into consideration some confidentiality issues by saying that results submissions can be delayed for as long as two additional years if the responsible party submits a certification to ClinicalTrials.gov that either: 1) a drug, biological product, or device studied in the clinical trial is not yet approved, licensed, or cleared for marketing by the FDA and is still under development by the manufacturer; or 2) that the manufacturer is the sponsor of the clinical trial and has sought or will seek within one year approval, licensure, or clearance for a new use of a product studied in the trial.
FDA Commissioner Margaret Hamburg said in a statement that the proposed rule “would help eliminate unnecessary duplicative trials, advance biomedical innovation, and provide the public with a much richer understanding about the clinical trials for these products.”
CRO Reaction
Although CROs (contract research organizations) won’t be impacted too broadly because the trial data is owned by sponsors, John Lewis, SVP of ACRO (Association of Clinical Research Organizations) told Outsourcing-Pharma.com that members “do have some concerns about the impact various transparency initiatives may have on operations, like ensuring informed consents properly disclose the potential availability of data and ensuring patient confidentiality.”
But he also added: “We are very excited, however, about the other piece of the proposed rule that focuses on making clinicaltrials.gov more useful for patient recruitment through increased registration of trials and more uniform data being reported.
“We also understand that the NIH/National Library of Medicine is working on a more user-friendly version of clinicaltrials.gov that will make searching for relevant trials much easier for patients and physicians. In the long run, we would like to see clinicaltrials.gov integrated into EHRs to increase awareness of available clinical trials and to facilitate patient recruitment.”