Barriers may vary widely depending on the context in which the clinical trials are conducted. Vol 1. Essential national health research: a key to equity in development. McMichael C, Waters E, Volmink J. Evidence-based public health: what does it offer developing countries? They are more demand-led and responsive to a countrys needs because they are driven by a local or national agenda [77]. Birkhuser Basel. We reviewed the literature on barriers facing clinical researchers in resource-poor settings, and found only a small number. Combining single patient (N-of-1) trials to estimate population treatment effects and to evaluate individual patient responses to treatment. Recruitment of trial participants is easier than in the developed world; large outcome trials that require enrolment of thousands of patients could make huge savings for the sponsor if the trial is conducted outside of developed countries [74]. Google Scholar, World Health Organization (2000) Operational guidelines for ethics committees that review biomedical research. With the exception of concerns around time [40, 48, 51, 53], reported barriers for conducting clinical trials were similar between these two groups, with financial and human barriers being the most common in both groups. Front Genet. However, access . The study considered to be of low quality showed a high risk of selection bias secondary to purposive sampling procedure for participant selection as well as a low response rate (27%). These guidelines exist both to protect participants and to ensure the integrity of the study results. We would like to express our thanks and appreciation to Marcos Riba for his technical support in conducting the review. Another systematic review identified barriers as system-organization barriers (time involvement and resource issues), trial design-related barriers, and physician-related barriers [56]. Zegers-Hochschild F. Barriers to conducting clinical research in reproductive medicine: Latin America. Fayter D, Mcdaid C, Ritchie G, Stirk L, Eastwood A. Semin Neurol. The time from initiation of all regulatory procedures to the actual start of the trial was very long. This report concluded that despite the overall increase in clinical trials over the last two decades, the progress of clinical trials in developing countries was particularly slow and challenging. GUID:49D1E6E9-902A-48C8-810B-C2DB96F20261, GUID:DF0233D4-99F4-44FA-BD99-4A3544498A1B, GUID:B54AADAC-A281-4047-96EA-A9F8C7049DE3, Report on barriers/challenges for conducting research, specifically clinical trials within developing countries. Although many of the issues confronting clinical trialists working in resource-limited settings are the similar, the human and other resource capacity of developing countries lags far behind that available in wealthier nations [57]. Reich MS, Shaw J, Barrett I, Goldberg VM, Schnaser E. Public Health Ethics. When designing clinical trial or considering decision to take part in particular clinical trial as investigators, even before submission to responsible Central Ethic Committee, we always make certain private assessment about ethical justification of this clinical trial. Tallo V (2003) Evaluating comprehension of informed consent: how should it be done? Finally, as the key findings were similar across studies, we chose to present and discuss the unifying themes and include both for the quantitative and qualitative studies in each theme. These countries health care systems need evidence to guide decisions about the most efficient and cost-effective interventions for them. Even within the paucity of literature on conducting clinical trials in low resource countries, the literature mostly relates to ethical issues [19, 2628]. . Oral Presentation at the 3rd African Conference on Ethical Aspects of Clinical Research in Developing Countries. This paper examines each of these issues separately. Following critical review we identified five unifying themes for barriers. Stober M (2003) Multinational clinical trials: breaking language and cultural barriers. Earlier this year, the National Bioethics Advisory Commission (NBAC) issued a report on ethical and policy issues in international research, and the AMA passed a new recommendation on ethical considerations in international research at its 2001 Annual Meeting in June. Google Scholar, Anonymous. Conducting more clinical trials in these environments will build confidence in the ability to perform them well, and many under-resourced people will benefit in the long term. SOURCES AND METHODS: Review of literature on ethical principles of research in developing nations. 2007 Sep 19;8:10. doi: 10.1186/1472-6939-8-10. However, complex and overly strict ethical and regulatory systems could worsen the negative feedback loop between limited research capacity and small numbers of trials conducted. Clinical trials in developing countries - ethical considerations Authors Marija Bosnjak Pasic 1 , Branka Vidrih , Helena Sarac , Hanna Pasic , Luka Vujevi , Anamarija Soldo Koruga , Fabijan Raji Affiliation 1 School of Medicine, University of Osijek, 31000 Osijek, Croatia. Shapiro and Meslin grant that the "an experimental intervention should normally be compared with an established, effective treatment . CrossRef PubMed CAS . The https:// ensures that you are connecting to the Siegfried N, Volmink J, Dhansay A. Assessment of study quality for qualitative studies. whether or not that treatment is available in the host country." One article discussed the regulatory challenges associated with conducting multi-country clinical