ArticleLearning health systems2018
The regulation of clinical research: What's love got to do with it?
Article in Learning health systems, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- The Need for Prospective Integrity Standards for the Use of Generative AI in Research.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2025Article
- Navigating the Informed Consent Process When Using Innovative Surgery.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2020Review
- The regulation of clinical research: What's love got to do with it?Learning health systems · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The central philosophical pillar of the current system of research regulation in the United States today is that clinical investigators cannot and should not be trusted to protect the interests of the people whom they recruit to participate in research. That distrust of researchers is coupled with a starry-eyed idealism about trustworthiness of clinicians. In my opinion, the distrust of researchers and the complacency about clinicians are both misplaced. The result of these twin errors is that people are overprotected in research studies and inadequately protected in clinical care. Patients outside of research studies are exposed to many types of risks from innovative therapy and from practice variation. Researchers who try to study these risks in a risk-reducing way are hampered by burdensome regulations. We need a fundamental theoretical and conceptual change. The change would require us to acknowledge 2 things. First, research can be done in a way that does not harm (and might help) current patients. Second, researchers as moral agents can balance their moral obligations to patients with their obligations to science just as clinicians balance their fiduciary obligations to patients with other interests.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.