Introduction
Drugs and medications are used in the treatment of diseases and conditions in human beings, and so in the development of new drugs and medications there comes a phase, wherein these have to be tested in human subjects. The principles of Good Clinical Practice (GCP) come into focus at the time of conducting medical trials using human subjects. The purpose of the principles of GCP is to ensure that these trials remain with the required ethical standards and the results come from the scientific inquiry that upholds the standards of quality, irrespective of which part of the world these trials take place. Yet the principles of GCP are not the same worldwide. There are advantages and disadvantages in different countries implementing the principles of GCP in different ways.
Pros of Different Countries Implementing GCP Principles in Different Ways
The principles of GCP have evolved through the combination of the economic development and wealth available in the developed world on one side and through the prevalent culture in the developed world on the other side. Both these factors are non-existent in the developing world, which makes it difficult to conduct rigidly designed clinical studies in the developed world. Hospitals in the developing world may lack even the necessities and be overcome by the flood of patients they face.
Hayasake 2005, p.1401, points out that in Morocco cancer patients have to wait for days for a bed to fall free so that they can be admitted, and in India between 60-70% of patients fail to get hospital support, because of the deficiency in medical resources. In addition, the availability of trained staff for the conduct of the trial in a developing country will be limited. This suggests that outside assistance will be required, but experience has shown that trials conducted with assistance from outside seldom provide good results (Hayasake 2005).
By implementing the GCP principles in different ways it becomes possible to include the countries in the developed world in clinical trials. This is pertinent because many diseases are endemic to the developed world and in the case of other diseases the prevalence rate can be higher. Furthermore studying treatments of diseases in different environments gives better insight into the disease processes, and such studies in the developing world come at much lower costs than in the developed world (Hayasake 2005).
Failure to develop new drugs for the developing world test them for actual translation into use in the treatment of diseases would mean denying a very large segment of the population of the world, the benefits from the advances in science and technology. Implementing GCP principles in different ways removes this anomaly (The European Group on Ethics in Science and New Technologies, 2003).
Cons of Different Countries Implementing GCP Principles in Different Ways
A key element in the objective of the GCP is to maintain ethical standards in the conduct of clinical trials in any part of the world. This key element gets corrupted when the GCP principles are implemented in different ways, with particular concern in the poor adherence to the ethical standards prescribed by the GCP in trials conducted in the developing world (Nundy, Chir & Gulhati, 2005).
Examples of this poor adherence and consideration for human dignity abound in plenty. In India, there is growing concern over the conduct of illegal and unethical clinical trials, since India made it easier for international pharmaceutical companies to conduct clinical trials in 2005. India has about 14,000 general hospitals, but just about one percent has the infrastructure to conduct trials to meet compliance requirements of GCP, while the number of appropriate pathological laboratories is less than a dozen. This means that clinical trials will occur with poor adherence to GCP principles in many of the clinical trials as has been the case.
Two new chemical entities discovered in the United States of America termed M4 N and G4 N, were used in clinical trials at the Regional Cancer Centre in Kerala. Another illegal clinical trial was the formulation of vaginal pellets of erythromycin tried out as contraceptive agents in West Bengal. Yet another case is the trial of the cancer drug letrozole as an agent for the promotion of ovulation in women. These trials were all illegal and not in adherence to the GCP principles, as they took place without regulatory approval. Thus failure to implement GCP principles and the interpretation of the GCP principles arbitrarily in developing countries leads to corruption of the ethical standards required in the conduct of clinical trials (Nundy, Chir & Gulhati, 2005).
Literary References
Hayasake, E. 2005, ‘Approaches Vary for Clinical Trials in Developing Countries’, Journal of the National Cancer Institute, vol.97, no.19, pp. 1401-1403.
Nundy, S., Chir, M. & Gulhati, C. M. 2005, ‘A New Colonialism? — Conducting Clinical Trials in India’, New England Journal of Medicine, vol.352, n0.16, pp. 1633-1636.
The European Group on Ethics in Science and New Technologies. 2003, ‘Ethical Aspects of Clinical Research in Developing Countries’, Opinion of the European Group on Ethics in Science and New Technologies to the European Commission.