Clinical trial sponsors fail to report results to participants, public

March 11, 2015

DURHAM, N.C. - Despite legal and ethical mandates for disclosure, results from most clinical trials of medical products are not reported promptly on a registry specifically created to make results of human studies publically available, according to Duke Medicine researchers.

Among all clinical trials of medical products, those funded by industry were the most likely to be publicly disclosed in a timely fashion, but even then, compliance was poor. Research funded by the National Institutes of Health and academic institutions lagged further, according to findings published by Duke Medicine researchers in the March 12, 2015, issue of the New England Journal of Medicine.

Study authors said the lack of transparency by industry, federal funders and academia has created a critical information gap about investigational drugs, devices and biologic therapies that not only hampers progress, but also violates obligations to patients.

"Patients who participate in clinical research have the expectation that the risk of participation will be offset by the creation of generalizable knowledge and the advancement of science, and that is achieved through the availability of clinical trial results," said lead author Monique Anderson, M.D., cardiologist and researcher at the Duke Clinical Research Institute. "Sponsors who lead clinical trials have an ethical and legal obligation to publically report their findings, whether the results are positive or negative.

In 2000, Congress authorized the creation of the ClinicalTrials.gov registry to provide information about clinical trials. Seven years later, the mandate expanded to require sponsors of most trials to begin registering and reporting basic summary results on the registry so the America public could have access to the resulting data.

The requirement covers non-phase-1 trials of drugs, medical devices, or biologics that had at least one U.S. research site. Trial results were to be reported by the sponsor within one year of completing data collection.

Anderson and colleagues found that in the first five years after the law's enactment, transparency has generally been poor among more than 13,000 clinical trials included in their analysis.

The Duke researchers examined studies from those listed on ClinicalTrials.gov, and found that an average of just 13.4 percent of eligible trials reported findings within the required one-year window.

For industry-sponsored trials, the rate was 17 percent. It was 5.7 percent for trials funded by academic or government sources other than the NIH and 8.1 percent for NIH-funded trials.

Compliance improved over time. At five years, 41.5 percent of industry-funded trials, 27.7 percent of academic/non-NIH-funded trials, and 38.9 percent of NIH-funded trials had reported results.

"The public, as well as health care providers, want 'open science,'" said Eric Peterson, M.D., executive director of the Duke Clinical Research Institute and co-author of the paper. "This study demonstrates that despite national laws, industry- and especially NIH-sponsored trials have a long way to go."

Among the studies in the analysis, nearly 85 percent were designed to investigate a new treatment, about 8 percent tested a prevention therapy, and the rest were for diagnostic tools. Two-thirds of the trials were funded by industry, followed by academic/non-NIH sources and the NIH.

"The law requiring public disclosure was enacted amid concerns that sponsors and investigators were selectively publishing trials that favored sponsors' interests," Anderson said. "Industry sponsors in particular were criticized for selective reporting. Since the law's enactment, many companies have developed disclosure policies and have actively pursued expanded public disclosure of data, but there may be a lack of knowledge about the law in academia, or a lack of resources to ensure timely reporting."

Anderson said penalties for failing to submit data within the one-year reporting period could be as high as $10,000 a day and/or the loss of NIH funding, but enforcement has not occurred, pending a rule approval.
-end-
In addition to Anderson and Peterson, study authors include Karen Chiswell; Asba Tasneem; James Topping; and Robert M. Califf (prior to his departure from Duke to join the Food and Drug Administration).

The Clinical Trials Transformation Initiative provided funding support, along with the National Institutes of Health Common Fund (3U54AT007748-02S1) and the Health Care Systems Research Collaboratory Coordinating Center via the National Institutes of Health (1U54AT007748-01, 3U54AT007748-02S1).

Duke University Medical Center

Related Clinical Trials Articles from Brightsurf:

Nearly 1 in 5 cancer patients less likely to enroll in clinical trials during pandemic
A significant portion of cancer patients may be less likely to enroll in a clinical trial due to the ongoing coronavirus pandemic.

COVID-19 clinical trials lack diversity
Despite disproportionately higher rates of COVID-19 infection, hospitalization and death among people of color, minority groups are significantly underrepresented in COVID-19 clinical trials.

Why we should trust registered clinical trials
In a time when we have to rely on clinical trials for COVID-19 drugs and vaccines, a new study brings good news about the credibility of registered clinical trials.

Inclusion of children in clinical trials of treatments for COVID-19
This Viewpoint discusses the exclusion of children from coronavirus disease 2019 (COVID-19) clinical trials and why that could harm treatment options for children.

Review evaluates how AI could boost the success of clinical trials
In a review publishing July 17, 2019 in the journal Trends in Pharmacological Sciences, researchers examined how artificial intelligence (AI) could affect drug development in the coming decade.

Kidney patients are neglected in clinical trials
The exclusion of patients with kidney diseases from clinical trials remains an unsolved problem that hinders optimal care of these patients.

Clinical trials beginning for possible preeclampsia treatment
For over 20 years, a team of researchers at Lund University has worked on developing a drug against preeclampsia -- a serious disorder which annually affects around 9 million pregnant women worldwide and is one of the main causes of death in both mothers and unborn babies.

Underenrollment in clinical trials: Patients not the problem
The authors of the study published this month in the Journal of Clinical Oncology investigated why many cancer clinical trials fail to enroll enough patients.

When designing clinical trials for huntington's disease, first ask the experts
Progress in understanding the genetic mutation responsible for Huntington's disease (HD) and at least some molecular underpinnings of the disease has resulted in a new era of clinical testing of potential treatments.

New ALS therapy in clinical trials
New research led by Washington University School of Medicine in St.

Read More: Clinical Trials News and Clinical Trials Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.