Why Transparency in reporting negative results is key for public trust

| by Tamsyn Frost

A recent perspective piece published in the New England Journal of Medicine highlights an issue that I have long felt reflects poorly on the industry, and that is public mistrust in ’Big Pharma’.

This issue has come to the fore with the race to bring a Covid-19 vaccine to market. While the authors talk about the highly politicised nature of the vaccine, with attempts by the US Federal Government to push forward a vaccine before the November presidential elections (even if the manufacturer has not requested approval), the issue of public trust is a very real concern. Indeed, distrust is only serving to further fuel the rising problem of anti-science rhetoric.

Public perception of the industry has grown more and more negative in recent years, with rising criticism over companies’ business practices and behaviours. There are very valid reasons for that distrust, which boil down to transparency. This lack of transparency is sadly apparent in how the industry reports and shares clinical trial data, particularly negative study results.

Companies are supposed to report the results of all their studies, but all too often companies won’t invest in developing reports that show the outcome of molecules that failed to meet clinical endpoints. As the legal representative for companies, IDEA Regulatory is supposed to help ensure that sponsors publish those results but we have had experiences where we have chased clients to report the data, in keeping with the regulations, to no avail. Until now, there has been nothing to force companies to follow through since, although the regulations require that they report clinical study outcomes, there is no onus or punishment if they don’t.

Recently, the FDA announced a change in policy with plans to introduce fines for companies that failed to report trial results. My hope is that EMA will follow suit.

There are so many reasons why clinical trial transparency is crucial. Aside from regaining public trust, such data can help to prevent other companies from spending time investigating the same or similar molecules, or can provide guidance on what manufacturing adaptations could be made to build a better product, based on the pharmacodynamic and pharmacokinetic data from the failed product.

Not repeating the same mistake is not only about helping other companies avoid similar mistakes; it’s also about patient safety. Every time you carry out first-in-man trials to determine safety and dosing you put your patient volunteers at risk. If data is available to demonstrate how, when and why a product failed, other companies could avoid initiating a programme that is doomed to fail.

As an industry, we learn from achievements, but we can learn even more from mistakes since if we know what went wrong, we won’t keep repeating the same error over and over. Clinical trial transparency is about improving science and information and ensuring we provide patients with safe, effective products.

As an industry, we must work together to overcome conspiracy theories and the troubling anti-science movement, and there is no better way to do that than to be ethical and open. When companies do anything that is unethical, underhand or secretive – whether it’s skipping some of the testing or hiding data – it will put those companies at greater risk when problems arise and harm the reputation of the industry as a whole.

Let’s work collectively to make sure we share data that can help to eliminate future unnecessary mistakes, and bring back trust to an industry that does vital and life-saving work.

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