Cancer Drug PRs May Mislead Clinicians and Patients

In oncology, positive outcomes from industry-sponsored clinical trials on solid tumors are frequently first announced via press releases (PRs) — often with limited detail — well in advance of peer-reviewed publication or regulatory approval.

This observation is part of a broader analysis conducted by an Italian research team led by Francesco Perrone, MD, PhD, current president of the Italian Association of Medical Oncology, and Massimo Di Maio, MD, PhD, the association’s president-elect. The study was published in Journal of Cancer Policy.

“Data communication often occurs through a PR to inform quickly and effectively a large number of readers through mass communication channels,” the authors wrote in the introduction.

Anna Amela Valsecchi, MD, study’s lead author and a researcher at the Department of Oncology, University of Turin in Turin, Italy, told Univadis Italy, a Medscape Network platform, that the team aimed to provide an updated, comprehensive snapshot of how these PRs are structured — specifically how often they report numerical data and how quickly they are followed by peer-reviewed publications or regulatory decisions.

Emphasis Over Evidence

The researchers analyzed 157 PRs related to clinical trials on solid tumors published between 2018 and 2022 by the top 20 pharmaceutical companies active in oncology. They found that 75.5% of the PRs claimed achievement of the trial’s primary endpoint. However, only 13% included specific quantitative results; most used vague or generalized language.

Despite the lack of detail, 86% of the releases asserted the clinical relevance of the findings. Yet, the median time from PR to conference presentation was 3.1 months, and to peer-reviewed publication, 8 months. Regulatory approvals followed even later: A median of 10 months after the PR for the US Food and Drug Administration, and 15.9 months for the European Medicines Agency.

Minimal Market Impact

The study also examined the market response to these PRs and found that their impact on stock performance was minimal or negligible. Valsecchi noted that this market caution could reflect the absence of concrete data or the understanding that information in PRs is often preliminary and not conclusive.

This portion of the analysis was conducted in collaboration with researchers from the Center for Research on Health and Social Care Management at Bocconi University in Milan, Italy.

Risks of Partial Communication

The findings of the Italian analysis highlight an important concern: The structure and content of pharmaceutical PRs can have meaningful effects on a broad audience, including physicians, patients, and caregivers.

“The absence of complete and detailed data makes it difficult for physicians to properly assess the clinical relevance and statistical significance of the reported outcomes,” said Valsecchi. “For patients, this can foster unrealistic expectations, and in some cases, lead to mistrust in the doctor-patient relationship when the information in the PR does not align with the physician’s clinical judgment or prescribed course of action.”

Valsecchi acknowledged the challenge of communicating complex medical findings to an audience that includes both healthcare professionals and the general public.

She also emphasized a broader issue: The lack of standardized guidelines for structuring PRs. This allows companies to highlight preliminary or incomplete results in ways that may unduly influence both the scientific community and patients. “Guidelines developed by a multidisciplinary working group could help ensure that PRs prioritize scientific rigor and patient protection, rather than being overly promotional,” she concluded.

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