trials in resource-limited settings (Africa, Asia, South America, and the Caribbean) [60]. BMC Med Ethics. Soc. This is reflective of the 10/90 gap, in which less than 10% of health research funds in the world are directed toward problems that affect 90% of the worlds population, and an even smaller percentage go to fund researchers and health problems indigenous to developing countries [6, 7, 61]. In this essay the ethical issues related to the 'standard of care' are discussed together with the implications for the treatment of the control group in trans-national clinical trials. Mapping of available health research and development data: what's there, what's missing, and what role is there for a global observatory? Ethical Issues in Clinical Research Studies - QPS Missouri 2007 Aug;12(4):318-23. doi: 10.1016/j.siny.2007.01.023. A new colonialism? Geneva: WHO Technical Report Series; 1995. Does South Africa need a national clinical trials support unit? Clinical trials of medications and procedures for neuropsychiatric conditions raise particular ethical concerns, especially protecting vulnerable subjects in developing countries during the consent process. Li R, Barnes M, Aldinger C, Bierer B. In the other study, sample size was not justified and there is no description of the sampling strategy [52]. Ethical issues in clinical trials - ScienceDirect This research focuses on the ethical issues associated with the outsourcing of medical research, Contract Medical Research (CMR) to Contract Research Organizations (CROs) in emerging markets. Preventing mother-to-child transmission of human immunodeficiency virus type 1 in resource-poor countries. Building scientific capacity is much more than simple science and technology transfer from the developed world to the developing world. First two reviewers (CM and JN) independently identified key concepts, then compared and analyzed them to identify predominant/recurrent themes across studies. Regarding health conditions, six (60%) of included studies assessed barriers of conducting clinical trials on non-specific health conditions. MeSH Many times physicians/clinical researchers from developing countries are faced with the criticisms that they are not of the same quality as physicians from developed countries and that they can be easily bribed by sponsors, which are based on the prejudice that any clinical trial can be executed in developing countries, no matter of quality or risks for patients. Unable to load your collection due to an error, Unable to load your delegates due to an error. Federal government websites often end in .gov or .mil. The number of registered international clinical trials that include India have increased by 30% each year for the past three consecutive years for many of the reasons outlined above [79, 80]. Angell M. The ethics of clinical research in the third world. Appl Clin Trials 12: Nov 2. www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=77704, Brady JS (2003) Multimedia delivery can enhance the consent process. Any disagreements that arose between the reviewers were resolved through discussion, or with a third reviewer (GM). Lack of funds was the most commonly cited reason reported in the included studies. Research capacity strengthening in Africa: trends, gaps and opportunities. After removing duplicates, the topic and abstracts of 1915 published articles were screened to check if they were eligible for this review. clinicaltrials.gov. [. Most of the included studies were qualitative studies with small sample size and narrow diversity of participants. However, if the human participants protection system of the host country or a particular host . Currently, less than 20% of clinical trials are being conducted in developing countries [54], and only 1% of the recently discovered drugs are aimed at management of tropical diseases [55]. We propose that to address this problem, instituting a system for wider implementation of local investigator-initiated trials is warranted. Ethics and regulatory review procedures are critical for protection of the safety and interests of the participants. Gaillard J. A recent review indicated that about one-third of 509 clinical trials sponsored by US-based companies from 1995 to 2005 were conducted outside the USA, many in poor and low-income countries [19], without targeting diseases prevalent in these countries. Chalachew Alemayehu, Phone: +251-942207528, Email: moc.oohay@elahctseb. Ten studies, which are reported in 15 papers, were included in this review. To realize this, instituting a system for wider implementation of local investigator-initiated trials is warranted. J Am Med Ass 283: 27012711, World Medical Association (2000) Declaration of Helsinki. 2020 Jul 30;15(7):e0236563. 1900 articles were excluded as they were out of the scope of this review (see Fig. Pai H. Barriers to conducting clinical research in reproductive medicine: India. Exploiting the enormous research potential in developing countries has a double contribution as it can address some of the challenges that face the conduct of clinical trials in the developed world. Moreover, a comparison between respondents and non-respondents was not provided as demographic data were obtained only for the respondents [40]-see Additional file 2: Table S1. