As acknowledged in the first remdesivir double-blind placebo-controlled clinical trial addressing treatment for COVID-19 recently published in Lancet (Wang, et al., April 29, 2020), a statistician at Rutgers Cancer Institute of New Jersey was called on to guard the integrity of that trial.
Weichung 'Joe' Shih, PhD, director of the Biometrics Shared Resource at Rutgers Cancer Institute and professor of biostatistics at Rutgers School of Public Health, was part of the Data Safety Monitoring Board (DSMB) for the globally watched trial. He shares more on the data assessment published in the May 16 online edition of Therapeutic Innovation & Regulatory Science.
Why is it important to guard the integrity of data such as this at this time?
Data integrity is an integral part of a clinical study at any time. It is particularly important at this time when there is much in the media almost every day on various treatments and vaccines being tested for COVID-19, and as people and decision makers globally tend to rush for something possible to save lives during this pandemic.
Remdesivir, which was the subject of this globally watched clinical trial for COVID, was deemed the first "hopeful" drug by the World Health Organization in early February when the trial started. In China, remdesivir has the nickname "people's hope" (resulting from its phonetic translation), which is interesting, yet reflects the desperateness of society.
How did you and your colleagues approach the data and what did you find?
My DSMB colleagues (from the US, UK, China, and Canada) and I understood the pressure of this urgent matter when called on to serve in the role of monitoring the remdesivir trial. We had to be able to transmit massive data quickly from the 10 participating hospital sites to the database, and analyze the data for detecting any signal (both efficacy and safety), all in real-time.
Fortunately, the DSMB had support of a dynamic trial monitoring computer system, that enters and verifies patents' electronic records and links to the organized database and an efficient data analytical system.
We found early on that remdesivir was not a "magic bullet" for severely ill patients of COVID-19. Its regimen was safe in the hospital setting. The timing of receiving the therapy, in terms of the patient's illness stage, was critical for the patient's benefit.
What is the takeaway message from your findings?
The first remdesivir trial on COVID-19 was a well-designed, carefully conducted and managed study despite the quick nature in which it was put forth and conducted. Our examination finds the data to be trustworthy. Since then, the US National Institute of Allergy and Infectious Diseases (NIAID) led a global trial of remdesivir with a larger number of COVID-19 patients (NEJM, Beigel, et al., May 22, 2020). The two trials found that among patients who were moderately severe, remdesivir improved time to clinical improvement.
Shi, W. J., Data Monitoring for the Chinese Clinical Trials of Remdesivir in Treating Patients with COVID-19 During the Pandemic Crisis. Therapeutic Innovation & Regulatory Science. doi.org/10.1007/s43441-020-00159-7.