Investigating Industry Involvement in Modern Clinical Trials

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In a study published earlier this month by JAMA, the authors aimed to discover how the pharmaceutical industry gets involved in the most influential modern clinical trials and how they fare in terms of transparency. Crediting the major impact of these clinical trials on medical practice, the authors believed that it was important to evaluate the extent of industry involvement and the use of transparency practices in such studies published in the last few years.¹

In order to find a sufficient answer, the study relied on a meta-research assessment consisting of 600 randomized and nonrandomized clinical trials published in 2019 or later. Trials that attracted the highest number of number of citations in Scopus as of December 2022 were selected for analysis, occurring from March to September of this year. Key points included industry involvement, transparency commitments, funding and conclusions, data sharing practices, COVID-19 trials, and improvement areas.¹

Results of the study are summarized below.

Transparency features:

• 79.8% provided a data availability statement, with 77.6% intending to share data.
• 18.2% of studies had data under embargo, and 7.5% would share data only after product approval.82.0% had a full protocol available, 74.3% had accessible statistical analysis plans, and 4.5% mentioned sharing the analysis code.¹

Factors associated with industry involvement and transparency:

1. Industry-funded trials were less likely to make data or code available but more likely to share protocols and analysis plans.
2. COVID-19 trials exhibited less exclusive funding from industry and less favorable results for industry-sponsored interventions.
3. Randomized trials were more likely to be analyzed by industry-affiliated analysts and had greater availability of protocols and analysis plans.
4. US-based trials were less likely to be solely funded by industry, less likely to have industry-affiliated authors, and less frequently analyzed by industry analysts.¹

Factors associated with industry involvement and transparency:

1. Industry-funded trials were less likely to make data or code available but more likely to share protocols and analysis plans.
2. COVID-19 trials exhibited less exclusive funding from industry and less favorable results for industry-sponsored interventions.
3. Randomized trials were more likely to be analyzed by industry-affiliated analysts and had greater availability of protocols and analysis plans.
4. US-based trials were less likely to be solely funded by industry, less likely to have industry-affiliated authors, and less frequently analyzed by industry analysts.¹

Factors associated with results favoring industry intervention:

Studies with favorable results for industry-sponsored interventions were more likely to be exclusively sponsored by the industry and have at least one author affiliated with the industry.¹

Recently, new guidelines have been put into place to help researchers ensure that their clinical trial protocols and reports are complete, high-quality, and transparent. According to an article by Medical Xpress, an international team of clinical trial experts has developed two guidance documents, both of which focus on early phase dose-finding clinical trials. These guidelines are a result of how clinical trials can be reported in various ways, limiting how useful they are to medical researchers and hindering medical progress.²

“Researchers from the Clinical Trials and Statistics Unit (ICR-CTSU) at The Institute of Cancer Research, London, led the DEFINE (DosE-FIndiNg Extensions) project in partnership with international experts,” wrote the authors of the article. “This collaborative effort was driven by a critical need for tailored guidance in early phase dose-finding trials, and it resulted in the creation of new checklists for research teams. Commonly referred to as Phase I trials, these studies are instrumental in providing information about how a new therapy interacts with the human body. Researchers use them to closely monitor potential side effects and determine safe and active dosages for the therapy under investigation.”

Despite these new regulations and findings, the authors of the JAMA study believe there are several areas that need improvement, further suggesting that they be discussed by diverse stakeholders, including industry, trialists, other funders, and institutions.¹

References

1. Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022. JAMA Network. November 14, 2023. Accessed November 22, 2023. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2811814

2. New clinical trial guidelines set to increase transparency and support progress in developing new therapies. Medicalxpress. October 20, 2023. Accessed November 22, 2023. https://medicalxpress.com/news/2023-10-clinical-trial-guidelines-transparency-therapies.html