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Clinical trials form an integral part of the drug discovery process worldwide. Clinical trials are the set of practices required to certify a new drug molecule as safe and efficacious for the market. Medical research, in general, is a good thing and absolutely necessary to cure number of chronic diseases.
At present in India we have 40 million asthmatic patients, about 34 million diabetic patients, 8-10 million people with HIV, 8 million epileptic patients, 3 million cancer patients, more than 2 million cardiac-related deaths, 1.5 million people with Alzheimer’s disease; 15% of the population is hypertensive, and 1% suffers from schizophrenia1 In order to give best treatment to above diseases research on humans is both necessary and desirable. A clinical trial is defined as "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes2." Interventions include not only drugs but also cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.
A set of guidelines3 are already in place in India for the ethical conduct of studies to safeguard the interests of patients or volunteers participating in the study. Globalization of international clinical trials creates new questions regarding ethics in conduct of clinical trials in human subjects and conducting research on marginalized or oppressed populations. Research subjects’ have long been controversial, even after decades of debate, experience, and Regulation. In this review, this paper aims at discuss the International and National Laws on Clinical Trials, ethics in clinical research, next it reviewed some current controversies on clinical trials and concludes with a discussion we need more standards and Legislations for future medical research on human subjects.
Clinical Trials Practice in IndiaGlobal clinical research is exploring India. Yet, it is certainly not the West that is introducing clinical research to India. Two ancient scripts, Charaka Samhita (a textbook of medicine) and Sushruta Samhita (a textbook of surgery), compiled as early as 200 B.C. and 200 A. D. respectively, show India’s age-old proficiency in medical research. However, a lot has changed in the clinical research scenario since then4. Today, clinical trials are conducted through a regulated approach following certain guidelines laid down by the International Conference on Harmonization (ICH), which is spearheaded by U.S.A., Europe and Japan. There are number of laws governing clinical research in India.
Indian Acts/Orders related to Clinical Trials is:# Drugs and Cosmetics Act – 1940
# Medical Council of India Act – 1956, (amended in the year2002)
# Central Council for Indian Medicine Act – 1970
# Guidelines for Exchange of Biological Material (MOH order, 1997)
# Right to Information Act – 2005,
# The Biomedical Research on Human Subjects (regulation, control and safeguards) Bill - 2005
Even though we have number of legislations the important one for clinical trials is The Indian Council of Medical Research (ICMR) – 1947(amended in the year2002) , which was set up in order to foster a research culture in India, improve and develop infrastructure and foster community support. The Drugs and Cosmetics Act, The Medical Council of India (MCI) Act states that all clinical trials in India should follow the ICMR guidelines of 2000. The ICMR has a mechanism of review for its own institutions, and so do other government agencies. Every doctor is governed by the MCI Act. Any doctor doing wrong in a trial or in practice can be prosecuted and the hospital can be closed.
The MCI Act is very strong; the MCI has the power to take punitive measures. The Drugs Controller General of India (DCGI) is responsible for regulatory approvals of clinical trials in India. The DCGI’s office depends on external experts and other government agencies for advice. Additional permissions are required for the export of blood samples to foreign central laboratories.5 The ICMR has a Central Ethics Committee on Human Research (CECHR). This committee audits the functioning of this Institutional Ethics Committee (IEC). The recently amended Schedule Y of Drugs and Cosmetic Rules order the composition of the IEC as per the ICMR guidelines. The DCGI’s office in collaboration with WHO ICMR and many committed research professionals, has been conducting training programs for members of the Ethics Committees across the country.
Regulatory changes in India regarding clinical trials:Recently Schedule Y of the Drugs and Cosmetics Act -1940 was amended in the year 2005. Earlier, we required that all foreign drugs be retested at one phase below the highest phase of testing abroad. Now parallel global clinical trials have come. Schedule Y now permits concomitant phase 2 and phase 3 trials. India can become part of global trials. But even then phase 1 has to be repeated for safety. The advantage is that, if we become part of a global trial, a part of a global movement to develop drugs, we can demand an affordable price. For example if a new anti-malarial drug is developed by a multinational company, India is part of the global trial; India can have a claim on it. ICMR should not approve drugs which are not relevant to India.
India Advantage for clinical trials includes 6;• large numbers of people with a range of illnesses,
• relatively low costs, availability of trained human power and infrastructure,
• high enrolment rates (higher than in the West),
• good patient compliance/ retention, and
• an “increasingly accommodating regulatory environment”
As stated earlier India have people with the right diseases. They’re also ‘treatment naïve’ – they will not have been able to afford treatment – so they are ideal for testing new drugs. This situation made India as an international hub for clinical trials. Using the loopholes in the law the multinational companies are outsourcing clinical trials to India. A recent study reveals that outsourcing clinical trials to India may be ‘rash and risky’7. This opinion is drawn on the basis of concerns about timelines for regulatory approvals, deficiencies in the functioning of the ethics committees, and an unethical approach to the recruitment of illiterate and vulnerable Indian people to clinical trials. In order to control the above situation and make the clinical trials transparent the ICMR is maintaining a clinical trial registry in India
It is described in detail below:
Clinical Trial Registration in IndiaIn order to make clinical data and reports available to all, an online clinical registry has been initiated by the Indian Council of Medical Research (ICMR) for the registration of any interventional trial to ensure the following goals: 8
• Transparency and accountability of clinical research
• Internal validity of clinical trials
• To oversee the ethical conduct of clinical trials
• Reporting of results of clinical trials
The clinical trial registry of India (CTRI) is the online registry of prospective clinical trials in India. This is the initiative started by the National Institute of Medical Statistics (NIMS) of the Indian Council of Medical Research and is supported by the Department of Science and Technology (DST) and the World Health Organization (WHO).
CTRI will create a database of prospective clinical trials in India after their registration. The data and reports of these clinical trials and their status will be available to the public and professionals free of cost after formal registration on their website.9Currently, the registration of clinical trials is only voluntary and not mandatory. With increased awareness about this initiative and wide acceptance of the purpose of CT registration, it is likely that it may become mandatory in the future for initiation of clinical trials in India.
It has been affirmed that CT registration should be done before the actual enrollment of study subjects in the trial. The principal investigator or sponsor should share the responsibility of CT registration. In the case of multi-centric studies, the lead investigator or sponsor should ensure that the CT is registered. For the registration of a CT, it is essential to declare 20 items relevant to the CT as determined by the International Clinical Trial Registration Platform (ICTRP) of the World Health Organization (ICRTP-WHO). For registration with the CTRI, additional items related to the EC or IRB's permission and that of Director Controller General of India (DCGI) are included. At the end of a successful registration, each CT is assigned a unique WHO identification number called the Unique Trial Reference Number (UTRN).
Clinical Trials Practice in USAIn the United States, the clinical-trials procedure is an elaborate one10, conducted in a number of stages and contributing to the immense time, risk and expense of the drug development process. First, there is pre-clinical toxicological testing of a potential new drug molecule. This is usually performed on animals, in order to determine whether the molecule being tested is safe enough to put into a living system. The second stage is that of dosage studies, designed to come up with a metric for the dose of the drug to be administered.
Predictably, the efficacy of a drug increases with its dose, but so too does its toxicity; the aim is therefore to find an optimum range within which efficacy is maximized without too greatly compromising safety. If the drug is too toxic when tried on animals, the trial will not proceed any further, but if acceptable dose ranges can be determined, the third stage is a three-phase trial in humans. Phase 1 trials are conducted on a small number of healthy volunteers to test the drug’s basic safety, since drugs that seem safe in animals may still show adverse effects in humans. Phase 2, which serve as a bridge, involve larger, scaled-up efficacy and safety trials on as many as a few hundred subjects, who may be either patients or healthy individuals. Phase 3 involves large-scale randomized trials on several thousand people, usually patients suffering from the ailment for which the therapy has been developed. These trials are frequently coordinated across multiple centres, increasingly on a global scale.
