Two-thirds of clinical trials conducted at academic medical centers in the U.S. don't share their results publicly for at least two years after the study's completion, according to analysis cited by NPR.
Despite the nationwide drive to speed the science for cures to diseases, AMCs generally don't have a strong track record of sharing the results of their studies.
Along with his colleagues, Harlan M. Krumholz, MD, a medical professor at the Institute for Social and Policy Studies and the co-director of the Robert Wood Johnson Foundation Clinical Scholars Program, found clinical study results are often neither reported to ClinicalTrials.gov, the government website dedicated that purpose, nor published in a medical journal. Dr. Krumholz and his fellow researchers recently published their findings in The BMJ.
Using the Aggregate Analysis of ClincialTrials.gov database and manual review, Dr. Krumholz and his team identified all interventional clinical trials registered on the site with a primary completion date between October 2007 and September 2010 that had a lead investigator affiliated with an AMC.
Of the 4,347 interventional clinical trials identified across 51 AMCs, 2,892 (66 percent) of the trials' results were disseminated, with 1,560 (35.9 percent) achieving this within 24 months of the study's completion. The proportion of clinical trials with results circulated within 24 months of the study's completion ranged from 16.2 percent to 55.3 percent across AMCs. The share of clinical trials published within 24 months of study completion ranged from 10.8 percent to 40.3 percent across AMCs, whereas results reporting on ClinicalTrials.gov ranged from 1.6 percent to 40.7 percent.
"The failure to share results is so pervasive that it seems inappropriate to blame individuals," Dr. Krumholz wrote in NPR. "Instead, it is a systemic problem. Academic medicine has fostered a culture in which the sharing of our results is considered discretionary, rather than mandatory. And if researchers decide to pass on sharing, there is no consequence to them."
According to Dr. Krumholz, not reporting the results of clinical trials violates the fundamental principle of the scientific method, and is harmful to patients and society. It is also "dishonors" the volunteers who consented to the risks of participating in the studies.
The findings generated by clinical studies are meaningful; the fact that the studies were approved by the boards of leading academic institutions affirms this. Given this fact, "the holding back of the results impedes progress toward scientific breakthroughs, corrupts the medical literature and wastes research funding," Dr. Krumholz wrote.