The pharmaceutical industry operates in a complex regulatory and competitive environment, where mandatory R&D disclosures are crucial for promoting transparency and public trust.

A recent study by CREI member Rossella Salandra, in collaboration with Chandrika Rathee (Rotterdam School of Management) and Sumeet Malik (Amsterdam Business School), focused on the US trial registry ClinicalTrials.gov, highlights the impact of competitive pressures on firms' adherence to these mandates.

Faster but modified disclosures

Competitive pressures shape not only the timing of disclosures but also their content and accompanying publications. When competition intensifies, pharmaceutical firms tend to accelerate their disclosure of R&D outcomes on the registry.

Yet, alongside this push for timeliness lies a more complex behaviour: modifying the content of the trial records even after trials have concluded.

While some of these changes are warranted, others might raise concerns about potential 'outcome switching' – a practice that can undermine transparency by selectively changing a study's key parameters, often to emphasise favourable results.

Implications for transparency and trust

Unlike previous studies focused primarily on voluntary R&D disclosures, this research underscores how firms navigate and adjust mandatory compliance under competitive stress. It highlights a dual nature: while firms disclose faster, they retain a degree of content control.

The study also connects to broader issues in scientific reporting. Modifications to trial objectives, whether by adding or redefining outcomes, can distort the true intent and results of medical studies. Such practices can raise concerns because altered disclosures can potentially mislead patients and other stakeholders. This can also impact medical decision-making and policy formation.

Policy and regulatory considerations

These findings call for a reassessment of transparency mandates such as the FDAAA 801 initiative for regulators like the Food and Drug Administration (FDA). Despite clear guidelines, compliance remains inconsistent.

Strengthening public accountability mechanisms, such as trial trackers that highlight disclosure failures, may help enforce timely and accurate reporting. Automating the pairing of clinical trials with their corresponding publications may also limit firms' ability to manipulate publication tenor.

Based on 'Timing, modifications, and tenor of firms' mandatory R&D disclosures: The role of competition', by Chandrika Rathee (Rotterdam School of Management, Sumeet Malik (Amsterdam Business School) and Rossella Salandra (University of Bath School of Management).