Applied Clinical Trials
Peter O’Donnell looks at efforts in Europe to improve R&D communication and trust with investors and the public.
Everyone knows that research and development is where the costs must be met in creating new medicines. And everyone knows that keeping the money flowing in to fund the research is crucial. Just look at the thousands of investors and company executives at the recent JP Morgan Healthcare Conference in San Francisco for proof of how vital money is. Or look at Pfizer’s new-year hesitations over keeping up its R&D into Alzheimer’s and Parkinson’s disease-that’s a neat demonstration of what happens when money-men decide there is too much risk, and too little return.
But bioscience companies in the UK who want to play their own tunes do not know enough about persuading investors to fund the piper. That, at any rate, is the conclusion to be drawn from a “Best practice guide for communicating R&D progress to investors and the public” published in early January by the industry’s energetic BioIndustry Association. The BIA describes it as a best practice guide for bioscience companies on how to maintain understanding and trust through their communications. It’s all about how to ensure that people outside the research community fully appreciate the value of putting money into research, of paying the piper so he can make the best music.
“We need investors and the public to be well informed and confident about the great science our companies are doing,” said BIA’s CEO, Steve Bates, launching the guide. The need for clear and effective communication has never been greater, he argues. “Distilling complex ideas in high science companies for multiple audiences can be challenging,” the guide says, introducing its advice for companies in planning their communications in an age of digital platforms and changing media.
And what does BIA see as the vital ingredients to affect this dramatic improvement in contacts between researchers and funders? Some of its recipe appears obvious to the point of dullness. Preparation of a regularly-updated communications plan focused on progress in a company’s product portfolio, scenario-planning in advance of trial results (including “how positive, negative, and mixed results will be communicated”), and approaching target audiences directly, rather than just through regulatory announcements. Consistency in the timing of communications, or clarity and transparency, even with bad news.
All fairly standard and predictable advice; but the guide offers some counsel about relevance that is genuinely pertinent. “Be mindful of the impact on members of the public to whom it (i.e., the information) is personally relevant,” it says. “Consider the effect the information may have on patients and their families, clinical trial participants, and others to whom it is personally relevant.”
This amounts to a timely reminder to everyone engaged in the medicines sector-investors, researchers, company bosses, regulators-to bear in mind the ultimate objective of their endeavors. Yes, each player is motivated by his or her own personal goals, be they related to profit, prestige, or career advancement. But if the end-users are completely neglected in that rationale, suspicions of cynicism are likely to arise, particularly in a sector whose public pronouncements frequently invoke the concept of service to the community. And at that point, erosion can set in of the trust that is such a crucial factor in the relationship between the public and healthcare systems.
As a case in point, the possibility has been under discussion in the UK recently of somehow protecting pharma from the impact of Brexit, by leaving drug approval under European control even when the UK is no longer a member of the EU. Not a bad idea, perhaps, but the mood music about it has focused on how valuable this would be for the drug industry. The proponents appear to have overlooked the very obvious consideration that if exceptions should be made to Brexit to aid the drug industry, then exceptions to Brexit might equally well be entertained for the benefit of patients. Leaving them out of the picture suggests self-interest rather than enlightenment.
Regulators, too, are not immune to the risks of misperception of motive. Some spirited exchanges in the European Parliament in early January exposed a persistent gulf of misunderstanding between the European Medicines Agency (EMA) and many patient groups, as critics unleashed a volley of accusations that the agency allowed undue drug industry influence over its decisions. Responding to concerns that agency experts were not sufficiently independent, Noël Wathion, the deputy director of the EMA, demanded: “What do you want? A system with no experts?” He scored a debating point, but his approach to the discussion served to strengthen, rather than dispel, the suspicions among many critics that regulators are aloof, immune to suggestions that alternatives might be considered.
Whether it’s innovators seeking sponsorship, industries seeking political support, or regulators seeking legitimacy, it’s dangerous to forget that the essential bottom line of every communication is that simple appeal: “Trust me.”
Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium