Geneva Health Forum Archive

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An Overview of the TRREE for Africa Project

Author(s): Marie Hirtle1
Affiliation(s): 1Biotika Inc., Mont-Royal, Canada
Key issues: Ensuring the protection of persons who participate in research, especially in clinical drug trials, and promoting the highest ethical standards for research involving humans is the responsibility of many actors who participate in international collaborative research. And, while international and national regulations apply to some aspects of clinical trials, many others fall under ethical principles and processes that require interpretation and judgment to ensure subject protection and to promote highest ethical standards in concrete situations. Despite this difficult task, those involved in research involving humans receive little or no training and support to enhance their understanding and comfort level of the legal and ethical framework that applies to research involving humans.
Meeting challenges: TRREE-for Africa (Training and Resources in Research Ethics Evaluation) is a project that aims at developing a distance learning programme on research ethics for all those involved in ensuring research participant protection and in promoting highest ethical standards in international collaborative research. TRREE-for Africa will also provide a platform for a participatory website of resources that apply to research involving humans.
Conclusion (max 400 words): This presentation will describe the origins of this project, its goals, anticipated challenges and the proposed results.

A Short Overview of the KFPE and an Introduction to the Session

Author(s): Jon-Andri Lys1
Affiliation(s): 1Commission for Research Partnership with Developing Countries, KFPE, Bern, Switzerland
Key issues:

The KFPE (The Commission for Research Partnership with Developing Countries) is dedicated to promoting research partnerships with developing and transition countries. In this way, it wishes to contribute to sustainable development. The KFPE is engaged in Swiss scientific policies and is committed to promoting the interests of researchers and their affiliated institutions on both national and international levels. It furthers development-oriented research and elaborates research-strategic concepts. In this context, it ascertains that partnership principles are followed, that the quality of research is assured, and that the interests of all partners are respected. The KFPE is a commission of the four Swiss scientific Academies. This session, Research Networks in Partnership, gives an introduction and an overview of a new initiative of partnership and ethics in research called TRREE. Research partnerships and ethics are also two central topics of interest for the KFPE. TRREE (Training and Resources in Research Ethics Evaluation) for Africa will provide training in research ethics evaluation designed specifically to address the ethics of clinical trials conducted in Africa that must comply with international ethical standards. The session will highlight various aspects of such research networks in partnership, such as the challenges or pre-conditions of such networks or assessing the needs for the evaluation of ethics in research.

The Raft Network: Five Years of Distance Continuing Medical Education and Tele-Consultations via the Internet in French-Speaking Africa

Author(s): Cheick Oumar Bagayoko1, O. Ly2, A. Geissbuhler1
Affiliation(s): 1Informatique Médicale, Hôpitaux Universitaires de Genève, Geneva, Switzerland, 2REIMICOM, Hôpital Mère Enfant, Bamako, Mali
Key issues:

Continuing education of healthcare professionals is a key element for the quality and efficiency of a health system. In developing countries, this activity is usually limited to capitals, and delocalized professionals do not have access to such opportunities, or to didactic material adapted to their needs. This limits the interest of such professionals to remain active in the periphery, where they are most needed to implement effective strategies for prevention and first-line healthcare. Telemedicine tools enable the communication and sharing of medical information in electronic form, and thus facilitate access to remote expertise. A physician located far from a reference centre can consult colleagues remotely in order to resolve a difficult case, follow a continuous education course on the Internet, or access medical information from digital libraries or knowledge bases. These same tools can also be used to facilitate exchanges between centres of medical expertise: health institutions of a same country as well as across borders. Since 2000, the Geneva University Hospitals have been involved in coordinating the development of a network for eHealth in Africa (the RAFT, Réseau en Afrique Francophone pour la Télémédecine), first in Mali, and now extending to 10 French-speaking African countries. The core activity of the RAFT is the webcasting of interactive courses. These sessions put the emphasis on knowledge sharing across care professions, usually in the form of presentations and dialogues between experts in different countries. The technology used for the webcasting works with a slow (25 kbits/second) internet connection. Other activities of the RAFT network include visioconferences, teleconsultations based on the iPath system, collaborative knowledge bases development, support for medical laboratories quality control, and the evaluation of the use of telemedicine in rural areas (via satellite connections) in the context of multisectorial development.

Meeting challenges: Equitable access to medical knowledge and information for the developing countries and valorization of the local content.
Conclusion (max 400 words):

Finally, a strong emphasis is put on the development of capacities for the creation, maintenance, and publication of quality medical didactic contents. Specific courses are organized for the national coordinators of the network to develop these competencies, with the help of the Health On the Net Foundation. The richness of the plurality of knowledge and know-how must be steered towards emulation and sharing, respectful of each partner’s identity and culture. Collaborative projects with UNESCO and the WHO have been initiated to address these challenges.

GHF2006 – LS01- Improving Access to Quality Medicines: Health Partnerships for the Developing World and the Fight against Counterfeiting

Session Outline

Lunch Session LS01, Wednesday, August 30 2006, 16:00-17:30
Chair(s): Eric Noehrenberg, International Federation of Pharmaceutical Manufacturers and Associations, Geneva, Switzerland
Anna Wang, Medicine for Malaria Venture, Geneva, Switzerland
Dirk Engels, Department of Neglected Diseases, World Health Organization, Geneva, Switzerland
Julian Morris, International Policy Network
Tesfamicael Ghebrehiwet, International Council of Nurses, Geneva, Switzerland

Session Report

Submitted by: Caroline Rheiner (ICVolunteers); Contributors: Martin Elling (ICVolunteers), Marie Mac Gehee (ICVolunteers), Tatjana Schwabe (ICVolunteers)

Image: Jorge Garbino, ICVolunteers.org

The availability of quality and non-counterfeit drugs is an essential part of any health care delivery service. This session presented the audience with information related to the expansion of private-public partnerships (PPPs) for the development of safe drugs and of drugs for neglected diseases. The speakers also pointed out the danger of counterfeit drugs and the efforts undertaken to combat this serious and life threatening menace.

Dr. Eric Noehrenberg, Director, International Trade & Market Policy, Partnerships and Public Health Advocacy, of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), opened the symposium with a presentation on neglected diseases.

Dr. Noehrenberg reminded the audience that today, more than 65 million people are infected with HIV/AIDS and that 95% of them live in developing nations. Although 23 drugs have been developed since 1987, HIV/AIDS, TB and Malaria together kill more than 20,000 people each day. The research-based pharmaceutical industry has recognized the issue and has developed a business model with the following key elements:

Preferential pricing, such as "not-for-profit" pricing, and also major donation programs for drugs in well over 100 countries as well as community investment, in many countries. Commitment to innovative partnerships that include for example voluntary licensing granted for medication for HIV/AIDS or multi-drug resistant TB. IFPMA Members also promote research and development (R&D) into vaccines for neglected diseases through Public-Private Partnerships (PPPs). Today, an unprecedented level of research has been stimulated to develop badly needed new drugs for diseases such as Chagas' disease, African trypanosomiasis, onchocerciasis, leishmaniasis, schistosomiasis, leprosy, lymphatic filiriasis, Dengue fever, Guinea worm and blinding tracoma. According to the London School of Economics (LSE), the PPP model is working and the landscape of R&D into these diseases has been transformed. Today, there are already 63 new drug projects for neglected diseases, excluding HIV/AIDS.

Dr. Noehrenberg concluded that PPPs are successful but require additional resources. Well funded PPPs can bring the expertise of a range of partners together and create an innovative environment well beyond what individual partners would be capable of alone.

Ms. Anna Wang of the Medicine for Malaria Venture (MMV) addressed the positive impact PPPs can have on the fight against malaria. For example, MMV's mission is to discover, develop and deliver safe, effective and affordable anti-malaria drugs. Other PPPs can also play a catalytic and innovative role in the development of affordable drugs. For most local communities, the biggest obstacle is not the lacunae of medication, but political commitment and funding. The pooling of collective knowledge, talent and resources can improve the situation and consequently save millions of lives (http://www.mmv.org/rubrique.php3?id_rubrique=11).