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands. Can Med Ass J 171: 248249, Bhutta ZA (2002) Ethics in international health research: a perspective from the developing world. Google Scholar, Nuffield Council on Bioethics (2002) The ethics of research related to health care in developing countries. Conducting clinical trials in India. At the same time that the priorities of developed countries drives the research agenda of pharmaceutical companies, there is a disturbing underrepresentation of research addressing priority issues for developing countries [15, 16]. In this essay, we discuss ethical issues in the design and conduct of clinical trials in developing countries. Bookshelf Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials. Federal government websites often end in .gov or .mil. Physician participation in clinical research and trials: issues and approaches. Of the medium quality studies, one had a low response rate (92 out of 40423%) [51]. Barriers for conducting clinical trials in developing countries- a Most of the included studies [41, 4650] relied on qualitative methods. This process is experimental and the keywords may be updated as the learning algorithm improves. Translation and validation of the greek version of a questionnaire measuring patient views on participation in clinical trials. Mass Medical Soc. One article reported lack of policymakers understanding of the importance of research as barrier [50]. Kampala, Uganda, March 1921, 2003. The https:// ensures that you are connecting to the The Global Forum for Health Research report emphasized that strengthening research capacity in developing countries is one of the most effective and sustainable ways of advancing health and development in these countries and of helping correct the 10/90 gap in health research [61]. 2014. Clinical trials in developing countries: ethical issues Leadership commitment to practicing clinicians can also improve the degree of clinical-trial participation through supportive managerial functions, including time and space allocations and individual recognition [72, 73]. Abstract Several ethicists have raised criticisms of various placebo-controlled clinical trials conducted in developing countries between 1995 and 1998. The process of finding key concepts in each study was not always straightforward in the qualitative studies. Lack of research materials for conducting clinical trials [40, 46, 47] and lack of conducive scientific atmosphere (including policy) [43, 45, 50] were also reported. Ranasinghe I, Rong Y, Du X, et al. That, they say, is the "presumed standard." sharing sensitive information, make sure youre on a federal This was particularly difficult in studies that made relatively simple analyses of their findings by describing what their participants reported, without reporting further analysis that identified key findings. Conclusion and recommendation There were substantial barriers at system, organization and individual level. Though these studies had a global focus, they assessed and clearly presented their results regarding barriers and facilitators of clinical trials in developing countries. Ethical Issues in Clinical Trials in Developing Countries This item appears in the following Collection (s) EthxWeb: Literature in Bioethics Show simple item record Showing items related by title, author, creator and subject. Moreover, an inadequate research environment and various operational barriers, including complex and lengthy financial and logistic systems, appeared in many studies. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands. For example, one systematic review regarding barriers for participation of doctors in clinical trials in developed countries identified lack of time as a major barrier [24]. The site is secure. Oncol. THE ETHICAL ISSUES IN CLINICAL RESEARCH PRIMARILY INVOLVES PROTECTION OF RIGHTS, SAFETY, AND WELL BEING OF THE RESEARCH PARTICIPANTS. Medical schools and teaching hospitals in LMIC have poorly prepared their graduates to conduct scientific trials and clinical research. New Delhi, Weijer C (1999) Protecting communities in research: philosophical and pragmatic challenges. Scarce resources in developing countries are nearly all spent on program implementation, and allocating funds for research is almost out of the equation in most development plans. Global status report on noncommunicable diseases 2010. Ethical challenges in genetic research among Philippine Indigenous Peoples: Insights from fieldwork in Zamboanga and the Sulu Archipelago. Because of the limited number of articles in the review, our analysis did not examine the similarities and differences between barriers among the different developing countries. Ethical issues in clinical trial collaborations with developing countries - with special reference to preventive HIV vaccine trials with secondary endpoints Reidar K. Lie, M.D., Ph.D. Department of Philosophy University of Bergen Sydnesplassen 7 N-5007 Bergen, Norway Fax. Edinburg, Vastag B (2000) Helsinki discord? InResearch Involving Human Subjects in Developing CountriesGreg Koski and Stuart Nightingale comment on the NBAC report and on the Declaration of Helsinki, and draw some conclusions of their own. For the majority of questions, all except one study [41] scored good for most criteria. Franzen SR, Chandler C, Atashili J, Angus B, Lang T. Barriers and enablers of locally led clinical trials in Ethiopia and Cameroon: a prospective, qualitative study. Epstein M. Clinical trials in the developing world. We assessed the quality of all included studies and incorporated studies in the review. The authors reported that the regulatory processes in resource limited countries hinder the efficient implementation of multi-site clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

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