STAT News published “The Placebo Response: A Hidden Risk to COVID-19 Trials” written by Tools4Patient authors on October 13, 2020. The article, authored by Erica Smith PhD, VP of Business Development and Dominique Demolle PhD, CEO, was published in STAT’s First Opinion column.
The article asserts that the success of the abundant drug development program for COVID-19 therapies and vaccines could be compromised by the placebo response, a substantial issue in the development of therapeutics in areas like pain and depression. In May, the FDA released a regulatory guidance on the development for drugs and biologics to treat or prevent COVID-19 that put the emphasis on evaluating COVID-19 symptoms – and not viral load – as a primary endpoint in clinical trials.
According to the article:
“As Covid-19 trials focus on clinical symptoms, they will rely on self-reporting of body aches, cough, shortness of breath, and the burden on everyday life. These endpoints are subjective, highly variable, and have been associated with significant placebo response rates. To illustrate, in pain trials, up to two-thirds of treatment efficacy has been attributed to the placebo response, and the rate is as high as 85% in trials for cough.”(1)
To further complicate this already complex issue, the profound public health need for – and widespread media attention on – the approval of effective measures to prevent and treat COVID-19 will likely increase clinical trial patient expectations of efficacy. As the placebo response is significantly influenced by expectation, this may actually increase the potential for high placebo response rates in these trials.
The full article in STAT is available here.
With this article, we urge scientists and clinicians to consider the placebo response when designing trials that evaluate COVID-19 symptom presence, duration, and severity as endpoints. Historical strategies to reduce placebo response-related data variability – including training patients to more accurately report symptoms and training clinical trial sites to avoid influencing subjects’ expectation – may not be feasible for COVID-19 trials. The dynamic nature of COVID-19 infection and need for quick enrolment of patients into clinical trials will likely not allow sufficient time for extensive patient and site training. Newer, more innovative methods – like Placebell – however, do have the potential to provide insight and reduce the impact of the placebo response in COVID-19 trials.
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1. STAT: The placebo response: a hidden risk to Covid-19 trials. Available at: www.statnews.com/2020/10/13/placebo-response-a-hidden-risk-to-covid-19-trials/?utm_content=buffer6c491&utm_medium=social&utm_source=linkedin&utm_campaign=linkedin_organic. Accessed October 13, 2020.