ClinPage recently caught up with Miriam Shuchman, author of the New England Journal of Medicine’s recent analysis of the contract research organization (CRO) industry. Instead of rehashing the NEJM article from October, which still has the industry wincing, we asked Shuchman about the mood in academia.

She spoke from her office at the University of Toronto, where she’s an associate professor of psychiatry. Shuchman discussed peer-reviewed medical journals and “journalology.” The term was coined by science writer Jim Giles, writing in Nature. It refers to the study of studies, which has sprung up as medical journals have come to trust pharmaceutical companies less.

New Standards

Shuchman says the relationship between journals and those who conduct trials has always been a complex one, as one would have a hard time existing without the other. But in the past six or seven years, she added, the relationship has become “a dance,” with top journals setting more standards when it comes to what they will publish.

For example, study authors must disclose their relationships with study sponsors; and trials that aren’t registered won’t be published.

Bad Memories

“This is the journals saying, ‘We have a certain purpose for this industry, but we also have certain standards regarding rigor and transparency,’” says Shuchman, who authored “The Drug Trial,” a book about the Nancy Olivieri controversy at Apotex.

What might ease tensions in that relationship? Shuchman says the battles over the sponsor community’s disclosure of safety and efficacy data for Vioxx and Avandia have not been forgotten by journal editors. Healing might take time if it happens at all.

Requesting Transparency

“When an editor feels they’ve been misled by a company who sponsored a trial, that is not something an editor forgets,” Shuchman says. “So there may have to be a certain amount of time that passes without any such case. But I know that, right now, people still remember those cases very well. They still have editors of peer-reviewed journals very wary.”

What would help, she says, is greater transparency. “Right now, neither pharma nor CROs tend to be very transparent,” Shuchman says.

She added, “Recent regulations that have required greater transparency on the part of the pharmaceutical industry have been important. I think greater transparency on the part of the CRO industry would be a big step forward.”

Complex Landscape

And any possible political change after this year’s election is unlikely to affect the current climate, because the relationships between academia and big pharma are too far-reaching and nuanced.

“There are many aspects to the relationship between academia and pharma,” Shuchman says. “There are partnerships involving CROs and universities. There are collaborations involving CRO researchers and academic researchers. There are conflicts, and there’s competition between CROs and AROs [academic research organizations] for the business of running clinical trials. So the academia-CRO relationship is complicated, extensive and not easily characterized.”

When asked if the vibe between academia and the drug industry is darkening, Shuchman would only say, “We’re talking about so many multiple points of interaction. It’s nothing small we’re talking about.”

We did ask Shuchman one question that was related to her NEJM article: Given that thousands of clinical trials unfold annually with no controversial aspects whatsoever, was it fair to use half a dozen controversial trials as representative of what the CRO industry does?

Invisible Trials

Shuchman says the most-publicized and controversial trials were, ironically, the only ones it was possible to write about, given the CRO industry’s acknowledged preference and contractual need for secrecy.

“I can’t write about what I can’t learn about. As I wrote in my article, CROs tend to keep quiet, referring inquiries about CRO involvement in the thousands of clinical trials that unfold annually to ACRO [Association of Clinical Research Organizations].” Shuchman says she is not currently at work on a second book, but continues to write about health and medicine for medical journals.

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Editor’s note: Previous coverage of Shuchman’s NEJM article includes NEJM Indicts CROs and ACRO Responds to NEJM.