Randomisation ethics

The prerequisite for an ethical randomised control trial is that it provides no certain benefit to the individual patients and in fact could harm the child as the result of potential side effects. Research is justified when there is no convincing ground that any patient would be advantaged or disadvantaged if allocated to one treatment arm over the others (Freedman, 1987a). It has been shown that research participants often fail to understand that their treatment has been selected at random... 

Ethical issues and randomisation There are ethical issues with randomisation. There are two t)rpes of ethics which are associated with human, medical research - individual and collective ethics. Individual ethics recognises the primacy of the individual and is aimed at doing what is best for the subjects in the current trial. In contrast, collective ethics is aimed at doing what is best for all future patients who will benefit from the results of the current trial. Clearly, there is a tension between these two principles that is recognised in the declaration of Helsinki, which comes down on the side of the individual ... 

However, there is a counter argument. In the ECMO trial, after the result of the nineth patient became known the RPW design requires that the patients be randomised to ECMO compared to the standard ventilator in the ratio 9 1. Clayton argues that if the one treatment is so much superior to the other that 90% of patients are allocated to it, it is unethical to withhold it from the remaining 10%. If we accept that argument, is it also true if the ratio is 8 1 or 7 1 How much information is sufficient to make us, ethically, refuse to randomise patients Such questions are not simple. 

Palmer CR, Rosenberger WF. Ethics and practice alternative designs for phase III randomised clinical trials. Control Clin Trials 1999 20 172-86. 

Today, clinical trials must adhere to nationally and internationally agreed codes of good clinical practice, which define ethical and scientific standards. Good clinical trial design and conduct should apply scientific methods. Skilful analysis can never correct for poor design. The purpose of the trial should be defined and specific hypotheses stated in the written study protocol, which will also include details of how the trial will be conducted. Errors in the data have two components, purely random errors and systemic errors or bias, which are not a consequence of chance alone. Randomisation of subjects is important both to avoid observer bias and to prevent or minimise the influence of unknown factors that might influence the results. 

Therefore we provide a brief discussion of some relevant ethical aspects (and particularly of the randomised controlled trial). 

Marshall M, Lockwood A, Bradley C et al. Unpublished rating scales a major source of bias in randomised controlled trials of treatments for schizophrenia. Br J Psychiatry 2000 176 249-52 Pocock SJ. Clinical Trials A Practical Approach. Chichester John WUey, 1983 Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically Some suggestions for improving performance and accountabihty. BMJ 1996 313 1390-3... 

Edwards S B, Lifford R J, Braunholtz D A, et al. (1998). Ethical issues in the design and conduct of randomised controlled trial. Health Technol Assess 2 1-132. 

Clinical trial A formal study of a treatment conducted in patients with a specific disease indication. Such studies usually involve comparison with placebo or an alternative treatment and a randomisation process is used to determine the allocation of treatments. Ideally, they also involve blinding of patients and clinicians (i.e. they are double-blind ) to treatment allocations. Conducting a clinical trial involves intervening in patients treatments for research purposes and therefore informed consent from each patient and ethical committee approval are essential (see p. 31). 

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