The first U.S. case of the novel coronavirus was confirmed by the Washington State Department of Health on Jan. 21. A Seattle man in his 50s with underlying health conditions died on Feb. 29, marking the first reported death from COVID-19 in the United States.
And on March 16, Jennifer Haller of Seattle was the first person to be injected with the experimental coronavirus vaccine mRNA-1273 in a clinical trial. Haller, 43, works as an operations manager for a technology company. “We all feel so helpless. This is an amazing opportunity for me to do something,” Haller told The Associated Press, adding that her two teenagers “think it’s cool” she’s taking part in the study.
Scientists are calling this first-in-humans study a momentous occasion. Haller’s act of selflessness can be viewed as historic, considering that it took place during Women’s History Month.
When we think of clinical trials, we often think of participants as patients suffering from a specific condition. However, in this case Haller and other healthy volunteers age 18 to 55 were recruited for the clinical trial. The vaccine does not use any form of a live or weakened virus, so participants cannot contract the coronavirus from the vaccine.
If you or a loved one were unfortunate enough to contract COVID-19, you might not hesitate to join in a clinical trial. But what about those of us, like Jennifer Haller, who are healthy? The Department of Health and Human Services notes that sponsors often use healthy volunteers to test the safety of a drug in first-in-human trials. Sponsors test the efficacy of a product with patients in later-stage trials.
In a pandemic, the urgency of the situation may prompt more healthy people to participate. For other trials, however, sponsors often have difficulty recruiting healthy volunteers. Monetary incentives may entice some participants or, as in Heller’s case, the opportunity to advance medical research is sufficient incentive.
The vaccine given the COVID-19 trial participants was developed in record time, according to a National Public Radio report. A researcher associated with the trial explained that the technology starts with the digital information. “So we did not need to have the physical virus, just the information."
This points to the importance of transparency and data sharing in clinical trials. In the case of the coronavirus, industry stakeholders are banding together to combat the pandemic. One such example is the COVID-19 Healthcare Coalition, formed to support the rapid deployment of open source solutions addressing the COVID-19 virus. At TrialScope, we are doing our small part to help; we have launched CoronaClinicalTrials.com, a resource hub sharing vital COVID-19 trial information. We also are using social media to recognize individuals and organizations helping others during the pandemic. Look for CO-VIPs – and share – our #COVIP shout-outs on LinkedIn, Twitter and Facebook.
The whole world is awaiting results of this – and other – coronavirus trials. Unfortunately, for a vast majority of clinical trials, the participants never receive results in a format that is meaningful to them. According to statistics from the 2019 Center for Information and Study on Clinical Research Participation (CISCRP) Perceptions & Insights Study, 85% of respondents indicated it is important to receive a plain language summary on the results of the clinical research study. However, 61 percent of clinical trial participants did not receive any reports or updates on results after the study.
It’s one thing for the public to receive study results; it’s another thing for those results to be in a format that is easily understandable by non-professionals. For the general population to comprehend COVID-19 trial results – or any study results, for that matter – they must be written minus all the medicalese. Plain language summaries, also known as lay language summaries, are written to ensure that patients and caregivers can understand study results in order to make informed healthcare decisions.
Perhaps this pandemic will bring greater attention to the importance of clinical trial transparency. After all, there’s got to be a silver lining here somewhere.