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Making a Commitment to Transparency

Words by Michaila Byrne

The solemnly sworn pledge taken by pharmaceutical companies to share their clinical trial data has resounded throughout the industry for decades. The intention may be genuine and unanimous, but how far does this verbal commitment truly translate into action? It may be time for pharma to consider renewing their vows, so they are less akin to a well-meaning verbal sentiment and instead resemble a quantifiable benchmark, rooted in accountability and evidence. In truth, the word ‘transparency’ is frustratingly ambiguous and without a homogenous consensus, it is hard to gauge the true extent of progress. “If you don’t have a consistent expectation or harmonised definition, it is hard to implement transparency, but even harder to measure and benchmark progress. Without being able to benchmark, I think progress is slower,” explains Dr. Jennifer Miller, Founder, Bioethics International.

Pharma’s public commitment to data sharing is sincere, but beyond the verbal pledge of ‘I will’, the industry finds itself wading through a muddy morass without guidance. “The progress toward a more open science in clinical trial transparency has been slow but steady,” says Miller. Following this, a perceived lack of transparency undermines the confidence felt by healthcare professionals, researchers, and patients:“Ultimately, you need a trustworthy biotech and pharmaceutical sector if you don’t want things like vaccine hesitancy.”

With the explosion of big data, it is more important than ever that pharma sets ethical standards by publishing all clinical trial results. “If you don’t publish negative results, you get a false impression of the data around a particular intervention and of the efficacy of some treatments,” explains Dr. Nick Broughton, Founding Partner, Ethos Ethics and Compliance.

“Clinical trial results should be made available in lay language, understandable for non-scientific persons,” explains Sigrid Achenbach, Head of Clinical Trial Transparency, Bayer.

One of the more consequential risks of failing to publish is the squandering of time and money, resulting in clinical trial duplication. Not only is duplication wasteful, but it is potentially dangerous. “There have been cases where research participants have been exposed to active ingredients known to be harmful, but the results of the trial have never been published. People have got really hurt from that,” says Miller.

For a people-centric industry, it’s crucial that pharma prioritises patients. “It’s important for respecting the autonomy of the patient who has consented to a clinical research trial. People think that it’s going to add value, because that is what they are told when they consent. It’s not respecting the patients who contribute to a study if you’re not publishing the results and just abandoning it,” adds Broughton.

Implications for patient care aside, science builds on what has come before. Assembling knowledge in the public domain is imperative in steamrolling pharma’s shared goal. In 2015, Bioethics International identified this knowledge gap and created the ‘Good Pharma’ scorecard: a standardised means of assessing data sharing practices that annually ranks the ethical performance of pharma companies and encourages data sharing policies.

“We want doctors to practise evidence-based medicine. That’s a challenge if you don’t have all the evidence in the public space. First and foremost, we need the clinical trial data and results to be public, so physicians have the best information possible,” explains Miller, calling for an institutional commitment. “Most large pharma companies have generally made that commitment. It’s the medium and smaller ones that now need to.”

Pharma’s commitment to transparency is widespread and optimistic, but it requires converting into institution-wide action. For the benefit of patients, public health, and in the interest of long-term innovation, institutional commitment to clinical trial transparency is necessary for evidence-based medicine to become a reality.

If you don’t have a consistent expectation or harmonised definition, it is hard to implement transparency

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