Dr. Dirk Engels, from the Department of Neglected Diseases at the WHO, explained how the best applicable tools for use in the field were those that were simple to detect and administer, and that were cheap and safe. Drugs for most neglected diseases were increasingly available through public-private partnerships, access programmes and donations from pharmaceutical companies and generics but that certain diseases, such as leishmaniasis, African trypanosomiasis, and the bureli ulcer were still lagging behind due to increased drug resistance and the cost or complexity of diagnosing and treating these illnesses. The key to treating neglected diseases lies in a long-term commitment by all stakeholders, especially governments, and through mass interventions like vaccination campaigns, community directed care and door-to-door interventions. This also implies sustained funding and breaking the cycle of insufficient generic production which was caused the lack of market opportunities for this group of diseases. Supplementary information on this subject by Dr. Engels and his colleagues can be found at the following website: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10%2E1371%2Fjournal%2Epmed%2E0030283.

The symposium continued with a presentation by Dr. Julian Morris from the International Policy Network on the dangers posed by counterfeit medicines. Counterfeit medicines are a n important and growing threat to patients' safety. This problem is not restricted to lower income countries, although it is more pronounced there: the percentage of counterfeit and substandard drugs can reach 25% in low and middle income countries (and even 40% in certain Chinese cities). The impact is devastating. For example, the WHO reported that in 1995 more than 2,500 deaths were caused by counterfeit meningitis vaccines. Other risks concern the hazard of increased drug resistance and the increased cost of treatment. A trend is for local communities to return to their traditional medicines as they lose faith in modern drugs.

Dr. Tesfamicael Ghebrehiwet, Consultant, Nursing & Health Policy of the International Council of Nurses (ICN) in Geneva, Switzerland, made a presentation on ICN's efforts to raise awareness of the dangers of counterfeiting in many countries. The ICN takes this issue very seriously. As nurses are the largest group of health care providers who, in addition, are also close to the patient, they are often the first to recognize treatment failure.

It is clear that there is an urgent need to raise public awareness regarding the dangers of counterfeit drugs. This will not only require the education of the general public and the dissemination of information, but will also include the lobbying for fair prices for authorized drugs and the monitoring and reporting of the occurrence of counterfeit drugs. Dr. Ghebrehiwet proposed greater collaboration between a wide range of technical and law-enforcement agencies including the International Federation of Pharmaceutical Manufactures and Associations (IFPMA), Population Services International (PSI) in Washington, the International Alliance of Patients' Organization (IAPO), Interpol and the World Health Professions Alliance (WHPA).

Dr. Eric Noehrenberg, wrapped up the presentations by stating that the IFPMA was working in collaboration with the WHO in order to raise awareness among policy makers, criminalize the production and distribution of counterfeit goods, allocate greater resources to curb the threat caused by such deleterious activities, tighten the screening and control of the supply chain, and increase interdisciplinary and international collaboration in the sustained fight against piracy, which has become a "public health emergency". IFPMA is collaborating with WHO in the IMPACT (International Medical Products Anti-counterfeiting Task Force) initiative and co-sponsored an international meeting in Rome to launch IMPACT. Details can be found at the WHO web site: http://mednet3.who.int/cft/.

Additional information can be found on the following websites: http://www.ifpma.org/pdf/IFPMA_counterfeit_conference_16Feb06.ppt#256,1 and http://www.who.int/bulletin/volumes/84/9/06-010906/en/index.html

Can Research Make a Difference in Global Access to Health?

Author(s): Stephen A. Matlin1
Affiliation(s): 1Executive Director, Global Forum for Health Research, Geneva, Switzerland
Key issues:

Health research has several crucial roles to play in ensuring that people everywhere have access to health. These roles include the creation of knowledge, tools and products; ensuring that new products such as drugs, vaccines, diagnostics and appliances are created, especially to deal with diseases and health problems that are mainly endemic in developing countries; providing evidence to establish equitable financing systems and well-functioning health systems to ensure affordability, access and uptake of interventions, even by the poorest and most marginalised in society. It is widely recognized that far too few resources are devoted to addressing the health needs of developing countries. As a result of this 10/90 gap: (1) during the last few decades, very few new products for infectious diseases were registered for clinical use, with the private sector inadequately addressing the need for new or improved therapies for diseases that are mainly endemic in poor countries; (2) the development of health systems in low- and middle-income countries (LMICs) has not been effectively supported by health research to inform policy and improve programme delivery; and (3) the research capacities of LMICs to address national health priorities have not been sufficiently developed.

