Article: Friday, 31 January 2025
Pharmaceutical companies must disclose their clinical trial results in the interests of transparency, but it appears that competitive pressure can affect how they do his – and make them watch carefully what their competitors are doing. Some even race to make their disclosures earlier than competitors, edit their research objectives after the trials are completed, or support their disclosures with positively toned papers. These effects were found by Dr Chandrika Rathee, assistant professor at RSM and Dr Sumeet Malik from the University of Amsterdam, and Dr Rossella Salandra from the University of Bath when they researched how competitive pressures influence pharmaceutical companies’ reporting in their mandatory clinical trial disclosures.
Companies still have a lot of freedom in exactly how they make their mandatory disclosures, and they may do it in a way that adheres to the rules but still undermines the goals of openness. To find out more, the researchers focused on pharmaceutical firms that are required to publish clinical trial results on ClinicalTrials.gov, a platform for the results of clinical studies from around the world. They examined three key elements of disclosure:
While it’s assumed that transparency is guaranteed by mandatory disclosure laws and regulatory interventions, the researchers found that disclosure isn’t a consistent process, and there are factors affecting its operation. They identified three main factors and their effects:
When competing to create pharmaceuticals for the same disease or condition, companies release their trial data more quickly. They could be using this feat to signal their dominance to competitors.
Despite faster disclosure times, companies have been seen to alter their stated research objectives. This kind of action raises concerns about transparency.
Companies are more likely to accompany their disclosures with positively toned scientific papers, which can potentially skew public perceptions.
For business managers in pharmaceutical companies, the researchers recommend they pay attention to how the company typically responds to mandated disclosure regulations. “This is the route to understanding and identifying operational and reputational risks that come with non-compliance, or insufficient disclosure. Better anticipation of the potential risks means that strategies to mitigate them can be developed,” they say.
What’s more, understanding and addressing these reporting practices is essential for fostering genuine innovation and advancing scientific progress. Reporting biases can result in distortions in the development of new treatments – and this of course affects the overall quality and speed of healthcare innovation.
“Companies often learn from each other's research and development activities. The methods they use to conduct and report their R&D, including clinical trials, can significantly shape industry standards and practices. It is essential to understand the issues surrounding the reporting of clinical trial results, as these issues affect how firms interact with and make use of shared R&D information across the industry,” commented Dr Chandrika Rathee.
There are also industry-wide implications. The research highlights concerns about the effectiveness of current transparency mandates. Although companies comply with legal requirements, minor alterations to trial data and its presentation can obscure important findings. The study urges regulators and industry leaders to take these factors into account in future policy decisions to ensure that the public and healthcare professionals receive accurate and unbiased information.
For society as a whole, the findings are particularly relevant given the ongoing debates about delays in the publication of clinical trial data, selective reporting, and the broader implications for patient safety and research integrity. These mandatory disclosures are put in place to help patients find trials for which they might be eligible, improve the evidence base that informs clinical care, and build public trust in clinical research. The study highlights that regulators have to be aware of competitive pressures faced by companies that may hinder social welfare goals.
Timing, modifications, and tenor of firms' mandatory R&D disclosures: The role of competition, published in Research Policy January 2025.
Science Communication and Media Officer
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