The sponsors for trials are generally biotechnology or pharmaceutical companies, since drug development in the US and most other parts of the world is undertaken largely by the private sector. Universities and publicly funded laboratories play a major role in the early stages of discovery—the identification of potential lead molecules and the conduct of pre-clinical tests—but the institutional structure of drug development is such that they increasingly license promising molecules to corporations that take them through clinical trials. This means that the biomedical and experimental rationales for clinical trials are completely entwined with the market value these companies see in the drugs that eventually get developed, and the market risk that attends the drug development process. Because of complexity of Regulations in USA, number of multinational companies is coming India to conduct clinical trials on human subjects.
International Laws on Clinical Trials:There are many international instruments that confer and safeguard the rights of participants in clinical trials. Modern ethics in human research mainly emerged after World War II, when Nazi physicians used prisoners for inhumane 'experiments'. This resulted in the creation of the Nuremberg Code in 1947, which clearly stated voluntary consent as an absolute requirement for human subjects’ research11. As a result, it became almost impossible to conduct any clinical research in mentally impaired and other vulnerable groups. In 1964, the Declaration of Helsinki – proposed by the World Medical Association – changed some of the absolute rules of the Nuremberg code; for example, it allowed the use of surrogate consent in the case of individuals with impaired decision making 12. International Covenant on Civil and Political Rights (ICCPR) – 1966 (particularly Article 7 as it relates to consent for medical and scientific experiments) 13; the Council for International Organizations of Medical Sciences (CIOMS) international ethical guidelines -1993 (since revised) 14; and, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use – Good Clinical Practice: Consolidated Guidelines -199615. On a European level [EU], the EU has issued its directive on good practice in clinical trials16 and the Council of Europe has issued a Convention on Human Rights and Biomedicine on biomedical research17. Most recently, UNESCO has developed a Universal Declaration on Bioethics and Human Rights.18
The Nuremberg Code and the ICCPR do not seriously focusing on human rights in clinical trials. Neither document recognizes the distinction between therapeutic and non-therapeutic research. This fundamental deficiency is that they have largely been ignored by the medical profession. According to article 1 of the Nuremberg Code and Article 7 of ICCPR (both addressing consent) means consent would be necessary in all circumstances i.e. those who become unconscious due to an accident or disease or those who are mentally handicapped could not, if no standard treatment exists, be offered new therapeutic measures that might restore their health or save their lives. Such a rigid interpretation would mean that the respective provisions exclude many of those they were designed to protect. Furthermore, Article 7 of ICCPR is to be reads "No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation."
The Article prohibits experiments that violate the integrity of the person by cruel, undignified or inhuman treatment. Clinical research carried out in accordance with general principles would not violate this provision. Yet the right to health argument confounds this. Recently XVI International AIDS Conference in Toronto, UNAIDS presented an ethical argument as to why trial participants that seroconvert during a trial do not require access to effective treatment19. UNAIDS representatives considered these issues as ethical and not obligatory legal issues.
However, CIOMS guidelines make some reference to the Declaration of Helsinki and it is “the fundamental document in the field of ethics in biomedical research."20 The recent version also enunciates the laudable goal that "the research is responsive to the health needs and the priorities of the population or community in which it is to be carried out; and any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community."21 Nevertheless, as stated in the Declaration of Helsinki, human rights issues are coming to be seen as within the proper domain of public law and private law remedies such as negligence and the tort of trespass do not constitute a potent deterrent for unscrupulous researchers operating in under-developed countries where access to legal advice is scarce and/or prohibitively expensive. But in reality a strong civil law is helping effected people at the end of the trials.
