We (preclinical) learn from the Big Brother (clinical). For example, they recognize the risks of bias in study design, conduct and analysis and we have discovered that it is relevant for us too. They introduced public pre-registration of studies and we start to realize that pre-registration can address many of the existing challenges faced by preclinical research. And so on.
However, we do not simply copy, but we rather learn and adopt because our solutions are often different and what is possible in clinical research may not be possible in the preclinical field and vice versa.
A few weeks ago Biogen has decided to withdraw a paper submitted to JAMA. That paper was and still is eagerly awaited by the research community because it analyzes results from the clinical trials of Biogen’s ill-famous anti-amyloid antibody drug called Aduhelm. According to some sources, the decision to withdraw was linked to JAMA’s request to revise the submission.
What do we learn from this example and why is it important?
First (and despite some deficiencies), peer review and the editorial process can and do work!
Second, when the Aduhelm paper is eventually published in some other journal, original JAMA reviewers may not remain silent and may disclose what exactly made Biogen uncomfortable. Trying multiple journals (submission-rejection-resubmission) is very common in preclinical research and, in the ideal future, an exchange and discussion forum (like the now-deceased PubMed Commons platform) could be a venue to share concerns that led to initial rejections but were not noticed in subsequent reviews.
Third, companies usually voluntarily publish (positive) outcomes of their clinical trials because such publications are then used in communication with the physicians expected to prescribe their drugs. We (preclinical) have no such argument and companies may treat preclinical discovery and development as part of their competitive knowledge not worth being shared.
The Biogen case is different though. Aduhelm has been approved for clinical use despite absence of evidence supporting its therapeutic efficacy. This is a unique case justifying a unique request: Would Biogen share all preclinical data supporting efficacy claims?