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Up to 50% of Clinical Trials could be Difficult to Justify both Scientifically and Ethically, Study Finds

Posted January 15, 2018

Clinical trials, i.e., medical studies conducted on people, are commonly held to be justifiable if the participants give (informed) consent and receive treatment which medical professionals expect to confer an advantage.

Given these parameters, a variety of different studies which could definitively prove the beneficial or harmful nature of certain drugs or other medical procedures are never conducted, because depriving people of medical treatments known to be useful is unethical.

Furthermore, before conducting any clinical trial, researchers first have to demonstrate the biomedical feasibility of their proposed treatment modalities.

According to a new study, however, as many as half of clinical trials might be ethically unjustifiable and scientifically useless.

One of the reasons for that is the ambiguous nature of what constitutes a scientifically viable study – there are currently no clear guidelines or widely accepted criteria for all scientists to refer to.

New study published in the Journal of Clinical Epidemiology proposes three criteria for screening clinical trials. Image credit: Natural Cancer Institute via, CC0 Public Domain.

In order to prevent future violations of professional ethics and poorly justified use of funds allocated to medical research, the authors of the new study propose three distinct criteria:

  1. Clinical trials should be driven by hypotheses and respond to specific medical needs, rather than be based on a shotgun approach where different drugs and procedures are examined without any clear explanation as to why and how they could work;
  2. Clinical trials should only be conducted in case of uncertainty over specific types of medical interventions – research on treatments already shown to be ineffective should therefore be disqualified;
  3. Before commencing a clinical trial, uncertainty about the medical treatment in question should be demonstrated by conducting a systematic review of the available literature.

In view of these criteria, only 44% of the clinical trials published in the Journal of the American Medical Association and the New England Journal of Medicine in 2015 could be properly justified in terms of ethics and scientific expediency.

Despite two apparent limitations — namely, the fact that not all researchers are good writers capable of forcefully presenting their case, and the existence of promising treatments without enough data to conduct a meta-analysis — the adoption of these criteria could help to both save money and avoid unethical practices.


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