Ethics in Clinical ResearchMost basic and complex principle of clinical research ethics is informed consent. An ethically valid informed consent has four key components: disclosure, understanding, voluntariness, and competence. This creates challenges for researchers in pediatrics, psychiatry, emergency and critical care medicine. One can take surrogate consent or waived consent in the following circumstances they are for example where a study of people at risk for Alzheimer's disease, more than 90% thought that surrogate consent was acceptable for minimal risk studies as well as randomized trials of new medications. Whereas in case of intensive care and surgery patients their consent is also informed consent, but in reality people are not aware of the fact that they are in clinical trials. This is revealed in number of studies.
However, it is important to recognize that if surrogate consent were eliminated, then it would virtually eliminate almost all critical care research because many critically ill patients are incompetent or unable to make a sound decision22. Family members are frequently unavailable, may not know the patient's wishes, or may not be specifically legally authorized to give consent for the patient's involvement in research. Therefore, some have questioned whether the concept of informed consent is even applicable to research involving the critically ill.23
For example in USA only certain emergency and resuscitation research can be done without prospective informed consent. This is based on the 1996 US Food and Drug Administration (FDA) 'Final Rule' and the US Department of Health and Human Services' parallel 'Waiver of Informed Consent' regulations. These require community consultation, public notification, and independent data and safety monitoring to allow exemption from informed consent 24
These regulations further stipulate that they can only be applied to emergency research for which human subjects can not give informed consent because of their life-threatening conditions (for example, unconsciousness); the condition requires immediate intervention; available treatments are unproven or unsatisfactory; clinical equipoise exists; the research might directly benefit the subject; the research intervention must be administered before informed consent from the subjects' legally authorized representative is feasible; and the responsible IRB concurs and documents that these conditions had been met. Other methods such as deferred consent, implied consent, or delayed consent are no longer deemed acceptable, despite previous use in early resuscitation research25. However, in the 10 years since the release of the Final Rule, investigators in the USA have reported variability in IRB interpretation, and have called for standardization and refinement of the rule. To address these concerns, as well as concerns from ethicists and other stakeholders, the FDA recently announced a public hearing on emergency research to be held on 11 October 2006. An updated FDA guidance document is expected following this hearing that is intended to assist IRBs, investigators, and sponsors in the development and conduct of emergency research using exception from informed consent.
Informed Consent situations in India:Experimental cancer drug tested without people's consent
In November 1999, 25 people with oral cancer who went to the government-run Regional Cancer Centre in Thiruvananthapuram were given an experimental drug, the chemical tetra-O-methyl nor-dihydro-guaiaretic acid (M4N) or tetraglycinyl nor-dihydro-guaiaretic acid (G4N), though there was an established treatment for their condition. They were not told that they were taking part in an experiment or that they were being denied an established treatment26. Only later did it become known that the trial had not been approved by the Drugs Controller of India (approval was obtained retroactively). Further, the sponsor institution, the Johns Hopkins University in the United States, had not given ethical clearance to the study, but managed to release the money for research anyway.
Diabetes drug tested on humans before toxicology studies completed.
In 2002, the multinational company Novo Nordisk conducted multi-centre phase III clinical trials of a diabetes drug before receiving the results of animal studies. The study report found that the drug, ragaglitazar, caused urinary bladder tumors in rats -- and this should have been known before the drug went for phase I trials, let alone phase II and phase III. Ragaglitazar was developed by Dr Reddy's Laboratories, Hyderabad, and licensed to Novo Nordisk which conducted the trials. The trials were conducted on 650 people from North America, 200 from Latin America, 100 from Australia / New Zealand, 800 from the European Union, and 200 from non EU Europe- -and 550 from Asia -- including 130 people from eight centers in India. Half of these people received the experimental drug.