Meeting challenges:

The public sector, which overall accounts for nearly half of the total global spending of over US$ 100 billion per year on health research, has a crucial role to play in financing health research to address this 10/90 gap. Governments in both developed and developing countries need to contribute to this effort, in proportion to their capacities and resources.

Conclusion (max 400 words):

In particular, the public sector in high-income countries can contribute in a number of important ways. It can devote an increased share of the available research resources to the health needs of developing countries, including directing more basic research towards creating new drug leads for important diseases found mainly in LMICs. The public sector can also substantially increase support for public-private partnerships in the health field that are now creating an important pipeline of potential new products. The public sector of developed countries also has a crucial role to play, by encouraging and supporting research capacity building and utilization in LMICs. At the same time, the public sector in LMICs themselves must also increase its support for health research. Notably: support the development of a national health research system, to ensure that local research capacity to address priority health needs is built and utilized; especially in the case of innovating developing countries (IDCs) such as Brazil, China, India and South Africa, develop policies and devote resources to ensure that the IDCs use part of their newly evolving capacity to address their own and other developing countries endemic diseases, rather than focusing exclusively on products that target the more lucrative markets in developed countries.

Towards Improving Transparency in Clinical Trials

Author(s): Odette Morin1
Affiliation(s): 1Director, Regulatory and scientific Affairs, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Geneva, Switzerland
Summary (max 100 words): The IFPMA Clinical Trials Portal www.ifpma.org/clinicaltrials is the first internet search engine to link to online information about on-going and completed clinical trials sponsored by research-based pharmaceutical companies worldwide. Created to help fulfill the pharmaceutical industry’s commitment to increase the transparency of clinical trials, the Portal provides doctors and patients with easy access to online information about clinical trials of drugs and vaccines. As part of IFPMA’s ongoing efforts to improve the Portal, it now allows multiple-criteria searches in French, German, Japanese and Spanish, as well as English, via an easy-to-use interface. The Portal incorporates a powerful multilingual synonym function, which allows use of common names for medical conditions, circumvents spelling mistakes and permits searches to be expanded to include related conditions.

Putting Research Evidence into Practice

Author(s): Nirmal Kumar Ganguly1
Affiliation(s): 1Director General, Indian Council of Medical Research, New Delhi, India
Key issues: Impressive strides have been made in biomedicine and it is on account of the results of health research that the people enjoy a longer life expectancy through use of products of research like the vaccines, drugs, diagnostics, better management of diseases and life threatening conditions. However, benefits of health research are not available to those countries, communities and individuals that need it most.
Meeting challenges: In India, the burden of ill-health is higher among the poor. The infant mortality rate is two and half times higher and the under-five mortality rate is three times higher in the lowest quintile of the population as compared to the highest. The total fertility rate in the highest quintile is almost half that of the lowest quintile of the population. Although the burden of disease is high among the poorest quintile, their access to health services is limited. The poorest 20% of the population get only 10% of the public subsidies for curative care. There is an urgent need, therefore, to identify approaches and means to translate knowledge to effective interventions to improve access to health care and services. This means better utilization of existing tools, development of new tools for diagnosis, treatment and prevention of diseases as well as working out strategies that would result in their reaching the population in greatest need.
Conclusion (max 400 words): The research activities of the Indian Council of Medical Research (ICMR), the apex body for biomedical research in the country are aimed at reduction of poverty through income-generating schemes, catalysing community participation in disease control programmes, developing innovative strategies that generate income, decreasing the man-days lost due to illness and loss of wages by developing more effective treatment and of shorter duration. Studies aimed at promoting gender equality and empowering women for contraceptive choices have led to the development and introduction of newer contraceptives including emergency contraception and safe abortion methods in the country. To improve child survival, studies on home-based newborn care interventions, estimating the disease burden for vaccine-preventable diseases and evaluating alternative modes of delivery of existing vaccines have led to some effective management strategies. Studies for improving maternal health have led to the development of feasible and cost-effective methods and management strategies to prevent and treat maternal morbidities. Research in nutrition has led to the formulation and implementation of national nutrition programmes, use of iodized salt and availability of fortified foods in the country. Development of diagnostic kits and effective treatment regimens for infections such as HIV/AIDS, malaria, TB and others diseases like Leishmaniasis have been given additional emphasis. Studies to understand the disease burden, epidemiology, risk factors and also genetic disorders like heamoglobinopathies have provided inputs for development and implementation of national health programmes and integrated disease surveillance in the country. Research in diabetes has facilitated preventive measures and improved management strategies. Mapping of diseases like cancer has helped in formulating strategies for prevention and management. For ensuring environmental sustainability, studies on impact of air pollution, occupational exposures, monitoring pesticides in environment and food and developing bio-markers for detection of environmental toxins have been carried out. Pre-clinical and clinical testing of newer molecules developed by Indian pharmaceutical companies has led to production of newer drugs for disease management. The clinical trial registry at ICMR will further help in evidence-based interventions and implementation of best practices in the country.

