The article, published by STAT on November 28, 2023, highlights the challenges faced by investors, analysts, doctors, and patients in interpreting clinical trial results from biotech companies. In response to the complexity of data, STAT has released an updated version of its “Guide to Interpreting Clinical Trial Results,” originally authored in 2020 by Adam Feuerstein and the late Sharon Begley.
The 2023 update provides new examples illustrating terms, metrics, and red flags to help readers navigate through company readouts. Clinical trials expert and physician Frank David, in the introduction, emphasizes the enduring relevance of the guide’s lessons and advice.
Adam Feuerstein, the sole contributor to the update, discusses the prevalence of “spin” in presenting clinical trial results. Spin, the practice of presenting negative results in a more favorable light, remains a constant challenge in the industry. Companies often employ tactics such as post hoc subgroup analyses to salvage negative studies, despite their limited success. Additionally, some companies attempt to manipulate perceptions by selectively disclosing study results or omitting relevant information.
Feuerstein highlights a recent egregious example where a company claimed its experimental drug improved cognitive decline in Alzheimer’s patients, but closer examination revealed that a majority of the study participants did not even have Alzheimer’s. This incident underscores the importance of scrutinizing not only the presented information but also what is left undisclosed.
The article also touches on the evolving landscape of study designs. While controlled trials with randomized and blinded patients are considered the gold standard, some situations, such as rare, life-threatening diseases, may necessitate single-arm studies. The FDA’s increasing preference for hybrid studies, combining response rate data with more stringent survival data, reflects efforts to enhance the assessment of drug benefits.
The 2023 update allowed Feuerstein to revisit the original guide and reflect on his collaboration with Sharon Begley. The guide, born from a webinar in 2018, was a collaborative effort that benefited from Begley’s extensive knowledge and teaching prowess. Revisiting the guide after her passing provided an opportunity to appreciate her timeless contributions, with little need for revisions. Feuerstein fondly remembers working with Begley and acknowledges her lasting impact on the STAT family.