Legislation requiring plain language summaries may increase trust in pharma industry

Global adoption of a European Union regulation may improve the public image of and sentiment toward the pharmaceutical industry, according to research presented at the American Society of Clinical Psychopharmacology Annual Meeting.

“[This research sought to address] the need to reverse the sustained-over-many-years trend toward an ever-worsening public opinion of the pharmaceutical industry in general and pharmaceutical clinical research in particular,” Charles S. Wilcox, PhD, MPA, MBA, of Praxis Research Consulting, told Healio Psychiatry. “The 2019 Gallup poll reporting that the pharmaceutical industry had hit ‘rock bottom,’ surpassing the oil industry in terms of public distrust, should be a huge wake-up call for all of us. Moreover, it also represents a compelling opportunity to reverse public sentiment toward embracing the importance of clinical research, in the context of the ongoing COVID-19 pandemic, as well as countless additional global medical needs.”

According to Wilcox, the EU passed the Clinical Trial Regulation requiring Layperson/Plain language Summaries (PLS) mandate in 2014. However, technical difficulties related to patient portals deferred mandatory implementation until this year. In the United States, numerous sponsors have evaluated projected costs and perceived benefits, as well as overall pros and cons, of a voluntary, proactive PLS strategy implementation. Despite these efforts, a comprehensive and/or quasi-standardized strategy is lacking for the creation and distribution processes for PLS, Wilcox said.

In his poster presentation, Wilcox outlined a history of PLS regulatory developments, from the authorization of direct-to-consumer pharmaceutical advertising in 1985 to the passing of the EU PLS mandate. Further, he highlighted the following operational costs and concerns that may accompany PLS implementation:

• significant direct and indirect costs associated with PLS processes for sponsors, contract research organizations and clinical research sites;

• compliance-related, strategic and regulatory costs and concerns, with direct cost quotes having ranged from $5,000 to more than $50,000; and

• an added level of involvement and costs regarding the potential role of for-profit institutional review boards.

Although legislation is in place in the U.S. related to the dissemination of study results within 12 months of study completion, their release does not require PLS. According to Wilcox, a voluntary, proactive embrace of PLS would offer several benefits, including bolstering trust with patients, subjects and participants; enhancing the pharmaceutical industry’s public image via better educating and informing participants; and encouraging future participation by providing evidence-based information.

“This is an unprecedented opportunity for our industry-at-large to proactively and voluntarily embrace the EU PLS mandate to our study volunteers, as we know they really do want to know what happened as a result of their participation,” Wilcox said. “Furthermore, with the ability to leverage and maximize current public sentiment regarding this current COVID-19-related positive attention toward clinical research, the provision of PLS is low-cost, low-hanging fruit. Finally, it’s just the right thing to do.” – by Joe Gramigna

Reference:

Wilcox C. Public image and sentiment toward the pharmaceutical industry: What can we do to reverse the negative trend? Presented at: American Society of Clinical Psychopharmacology Annual Meeting; May 29-30, 2020 (virtual meeting).

Disclosure: Wilcox reports no relevant financial disclosures.