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The World Summit on Sustainable Development may have fizzled, but a promising new long-term clinical trials partnership between the EU, industry, and developing countries is in the works.
Most developing countriesand all Third World activistsconsider last summers World Summit on Sustainable Development in Johannesburg, South Africa, to have gone off with more of a whimper than a bang. As far as health care is concerned, the summit provoked few cheers from the champions of greater access to medicines for poor countries. But in the specific area of clinical trials, the European Union used the Summit as a shop window for a project it has been developing over recent months, and which may yet prove to offer some enduring assistance to the populace of countries still ravaged by disease.
The initiative is called the European and Developing Countries Clinical Trials Partnership (EDCTP), which brings together the 15 EU member states and Norway, the developing countries, and the pharmaceutical industry in a joint effort to combat poverty-linked diseases. Nongovernmental organizations are also to be involved where these are effective ways to engage with communities directly affected by these diseases, the EU said when announcing the plan. The EDCTP could provide support for prioritized clinical trials of new drugs and vaccine candidates against HIV/AIDS, malaria, and tuberculosis (TB), which are urgently awaiting clinical testing.
A first partnership
The concept of a long-term partnership between Europe and developing countries is a new oneand this is also the first time the EU has taken the initiative of bringing together the clinical research activities and programs of several member states in pursuit of a common objective. The problem it aims to address is well known. The vicious circle of disease and poverty causes a fundamental public health and economic crisis in developing countries, particularly in sub-Saharan Africa. HIV/AIDS, malaria, and TB alone account for more than five million deaths every year, 95% of these in the developing world.
For years, critics of the drug industry have highlighted what they claim as consistent failures by profit-oriented companies to devote resources to development of medicines for markets that are likely to offer little commercial return. Leaving aside the complex debates that have raged across international forums in the World Trade Organization or the United Nations Commission for Trade and Development over the respective roles and responsibilities of government and private enterprise in facing these problems, one thing has become crystal cleareven when potentially useful medicines might be made available, serious obstacles make it difficult for clinical trials to validate the medicines efficacy in the conditions that they would have to be used in. And this is where the merit of the new partnership lies.
To increase the chances of success, the initiative is based on sharing problems and potential solutions from the earliest stage. The EDCTP is intended to be a true partnership, in that it will evolve under the guidance of developing countries as the drivers of the real needs. So EDCTP has ensured that African clinicians and health system representatives are to take part from the very early stages, enabling them to assume a leading role in its further development. A committee with five European and five African representatives in consultation with the stakeholders drafted the strategic plan. At the same time, the European pharmaceutical industry is setting up an Industry Forum as the EDCTPs industrial focal point to encompass the essential expertise that only industry can provide in the clinical development of new drugs and vaccines.
The program of action
The EDCTP is a response for more and better research and development activities to fight three major diseases. The intention is to rapidly launch a first set of urgent measures. In practical terms, the EDCTP program envisages central European and African management facilities, measures to improve networking of European clinical research programs, support for clinical research capacities in developing countries, and a training scheme for local researchers and clinicians that will strengthen the locally available human resources to guarantee the long-term sustainability of the EDCTP program.Networking and pooling of national trials activities in the EU could include the infrastructures needed in the EU to support these trials (notably Phase 1 trials). Supporting trials activities in developing countries would also cover networking, upgrading trials infrastructures, and transferring know-how and technologies in clinical research. To sponsor these clinical trials, officials plan to put together financial packages that attract external sources of co-financing, particularly in partnership with the pharmaceutical industry.
Experts from Europe and also a growing number of African scientists have been working together on the project for the past few months, under the leadership of the Hospital Clinic of Barcelona. EDCTP differs from many other international initiatives in this field because of its long-term relationship with the beneficiary countries, and because of its conception as a NorthSouth partnership. Other poverty-related diseases and other geographic regions may be included later.
Clinical interventions to be tested through the EDCTP could include simplified combinations of therapy using existing drugs, reformulation of existing drugs, and development of new drugs. Development of new drugs and therapeutic strategies against HIV/AIDSrelated opportunistic infections are also envisaged. So too are immune-based interventions against all three diseases, including development of prophylactic or therapeutic vaccines, combinations of vaccines, and combinations of antiretroviral and immunomodulatory-based strategies. Applicants will be able to apply for EDCTP funds for the conduct of Phase 1, 2, 3, and 4 studies.
Networking is important to win agreement from national programs for support of the clinical trials framework, to identify duplications or gaps within national and/or international activities, and to add value to national activities by bringing together complementary activities in EU countries for expedited clinical trials with clear endpoints for selection of superior clinical interventions for further development.
