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Study: Most Clinical Trials are Unjustified, Unethical

According the American Council on Science and Health, a new study suggests that the majority of clinical trials analyzed failed to meet criteria to be considered ethically justified.

What is a Clinical Trial?

A clinical trial involves researching human participants and is intended to add to medical knowledge.  Most clinical trials fall into two types of study:

  • Interventional studies
  • Observational studies

For interventional studies, participants receive specific interventions according to the research plan or protocol developed by the investigators. Interventions may be medical protocols (like drugs or devices) changes to behavior, changes to diet, or a medical procedure.

Results from the intervention group are then compared against a placebo or control group to gauge the interventions safety and efficacy.

What Makes a Clinical Trial Scientifically and Ethically Justified

There are not stringent guidelines when determining what criteria make a clinical trial justified. So the team responsible for the study created their own, very simple criteria:

  • Is there a specific hypothesis responding to a clear question? – The clinical trial should be hypothesis-driven, addressing a specific medical need. For example, Drug A should improve the lives of individuals suffering for Disease X. Trying to give participants Drug A to see is it does some random good does not meet this criteria.
  • Is there uncertainty around the central question? – There should be an unanswered question or questions about the efficacy of the intervention. If you already know the answer to the hypothesis being tested and have the evidence necessary to demonstrate that answer, there is no reason to have the study.
  • Has this uncertainty been established through a systematic review of the literature? – Scientists proposing the trial should have studied all available literature to know the potential of their intervention (such as Drug A above) and to ensure their questions have not been answered by another trial.

Findings of the Clinical Trial Study

The researchers applied the about criteria to more than 200 clinical trial and found that only 44% of the clinical trials met all three criteria.

Results for the individual criterion were as follows:

  • 76% of trials satisfied criterion 1
  • 99% of trials satisfied criterion 2
  • 54% of trials satisfied criterion 3

Contact an Experienced Clinical Trial Attorney

Thomas J. Henry Injury Attorneys are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry Injury Attorneys immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.

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