GUEST POST BY ALAN CASSELS

A University of British Columbia study published in the journal Clinical Therapeutics shows that drug companies that sponsor clinical trials in Canada can exert influence over whether the results of clinical trials are reported.

The study comprised interviews with 34 participants from Alberta, British Columbia, and Ontario, including 17 clinical trial investigators, one clinical research coordinator, three research administrators, 10 clinical trial participants and three ethics board members.

Trialists came from a variety of medical disciplines, including cardiovascular medicine, endocrinology, hepatology, infectious diseases, oncology, psychiatry, and rheumatology.

“There’s so much financial incentive for [companies] to report positive results and not to report negative results,” said one trial investigator.

Clearly negative studies are especially bad for the companies hoping to build an evidence base for their drug to eventually get Health Canada approval, so there is a lot at stake in how those studies are reported or published.

According to a previous systematic review, an estimated 40% of randomized controlled trials are not published in academic journals. While that may not seem so surprising, it is troublesome for both patients and doctors alike when trials with less favourable results for the tested drug are less likely to be published.

This phenomenon, known as publication bias, can lead to less informed patient care and harms to patients.

“Our study highlights a number of ways drug companies can influence whether trial results are reported,” said lead author Richard Morrow.

“It’s a problem that sometimes the agreements that researchers have with the companies do not fully protect the right of researchers to report trial findings.”

One trialist said he would only participate in research experiments in which an academic research organization shared full access to the study data, saying, “having shared access to the data is [one] way to protect against industry trying to . . . not get the information out there.”

The study also found that companies could stop a drug trial early and not report the results. According to a trialist involved in studies of cancer drugs, a small biotech firm faced with negative trial results might even shut down their company’s operations without completing an ongoing trial or publishing the trial’s findings.

In an accompanying article in Clinical Therapeutics, researchers Deborah Zarin and Harry Selker reflect on ongoing initiatives around the world to register trials so that there is a public record of basic information about each initiated clinical trial.  In the US, for example, regulatory requirements applying to many clinical trials demand that trial results be reported in the ClinicalTrials.gov registry within a year of completion of data collection on a study’s primary outcome.

Zarin and Selker contrast the US with Canada, which lacks this type of important policy to help ensure trial results are reported. The goal they assert is to “attain near-complete trial reporting.”

So what does this mean for patients who are asked to be part of a clinical trial?

Consumers who willingly engage in clinical trials should enter that trial with the expectation that ALL results—good or bad—will be properly reported. People contribute their time and energy to studies of drugs and there is an inherent responsibility that the researchers report whatever they find.

University officials can also do their part, and adopt a policy that fully protects the rights of academic investigators to report findings based on all data from a multicentre trial when an industry sponsor and trial leaders do not proceed to report the results in a timely way.

 

Interviews for the study were conducted between March 2019 and April 2021. None of the interviews related to COVID-19 trials.

The study was published in Clinical Therapeutics and is available online at https://authors.elsevier.com/a/1eh9SXyUrzNYA.

The journal’s accompanying editorial is available at https://www.clinicaltherapeutics.com/article/S0149-2918(22)00056-X/fulltext.

AUTHOR BIO: Alan Cassels is the Communications Director at the Therapeutics Initiative at UBC.