GHF2006 – PS14 – Research & Access to Health: Ethical Concerns

Session Outline

Parallel session PS14, Thursday, August 31 2006, 16:00-17:30
Chair(s): Nirmal Kumar Ganguly, India, Alexandre Mauron, Switzerland
Eduardo H. Gotuzzo, Instituto de Medicina Tropical, Universidad Peruana Cayetano Heredia, Lima, Peru 
Ethical Aspects of Clinical Research in Africa: A Positive Experience from Mali
Ogobara K. Doumbo, Professor, Malaria Research and Training Centre, University of Bamako, Mali  
The Importance of the National Laws in the Implementation of International Regulations in Developing Countries
Dominique Sprumont, Institute of Health Law, University of Neuchâtel, Neuchâtel, Switzerland

Session Document

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Session Report

Submitted by: Shibani Bandyopadhyay (ICVolunteers); Contributors: Tatjana Schwabe (ICVolunteers)

The symposium on "Research and Access to Health: Ethical Concerns" has highlighted the fact that strong laws are a powerful tool to protect participants in experimental clinical trials. Presentations on Clinical Research in Latin America and the importance of national laws in the implementation of international regulation in developing countries introduced some of the complexities of ethics involved in clinical trials.

The co-chair, Dr. Alexandre Mauron from the Medical Faculty of the University of Geneva, Switzerland, introduced the topic of ethical concerns in health research, stressing that clinical trials had become a global activity, requiring discussion about ethics in research to be a priority.

Dr. E. H. Gotuzzo from Instituto de Medicina Tropical Alexander von Humboldt in Lima, Peru presented his paper on "Clinical research in Latin America: constraints and opportunities". He pointed out that currently between 11 - 25 % of all clinical trials (CT) are being conducted in Latin America, involving numerous sites and professionals in the trials themselves and the related ethical review work. Dr. Gotuzzo first listed the advantages of conducting clinical trials in Latin America:

  • A vast heterogeneous study population with patients suitable for many CTs available in the mega cities of Argentina, Mexico, Brazil and Colombia;
  • Minimal drop out rates;
  • Trained personnel with good clinical practices;
  • Potential markets for pharmaceutical industries;
  • Possibility to conduct year-round trials on seasonally induced diseases (e.g. diarrhoea or respiratory diseases) in combination with countries in the Northern hemisphere;
  • Dr. Gotuzzo pointed out that most clinical trials in Latin America are being carried out by private industry, while only about 100 trials are being conducted by the US-American National Institutes of Health (NIH), universities or other public institutions. About 80 % of the clinical trials in Latin America analyse new vaccines against rotavirus, papilloma virus or HIV.