Drug promotion as researchIn 2003, Mumbai-based Sun Pharmaceutical Industries Limited launched a promotional-cum-"research" programme by getting private doctors to prescribe the anti-cancer drug Letrozole to more than 400 women as a fertility drug for ovulation induction. They then publicized the doctors' reports to other doctors as "research", using their network of medical representatives. As a result Off-label prescription of drugs was banned in India, prompting the Indian Medical Association to launch a campaign to permit off-label prescription.
Research in emergency situationsIn 2003-2004 the drug company Santa Biotech ran a bioequivalence study testing its version of the "clot-buster" streptokinase against the established one. Streptokinase is given as emergency life-saving treatment to stroke patients. While there were various controversies about whether the company had taken the correct permissions to conduct the study, the important questions are: could the patients have given their consent to participate in the trial? After this In 2002, Dharmesh Vasava was among a number of daily wage workers who were given a psychiatric drug as part of a bioequivalence study sponsored by the Mumbai-based Sun Pharmaceuticals. He developed pneumonia and died. The People's Union of Civil Liberties, Vadodara, conducted an investigation into the death. PUCL suggested that the participants were unlikely to have been able to give their voluntary informed consent to participate. Second, was their health checked properly before entering the trial, and monitored closely during it? Incidentally, bioequivalence studies are conducted by drug exporters, to prove that their product is as effective as the approved branded version. They are not needed by Indian regulatory authorities.
These are the situations where the companies conduct clinical trails based on informed consent. All these things are happening in these days where media and communication are developed. Look at the situations in rural areas where people suffers allot to get good food and shelter. Number of multinationals is taking advantage of these situations for their business purposes. Now it is the duty of ICMR to control unauthorized clinical trials in India.
As the medical research world becomes increasing globalized, there is a need to make research both methodologically and culturally valid. Conducting research on human subjects stretches the current norms of medical ethics as well as stretching the current capabilities of international law. To rely simply upon minimum standards of non-binding and vague medical ethics instruments for conducting research on humans is both naïve and culturally insensitive. Human lives are inherently complex and no single ethical framework, including ours can claim to capture the complexity of research and understand the ethical dilemmas that arise in these diverse settings. In accordance with universal principals of justice, the "effective " participation of oppressed populations in decision-making will be an instrumental step in combating the social, economic and political forces of globalization that constrain human capabilities. A law will not guarantee anything – look at how the laws on transplants, on sex selection, are broken.
But having a law will help for those who are afraid of scrutiny, which are conscientious. The group misusing the law will do so anyway. But with a law you can ask questions, conduct an inquiry, and take action. To ensure that India becomes a leading nation in Good Clinical Research, greater attention must be paid to promoting clinical research. The gap between the developed and developing worlds needs to be narrowed in order to ensure global justice, particularly with respect to the widespread availability of proven interventions in developing countries. The emphasis is to ensure that Research ethics should be made an integral part of all biomedical research. As such every stakeholder should consider research participants as central players, who should be protected from any harm for which an appropriate legislation should be in place to ensure the above.
1. For details see: http://www.igatecorp. com/icri/html/aboutus/tia.htm last visited 22nd October10th 2008.
2. Gevers S (2001): Medical Research Involving Human Subjects: Towards an International Legal Framework? European Journal of Health Law pp 8:293-298.
3. For details see ICMR Guidelines – 2000.
4. Weijers C, LeBlanc G. (2006) “Revisiting the ethics of HIV prevention research in developing countries”. XVI International AIDS Conference 2006. Toronto. TUAE0302 August 16 2006.
5. Nundy S. and Gulhati CM (2005). “A New Colonialism? — Conducting Clinical Trials in India”. NEJM. April 21, 2005. No. 16, Volume 352: at pp1633-1636.
