Guest Author: Neal Meropol, MD
Timely (within 24 months of completion) reporting of the results of clinical trials in ClinicalTrials.gov is a federal mandate. Case Western Reserve University was found to be a top performer in a recent study of all clinical trials (not just cancer) listed on this site. Most centers have significant lapses in overall publication of trial results and in listing these results in ClinicalTrials.gov. In fact, lack of community benefit and data sharing from cancer research was called out by VP Biden in his cancer cure Moonshot report!
At the Case CCC, reporting of clinical trial results is coordinated by the Clinical Research Office, under the direction of Kat Karelus and Smitha Krishnamurthi, with project team April Firstencel and Jan Hanson. They collect data and cross-reference all publications of results by submitting it to the web site.
Until recently, little was known about investigator compliance with this federal regulation. A study led by Dr. Harlan Krumholz from Yale School of Medicine that was published two weeks ago in The BMJ (Ruijun C. et al. BMJ 2016; 352:i637) presented data showing compliance of leading academic medical centers in the U.S. with the requirements of reporting clinical trials results. CWRU ranked third among our peers in sharing our clinical trials outcomes.
Using data from ClinicalTrials.gov through the Aggregate Analysis of ClinicalTrials.gov database, the researchers identified 51 centers with at least 40 interventional trials registered in ClinicalTrials.gov and with primary completion dates from October 2007 to September 2010. The researchers looked at the proportion of trials that either published results in peer-reviewed journals or reported them in ClinicalTrials.gov within 24 months of study completion.
Overall, the results of 2892 (66.5%) of the trials had been disseminated (published or reported in ClinicalTrials.gov) as of July 2014, with the findings of 1560 trials (35.9%) disseminated within 24 months of completion. In 25.7% of cases, more than 24 months had elapsed from completion to dissemination. Across institutions, the proportion of trials that disseminated results (in ClinicalTrials.gov or published) within 24 months ranged from 16.2% to 55.3%. The rate for CWRU was 48.5 % which placed CWRU in the 3rd place out of 51 centers.
Kudos to all investigators who present and publish their clinical trials data, and to the Case CCC Clinical Research Office staff who work closely with investigators to assure accurate and prompt reporting of clinical trials results to comply with ethical obligations and statutory requirements to enable advances in cancer care!
Neal Meropol, MD is Associate Director for Clinical Research at the Case Comprehensive Cancer Center.