However, clinical trials in Latin America face a number of challenges including:

  • Lengthy approvals due to government regulations;
  • Corruption (as large sums of money are often involved in CTs);
  • Forged CT results;
  • Low priority of clinical trial output product;
  • Severe unrest threatening the continuation of  CTs as seen in Argentina (2001), Venezuela or Peru (1990);
  • Ethical issues such as acquisition of study subjects and informed consent.

Regarding the last point, Dr. Gotuzzo explained that in the paternal patient-doctor relationship in Latin America, informed consent of patients was an unfamiliar concept. During the question and answer session, the issue of informed consent by vulnerable, handicapped or mentally ill patient was briefly raised. Answering a question from the audience, the speaker argued that the hope to improve the health situation was the main reason for countries with limited resource and increasing drug resistance to participate in CTs.

In his conclusion, Dr. Gotuzzo urged for more transparency and clear requirements, amongst others through the strengthening of health systems, to determine whether a clinical trial is carried out according to appropriate ethical standards. CT participants-and possibly also the institutions and countries in which these CTs are conducted-should benefit more directly from the CTs as today, frequently, the CTs only benefit western development.

In the absence of Dr. Doumbo from Mali, Dr. Hassan Mshinda, Director of the Ifakara Health Research and Development Centre in Tanzania kindly agreed to talk about his experience regarding ethical is regarding clinical trials in Africa. In partnership with the Special Programme for Research and Training in Tropical Diseases (TDR) and the WHO, skills in applying ethical standards in CTs have been developed by the training of staff in Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and ethics.

Dr. Mshinda pointed out that Tanzania is taking several steps to ensure that ethics standards are applied in clinical trials. Ethical clearance is mandatory and a licence is required for each product to be tested in a CT. The composition of the ethical board has changed to include independent legal and gender representatives in addition to professional scientists and clinicians. Tanzania accepts the responsibility for all research work undertaken in the country, for example by refusing to engage foreign nationals as principal investigators of any research work or by including an independent country representative in the data monitoring safety board of a multi-centric study by a foreign pharmaceutical company. This is crucial, as a local investigator will, unlike most foreign stakeholders, still be there to take responsibility should a problem arise after completion of a research protocol. He also pointed out that in this particular biosocial context, verbal consent was largely prevalent over written consent. Implementation of community consent also raises largely unexplored difficulties. Such socio-cultural issues can pose problems for ethical guidelines requiring individual and written informed consent.

Dr. Dominique Sprumont, Director of the Institute of Health Law at the University of Neuchatel, Switzerland introduced the "Importance of the National Laws in the Implementation of International Regulations in Developing Countries". At the beginning of his talk, he pointed to the complex documents regulating research on an international level such as the Geneva Convention, the Nuremburg Code, the Declaration of Helsinki, the International Convention on Civil and Political Rights, WHO International Ethical Guidelines and European Union (EU) Directives. Both the EU directives and the National Law aim predominantly at protecting the subjects of clinical trials. Another body to issue guidelines on Good Clinical Practice (GCP) was the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In its principle 26, it demands that all CTs be conducted under the supervision of an Institutional Review Board (IRB) and Independent Ethics Committee (IEC), both of which have to be approved by the "competent body". What constitutes a competent body is left open to interpretation in the document and definitions differ from country to country. Another area, where definitions differ is that of informed consent. Dr. Sprumont presented examples from Benin, Mali and Senegal, where the definitions of child, incompetent adult and legal representative vary. Even across Europe, concepts concerning the competent authority for consent and legal competency are not uniform. In the light of the heterogeneous world of many diverse but equal sovereign countries, Dr. Sprumont concluded that national regulation was the only way to provide specific rules on key issues in biomedical research. He stated that the respect for national regulations was essential for partnership in international research and capacity building.

Dr. Mauron concluded the session by emphasising the importance of including only fully informed participants in clinical trials. To avoid the disseminating of misleading information, clinicians and research workers need guidance from other disciplines, including legal experts, to prepare the information that is to be shared with patients.

