Education And Debate

How can research ethics committees protect patients better?

BMJ 2003; 326 doi: http://dx.doi.org/10.1136/bmj.326.7400.1199 (Published 29 May 2003) Cite this as: BMJ 2003;326:1199
  1. Silvio Garattini, director ([email protected])1,
  2. Vittorio Bertele, head of laboratory of regulatory policies1,
  3. Luca Li Bassi, consultant, laboratory of regulatory policies1
  1. 1 Mario Negri Institute, Via Eritrea 62, 20157 Milan, Italy
  1. Correspondence to: S Garattini
  • Accepted 15 May 2003

The duties of research ethics committees are becoming increasingly difficult—what skills and knowledge do their members need to evaluate protocols that contain elements that are not in the patient's interests?

Drug development and marketing has become a huge industry. The potentially enormous profits mean that to comply with their duty and act in the interest of patients and public health, research ethics committees have to carefully assess clinical protocols with the necessary scientific knowledge and evaluate the true objectives of new studies and the methods used.


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LIANE PAYNE

We have selected four main problems that such committees should examine critically.

The use of placebos

The latest revision of the Declaration of Helsinki has reinforced doubts about whether placebos are always used correctly.1 Using a placebo instead of a comparator drug is advantageous for the sponsor because the new drug has more chance of being superior, and this superiority can be shown with fewer patients and therefore with less expense. The use of a placebo can never be justified when a drug of proved efficacy is already available for a given therapeutic indication.

Some justify the use of placebo by stating that it can be used in addition to a comparator (a three arm trial) because the difference between the placebo and the comparator forms the basis for validating the result with the new drug.2 3 This can be challenged on several grounds. Firstly, it is not ethical to deprive patients of useful treatment even if the trial lasts only a few weeks. Secondly, three arm trials are not essential to validate results, as using a comparative trial of sufficient size would make false negative results unlikely. Thirdly, if the aim is to establish the usefulness of the new drug for patients, it is logical to test it on patients who are resistant …

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