As stated by NIH director Francis S. Collins, MD, PhD, “access to more information about clinical trials is good for patients, the public and science…the final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”
Suggestions as to how researchers will overcome previous reporting barriers have centered on institution and industry-level incentives. Though investigators expressed reluctance to release results for fear of jeopardizing their chances of scientific journal publication, the risk has been addressed by the International Committee of Medical Journal Editors.
Another cause of these delinquencies has not, however, been addressed. The expansion of regulations will add to a practical challenge many institutions already face: strained resources.
Though the clinical research workforce in the US is its largest to date, so is the clinical trial portfolio. More than 228,000 privately and publically-funded trials are registered to ClinicalTrials.gov; this is over 9 times the number registered since the International Committee of Medical Journal Editors began requiring trial registration for journal publication (2005), and nearly 5 times the number since the FDAAA’s registration requirements were established (2007). Nearly 100,000 of these trials are registered in the US, more than in any other of the 192 registering countries. These numbers include recruiting and closed trials, as well as those with results already reported. To date, 22,948 trial results have been posted since the results database became available in 2008.9
The increasing complexity of trial design demands more oversight by clinical research staff, principle investigators, and regulatory agencies. Where data management is outsourced, miscommunications and database incompatibilities can lead to additional work in data monitoring and auditing, slowing the road to analysis. Staff turnover and training can also add delays and room for error.
Trial reporting, whether for ClinicalTrials.gov or publication, is also never limited to data supply. Concerted efforts by clinical researchers, principle investigators, and biostatisticians are required to produce results, often a difficult feat for journal publication alone.
On October 17th, the Cancer Moonshot Task Force (CMTF) issued a report of its 5 strategic goals. In its first year, the task force has worked in line with President Barack Obama’s commitment to precision medicine, by creating an open access resource for sharing cancer data via the National Cancer Institute (NCI)’s Genomic Data Commons (GDC).