Clinical trials are the most important tool in medical research to find the best therapy or method for intervention. While CTs have so far been mostly ruled by biostatistics, more emphasis is now being placed on human rights and ethical concerns. Since research is becoming more and more industrialised, national law has to ensure that international regulations and ethics guidelines are implemented in each country and hence the need to ensure that research protocols are compatible with different local laws. This in turn leads to the question of which research institute has the final say in multi-centre research.



Clinical Research in Latin America: Constraints and Opportunities

Author(s): Eduardo H. Gotuzzo1, E. Gonzalez Lagos2
Affiliation(s): 1Instituto de Medicina Tropical Alexander von Humboldt, Lima, Peru 2Instituto de Medicina Tropical, Universidad Peruana Cayetano Heredia, Lima, Peru
Key issues: Over the past decade, Latin America has evolved into a very dynamic area for conducting Clinical Research, particularly with regard to the development of new antimicrobials and vaccines. Between 1995 and 2000, the number of clinical trials executed in the region rose over a factor of ten.
Meeting challenges: Several reasons converge to explain why Latin America is currently perceived as an attractive alternative for clinical research. Firstly, health care systems in many Latin American countries, as well as the availability of adequately trained clinical investigators, have progressed positively since the 1990s, being closer than ever to the available standards in Western societies. Secondly, local investigators have become familiar with international regulations, including Good Clinical Practice and Good Laboratory Practice. Thirdly, throughout adequately constituted Institutional Review Boards, supervision of adherence to and compliance with international regulations is increasingly available. Fourthly, many Latin American governments have so far deliberated and legislated in the field, with clear processes that define regulatory instances and terms for approval processes, as well as those that deal with import and handling of drugs. Fifthly, the extended network of transport and world-wide communication facilitates standards of operation and overseas coordination at reasonable costs, with an increasing number of monitoring companies opening offices in Latin America. Additional, long-standing reasons make Latin America an advantageous area to conduct clinical research. These include the large and heterogeneous ethnic and epidemiological profile of the populations, the important proportion of children, the low exposition to other medication that could interfere with experimental treatments, the high retention rates traditionally reported in Latin American sites and the financial conditions that ultimately allow conducting trials at lower costs than in Western countries. Undeniably, some issues stand as challenging concerns. Despite the respectful adherence to the informed consent process, the individual’s autonomy might be at a certain point constrained if, due to financial limitations and lack of a universal security system, participation in a clinical trial represents the only way to ensure the alternative of a treatment that could not otherwise be afforded, a frequently encountered situation in most Latin American countries. Many other potential constraints are related to the ethical aspects of transcultural research. Whereas ethical principles are oriented toward the respect of core rights that should be universally observed and in that sense should be considered absolute, certain variations in their relative priority or the best way to respect them might also be susceptible to local sensitivities and cultural values. It should be taken into account that in developing countries the cultural differences between doctors and patients, researchers and subjects, can be greater than those encountered on average in Western countries, which can also affect the informed consent process. Interestingly, in Latin America the doctorpatient relationship tends to be much more paternalistic than that seen in the majority of Western societies. This vivid archetype makes it difficult for the subject to distinguish the doctor from the researcher and the messages that pertain to each one, with the subject remaining prone to consent easily when asked by a trusted authority.
Conclusion (max 400 words): In conclusion, Latin America displays an increasing capacity to participate adequately in a growing number of clinical trials, but thorough consideration should be devoted to ethical transcultural issues.

GHF2006 – PS10 – Hospital and Academic Networks

Session Outline

Parallel session PS10, Thursday, August 31 2006, 11:00-12:30
Chair(s): Peter Suter, Switzerland, Peter Saladin, Switzerland
Social Accountability of Medical Schools in a Globalized World
Kendall Ho, Continuing Professional Development & Knowledge Translation, University of British Columbia, Vancouver, Canada 
Troped Network: Bringing Together European Institutions for Higher Education in International Health 
Jean-Pierre Gervasoni, Unit for Cardiovascular Disease and Epidemiological Transition, IUMSP, and Swiss Tropical Institute, Basel, Switzerland
Capacity Building and Partnerships: ESTHER's Experience
Michel Lo Casto, Advisor for hospital relations, GIP ESTHER, France

Session Documents

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