Industry partners had a hand in designing, analyzing, and/or publishing most clinical trials they funded, researchers found, and this was not always disclosed in the final publications.

Among 200 phase III and phase IV trials of vaccines, drugs, and devices published in top-tier journals in 2014-2017 with full industry funding, there was no aspect -- design, conduct, analysis, or reporting -- for which academic authors were solely responsible in more than 30%, reported a team led by Kristine Rasmussen, PhD, of Rigshospitalet in Copenhagen online in the The BMJ.

For the great majority, some combination of industry personnel, contract research organization, and academic investigators were jointly responsible for these aspects of trial management and publication.

The study also included a survey sent to academic investigators listed as authors of papers appearing in the New England Journal of Medicine, The Lancet, JAMA, BMJ, Annals of Internal Medicine, and JAMA Internal Medicine. (The latter's editor, Rita Redberg, MD, was a co-author of the BMJ study.) The survey asked who contributed what to their studies; it was completed by 73, with partial responses from another seven.

One key finding was that respondents' recollections about their studies didn't always jibe with the published declarations of industry involvement. For example, 53 said their manuscripts were written solely by the academic authors, yet for 27 of those the published paper listed writing assistance from a contract research organization. The survey also turned up instances of the following:

Funder employees or contractors doing significant work without authorship

Undisclosed regulatory agency involvement in trial design

Undisclosed funder or contractor involvement in data analysis

Ultimately, only 4% of trials were independent in the sense that they were funded by industry without further involvement. In half of the trials analyzed, the lead author disclosed a tie to the funder outside of the submitted work.

But on the plus side, in no case did funders have full final say on a published manuscript, and most survey respondents said they benefited from the industry involvement.

"Conducting our study on academic and industry collaboration was not easy," said Rasmussen and senior study author Andreas Lundh, MD, MSc, PhD, of Odense University Hospital in Denmark, in an accompanying sidebar article.

"We quickly discovered that trial publications often lacked basic information about who conducted essential parts of the trial (such as the statistical analysis, for example). The role of the funder was often described in vague terms and sometimes we found contradictory information in the supplementary materials. We also found that, in some cases, what was described as an independent steering committee in fact involved employees of the industry funder."

Just one in three respondents reported that academics had the final say on trial design.

While respondents were mostly positive about the funder involvement, some reported having problems with the funder delaying publication and minor disagreements about trial design and reporting.

"From the survey, we learned that lead academics generally found collaboration with industry beneficial, both personally and for their institutions. They highlighted large industry grants, high impact journal publications, and recognition from their institution and colleagues as important benefits. It is easy to understand why some may accept having their academic freedom constrained," Rasmussen and Lundh said.

"Our clinical recommendations depend on clinical trials being reliable and conducted in the patients' best interests, without commercial considerations," the duo emphasized. "Independent trials are the way forward; the academic community should refuse collaboration where industry demands control over trial design, conduct, data, statistical analysis, or reporting."

Rasmussen and Lundh nonetheless cautioned that their survey yielded fairly few participants and that the study's findings may not be generalizable to trials in smaller journals.