Ethics in clinical trials

The topic of ethics in clinical trials is addressed again in Section 3.16.1, where we talk about ethical considerations in choosing the nature of the control treatment used in trials involving investigational antihypertensive drugs. 

The relationship between hypothesis testing and ethics in clinical trials... 

Kadane J (1996) Bayesian Methods and Ethics in Clinical Trials Design. John Wiley Sons, Inc., New York... 

The number of partidpants must be chosen so that the trial wUl have suflEdent statistical power , particularly in the case of confirmatory trials. As a general prindple, the greater the number of data, the greater the confidence there is in demonstrating that a statistical difierence between two groups exists, or not. However, numbers of participants will be constrained by cost considerations, the availability of suitable subjects and, above all, by the ethical prindple that subjects should not be enrolled in clinical trial unless they add scientific value. 

Guidelines V 7 N/A Yes, procedures of committee of medical ethics for clinical trials Yes, set up by the Research Committee of the Ministry of Health V V 9 Yes, norms and regulation of research in clinical pharmacology No, applications are sent to external experts for evaluation... 

NR Cutler, JJ Sramek. Scientific and ethical concerns in clinical trials in Alzheimer s patients the bridging study. Eur J Clin Pharmacol 48 421-428, 1995. 

The review of clinical drug trials by IRBs raises a number of interesting and difficult issues. These relate to the origin and sponsor of the proposed trial, the nature of the institution the IRB serves, and the manner in which the norms for determining ethical conduct in clinical trials can be applied to specific trials. 

The basic ethical questions raised by clinical research should never be underestimated. The pharmaceutical physician will need to be aware that failure, intentionally or because of misguided enthusiasm, to protect the health and well-being of each study subject can have very serious consequences. In an age where the medical profession is constantly under scrutiny, the drug industry is heavily criticised and the communication industry extremely active, mistakes in clinical trials are pimished. Therefore, before a study is commenced, a review should be made that the scientific approach is current, the motivation is clear, the processes are imambiguous, and there should be sufficient data to judge the safety and effectiveness of the interventions proposed. 

The second approach is to recruit participants, who must provide informed consent to take part in clinical trials of medications, through advertisements in newspapers or other media. This is a reasonable alternative to facilitating clinical trials that meet scientific and ethical standards, but one that has just begun to be used among adults. 

A basic ethical issue in several areas of psychiatric research is whether participants are able to provide informed consent, particularly for protocols entailing medication washout and/or placebo treatment. The majority of psychiatric patients who are asked to participate in clinical trials have adequate capacity to provide consent. Thus, in a study specifically designed to examine the capacity of schizophrenic patients to give informed consent, cognitive dysfunction and negative symptoms (apathy and avolition). but not psychotic symptoms (hallucinations, delusions), were found to be associated with impaired decisional capacity (Moser et al., 2002). These features are probably not unique to schizophrenia but are likely to apply to many other forms of illness. 

Given the ethical concerns about placebo-controlled study designs, several alternative procedures to reduce bias in clinical trials have been proposed ... 

Treating subjects in clinical trials in an ethical manner is of paramount importance. Several fundamental ethical principles guide drug development research in clinical trials, including ... 

From the scientific perspective, an inappropriate study design is generally incapable of answering a research question, no matter how careful the subsequent methodology and analysis. Additionally, the perfect design will not provide optimum information if the research methodology is flawed or an inappropriate statistical analysis is conducted. From the ethical perspective, research subjects voluntarily take part in clinical trials with the understanding that their participation... 

While regulatory authorities monitor research to ensure it is conducted in accordance with relevant laws and universal principles, stakeholders also seek reassurance that companies consider any ethical concerns that emerge. In particular, this is a matter of being respectful of the integrity of people participating in clinical trials, animal welfare, and culturally founded objections to certain types of research. This condition is an obvious motivator for the adoption of alternative methods, such as biosimulation. 

The ethical use of placebos as the gold standard to establish efficacy and safety of new agents in clinical trials has recently come into question. In order to establish efficacy of antiretroviral therapy in decreasing placental transmission of HIV, the HIV-infected pregnant females in Thailand and Uganda received placebo therapy, despite the known efficacy of zidovudine in decreasing placental transfer. Concern regarding the use of placebos when effective antiretroviral therapies are... 

Within this context, clinical pharmacists face effective participation in the research environment. Protocol development and execution, adherence to GCP and ethical principles, together with the balance between revenues and expenses, draw a specific working scenario that requires additional education and training, and represents an emerging challenge for clinical pharmacists. Conceptually, pharmacists are responsible for the safe and effective use of all medications, and this is especially important for medications used in clinical trials. Different pharmacy associations have been pointed out and have defined how far drug development and its attendant activities are a core function of the pharmacy profession." " ... 

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