6. See: http://www.igatecorp. com/icri/html/aboutus/tia.htm Last visited 12th September,2008
7. Jayaraman KS (2004). “Outsourcing clinical trials to India rash and risky, critics warn”. Nat Med; Vol: 10, at p440.
8. World Health Organization, International Clinical Trials Registry Platform (ICTRP), List of Registers. [Cited 2007 10 Aug] Available from: http://www.who.int/ictrp/network/list_registers/en/index.html, Last visited October, 22nd 2008
9. See for details: www.ctri.in Last visited 12th September ,2008
10. Adriana Petryna(2005), ‘Ethical Variability: Drug Development and Globalizing Clinical Trials’, American Ethnologist, vol. 32, no. 2, pp. 183–97; and Petryna, ‘Drug Development and the Ethics of the Globalized Clinical Trial’, Princeton Institute for Advanced Study Occasional Paper 22 (Oct 2005).
11. See Tracy Lewis, Jerome Reichman and Anthony(2007) “So, The Case for Public Funding and Public Oversight of Clinical Trials”, The Economists’ Voice, vol. 4, no. 1 At p 234
12. According to a speech given by M. K. Bhan, director of the Department of Biotechnology, inaugurating the Bio Asia 2006 conference in Hyderabad, 9 February 2006. The day before, the Department’s budget had been increased by 25 per cent, indicating both the serious prioritization of biotech by the Indian government and that lack of resources is no longer the issue when it comes to certain types of science and technology in India.
13. Office of the High Commissioner for Human Rights: International Covenant on Civil and Political Rights. Adopted and opened for signature, ratification and accession by General Assembly resolution 2200A (XXI) of 16 December 1966 http://www.unhchr.ch/html/menu3/b/a_ccpr.htm Last visited 29th June, 2008.
14. Nilstun T Lakartidningen (1994): [New guidelines on research ethics from CIOMS (Council for International Organizations of Medical Sciences). A good example of balancing autonomy, benefits and human rights], 91: at pp157-158.
15. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 1996. http://www.ich.org/cache/compo/276-254-1.html Last visited 13th June, 2008.
16. European Union. Directive 2001/20/EC, 4th April 2001.
17. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine,1997. http://conventions.coe.int/treaty/en/treaties/html/164.htm Last visited 10th June, 2008.
18. UNESCO: Universal Declaration on Bioethics and Human Rights. http://portalunescoorg/shs/en/file_downloadphp/46133e1f4691e4c6e57566763d474a4dBioethicsDeclaration_ENpdf 2005. Last visited 14th June, 2008
19. Weijers C, LeBlanc G. (2006) “Revisiting the ethics of HIV prevention research in developing countries”. XVI International AIDS Conference 2006. Toronto. TUAE0302 August 16.
20. Nilstun T (1994): [New guidelines on research ethics from CIOMS (Council for International Organizations of Medical Sciences). A good example of balancing autonomy, benefits and human rights]. Lakartidningen 1994, 91:157-158.
21. See Supra note 19.
22. As cited by the Indian Brand Equity Federation, available at www.ibef.org. These figures include contract work that is generated domestically as well as by foreign sponsors—not just clinical-trial activity, but also the manufacturing of active pharmaceutical ingredients.
23. Sunder Rajan(2005), ‘Subjects of Speculation: Emergent Life Sciences and Market Logics in the US and India’, American Anthropologist, vol. 107, no. 1 pp. 19–30. See also Bio capital, Chapter 2.
24. Except that direct-to-consumer advertising, an important strategy is not allowed in India. Instead, such marketing is aimed exclusively at physicians. Stefan Ecks, ‘Global Citizenship Inc: Big Pharma and “Depression Awareness” in Urban India’, Asian Biotechnologies workshop paper presented at Honolulu, 2006.
25. Joseph Dumit (2006), ‘Living in the Aggregate: Accumulating Prognoses, Growing Markets, Experimental Subjects’. Paper presented at American Anthropology Association meeting, San José, 2006.
26. These reports have been gathered from various articles by Ganapati Mudur in the British Medical Journal and Amit Sengupta in the Indian Journal of Medical Ethics. Also see Info Change News & Features, November 2005, Web Site www.infochange.org. Last visited 24th August, 2008.
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