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A Quarterly Published Journal of Isra University, Pakistan
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Status of Clinical Trials and Research Ethics in Pakistan
Waris Qidwai, Shahan Waheed, Ammad Fahim
Published on:
Journal Reference:
Volume 2 - Issue 2     May - August 2010
35 - 36
Download Abstract:

Clinical research, also called clinical investigation, is the method of testing new drugs or compounds in human subjects for the purpose of discovering potential beneficial effects and to determine their safety.1 Clinical research is now increasingly being outsourced by the multinational pharmaceutical industry.2 The business, which in 2002 was estimated to be a US $5-6 billion market, reached around $10 billion by the end of 2005 and is now expected to have reached US $ 20 billion by 2010.3 Because of the saturation in the American market, the trials are increasingly been shifted to Asian markets, particularly China, Japan, and India. Asia is attracting more business because of its huge population. Pakistan stands as the sixth most populous country in the world with its population of approximately 160 million. Being a developing country, the patient population in Pakistan is large.

Clinical trials are in their infancy in Pakistan; only 80 clinical trials have been registered. The growth, however, is encouraging. Pakistan can learn from the experiences of the U.S., Europe, Latin America, Japan, China, India, South Korea, Taiwan, Hong Kong, Malaysia, the Philippines, and Singapore to increase its share in the global clinical research business, which is currently negligible at 0.1 percent.

Pakistan has some 20 multinationals and more than 400 local companies.4 Of the 80 trials registered, 39 are recruiting, 12 are active but not recruiting, and 29 are listed as completed. The clinical areas involved in these trials include oncology (16 trials), infections (16), hypertension and ICH (13), blood disorders (5), central nervous system and psychiatry (4), metabolism and diabetes (3), and the remaining are in other fields. Clinical trial/research is a developing field in Pakistan and substantial investment can be attracted to this field, by making available the necessary platform and improving legal protection of intellectual property rights (IPRs), in particular providing protection to test data. Companies invest in countries where IPR protection is adequate. Jordan is one example where reforms to improve IPR laws in 2000 led to a substantial increase in the size of the pharmaceutical market; its exports have grown from about US $49 million to more than US $280 million. Before IP reforms, no international drug innovative company conducted clinical R&D in Jordan. Currently eight American and European companies are carrying on clinical R&D in Jordan. By 2004, medical tourism in Jordan had grown to about US $650 million; by 2005, medical tourism exceeded US $1.3 billion.3 There has been a debate for several decades about ethical considerations in conducting studies with humans. After several abusive trial situations, ethical considerations have become a prominent and critical part of clinical trials, both for safety and well-being of the subjects or volunteers enrolled in these studies, but also to achieve these goals based on sound scientific and ethical principles. Research ethics in Pakistan is an emerging field seeking to articulate the best ethical standards for research practices. Along with the optimism forgrowth in this industry, a concern that vulnerable populations may be exploited cannot be overlooked. According to Chandra Gulhati, editor of MIMS India: The commercial needs of countless, fiercely competing pharmaceutical companies has led them to depend on the tried and tested 3Cs: Convince if possible, confuse if necessary and corrupt if nothing else works.

There is a sense of crisis in the country about the effectiveness of the nationwide system that protects the rights and welfare of human research subjects. Trial participants should ideally read and understand their consent forms before they decide to sign them, but illiteracy and a lack of awareness limit this exercise. Informed consent sometimes does not exist, and when it does it is crude and inadequate. About 40% of patients surveyed in Pakistan believe that proper documentation of consent is either unnecessary or optional.2Aneed at the present time is for a strong centralized regulatory regime which can guide high quality development in ethical capacity with extra vigilance but an informed understanding of acceptable risk. Much is said about ethics but there is a scarcity of knowledge about its basics. Afew institutions have their independent ethics boards set up, but we find chaos in the government hospitals. Ethics and morality should transcend all social classes and all types of work places. The conduct of appropriate and ethical research in international settings has been the focus of recent international reports.5"7

Ethics Review Committees (ERC) are not a new phenomenon in Pakistan, and there is a gradual move within a few private healthcare institutions to initiate such committees.8 Approval by ERC or Institutional Review Boards is still not mandatory for obtaining research funding from local sources, but there is a dawning realization in the medical community that this step is now essential to attract and participate in collaborative research projects with institutions in the United States, the European Union, and international organizations such as the World Health Organization (WHO); it is a requirement for any publications in international indexed journals.9

Ethics Committees, ethical guidelines and norms, and independent review boards are all different ways of ensuring compliance with established ethical guidelines and good practices. Ethics committees cannot conduct their task responsibly unless there is sound knowledge about it throughout Pakistan. Evaluating conflict of interest and addressing cultural specificities in obtaining informed consent from vulnerable populations are some of the critical issues. Pakistan must do more to educate professionals at all levels, from technical staff to clinicians, in the concept of ethical research.