EDCTP clinical trials sites will be defined. They will have to be able to conduct clinical trials in accordance with ICH GCP regulations, at a level where trials will be accepted by the regulatory authorities for registration and licensing. In developed countries, sites will mean a network of clinical and other research structures to cover the skills required for the design, conduct, and analysis of clinical trials related to HIV and/or TB and/or malaria, under GCP and GLP (good laboratory practice) conditions. Staffing would have to cover principal investigators, physicians, nurses, laboratory staff, data managers, and regulatory experts. A site could be located at one single place, but because of the different skills and facilities needed for some clinical trials, a site could also be developed from the networking of complementary structures to allow efficient use of resources.Developed countries will assess the types of clinical interventions that are required, with timelines for their introduction. The countries will set up a framework to identify the development pipeline, the probable numbers per year, the state of development (Phase 14), and the capabilities and capacities of clinical sites that will be required. They also will assess the infrastructure required to conduct GCP clinical trials (hospital wards, field sites, clinical laboratories and equipment, data management and data filing, repositories for storage of material, and IT support).
Sources of funding
The European Union is going to put E200 million into the EDCTP this year. The program requires E600 million to workand plans call for an additional E200 million worth of activities, which will come from the participation of national clinical research programs in the involved countries. Other donors and the drug industry are expected to deliver E200 million more.
The EU calculates that its member states and Norway will invest a total of more than e1 billion over 20022007 in biomedical research at the national level to develop new clinical means to cure or prevent HIV/AIDS, malaria, and TB. However, while important new research results are obtained, they are not immediately put to use for the development of new health-improved tools that can be applied in developing countries, the EU said in a statement accompanying the launch of the project. It went on to say,
More concretely, new medicines or vaccines emerging from clinical research may prove highly promising in preliminary small-scale clinical trials but may not be developed further into market products in the absence of sufficient funds and/or facilities for the necessary large-scale trials. Such large-scale trials have to be conducted in the diseases-endemic countries under local clinical and social conditions, in order to obtain relevant results that benefit needy populations.
The underlying organizational idea is that the scale of research needed to develop new interventions may be better addressed at a European level than nationally. The EDCTP would thus add value and coherence to national R&D programs and activities such as clinical trials. And success could attract more resources into developing these interventions, potentially accelerating candidate products through the developmental pipeline, and boosting the capacity and capability in developing countries to test their efficacy.
The first major outputs from the strategic plan will include a definition of diseases and a related geographical focus, a needs assessment by the developing countries, and an understanding of potential partnerships of sponsors, scientists, and clinicians for clinical trials, particularly in sub-Saharan Africa. One of the central tenets for action is that EDCTP should not support development of new interventions without a strategic clinical planwhich should include a clear understanding of the basis for cooperation with existing or future industry objectives, a commitment to advance clinical interventions of benefit to sub-Saharan Africa (but also including trials in other clinically relevant geographical areas if required), and a degree of risk-taking to support new interventions that may not otherwise attract private or public funding.
Showing a commitment
The EU is playing the project up for all it is worthpartly out of legitimate pride at a humanitarian action, partly because it could serve to validate some of the EUs repeated declarations about its commitment to broad and worthy goals such as science and North and South cooperation, and partly, perhaps, so that it can be seen to be offering something positive in the course of a major international debate about drug provision in which Europe, and the rest of the developed world, is not looking too generous. The negative publicity about the attempts of European and U.S. drug firms to prevent erosion of intellectual propertywhich peaked last year when a clutch of drug firms eventually backed down from a battle with the South African government about compulsory licensinghad repercussions on the broader attempts by the EU to win over hearts and minds to the need for protecting patents. That battle is still being played out in the continuing discussions of how to implement the so-called Doha Agreementthe deal reached at the 2000 World Trade Organization conference on the way rich countries should share technology with poorer countries. And the background to that conflict is the much wider issue of how to promote free trade at the world level.
The EU knows that it and its developed world partners face an uphill struggle to remove international trade barriers, because its arguments that free trade will promote worldwide growth are still interpreted by many opponents as naked attempts to exploit third-world markets. The spectacle of AIDS orphans, or of entire countries half-crippled by disease among the most active sectors of society, sits uncomfortably alongside speeches by well-fed European diplomats and officials preaching the merits of free trade and enhanced prosperity for all. So anything that can be done to mitigate the contrast could be a valuable contribution to support the positions put forward by developed countries on the bigger arguments.
This is doubtless why, while in Johannesburg, European Research Commissioner Philippe Busquin described the EDCTP program as an initiative that shows our commitment to help developing countries and to make treatment cheaper as well as adapt it to the needs of the poorest countries. He called EDCTP a perfect example of the functioning of the European Research Area.