Professor Arthur L. Reingold, MD, is Division Head of Epidemiology at the University of California, Berkeley, School of Public Health. He has criticized the scientific validity of the PACE trial. He was also one of the 42 signatories of the Open letter to the Lancet calling for the PACE trial data to be independently reanalysed.
Criticism of the PACE trial
David Tuller detailed Arthur Reingold's criticism of the PACE trial in his report Trial by Error:
- "Arthur Reingold, the head of epidemiology at the University of California, Berkeley, School of Public Health (and a colleague of mine), has reviewed innumerable clinical trials and observational studies in his decades of work and research with state, national and international public health agencies. He said he had never before seen a case in which researchers themselves had disseminated, mid-trial, such testimonials and statements promoting therapies under investigation. The situation raised concerns about the overall integrity of the study findings, he said.
- Although specific interventions weren’t named, he added, the testimonials could still have biased responses in all of the arms toward the positive, or exerted some other unpredictable effect—especially since the primary outcomes were self-reported. (He’d also never seen a trial in which participants could be disabled enough for entry and “recovered” on an indicator simultaneously.)
- “Given the subjective nature of the primary outcomes, broadcasting testimonials from those who had received interventions under study would seem to violate a basic tenet of research design, and potentially introduce substantial reporting and information bias,” said Reingold. “I am hard-pressed to recall a precedent for such an approach in other therapeutic trials. Under the circumstances, an independent review of the trial conducted by experts not involved in the design or conduct of the study would seem to be very much in order.” "