Clinical trials in africa

Africa does have clinical trial infrastructure and capabilities. But the resources remain unevenly distributed. The vast majority are in Egypt and South Africa. Traditionally, clinical trials are conducted at centres of excellence, which are sites that have the appropriate infrastructure and human skills necessary to conduct good quality trials.

These can be located at a single university or research organisation, or work can be split between a few locations. But setting up these centres requires significant time and financial investment. Most that I am aware of on the continent have developed over the years with heavy support from external partners or sponsors.

In many cases, African governments have not been involved in these efforts. They require continuous funding, the establishment of proper institutional governance and the creation of trusted, consistent networks. Usually African scientists leading clinical trial sites can apply for funding to conduct a trial; if the site is well known the scientists may be approached by a sponsor such as a pharmaceutical company interested in conducting a trial.

Clearly this approach takes time and usually benefits well-known sites or triallists. Key stakeholders should work together to expedite the rollout of trials in different countries. This would include inter-country collaborations such as working with different governments and scientists in co-designing trials; and providing harmonised guidelines on patient management, sample collection and tracking and sharing results in real time. African governments, meanwhile, should provide additional funding to clinical research institutions and clinical trial sites.

This would allow the sites to pull resources together and rapidly enrol patients to answer various research questions. Because of the uneven distribution of skills and resources the continent should also adopt a hub-and-spoke model in its efforts.

Governments should also form a task force to quickly engage with key pharmaceutical companies with drug candidates for COVID Through all of this, it is necessary for stakeholders to identify and address key ethical issues that may arise.

Ethics should not be compromised by haste. This would require governments on the continent to evaluate their role and level of investment in the general area of clinical trials.

This will augment the quality and quantity of clinical trials in the face of the constant challenge of emerging and re-emerging infectious diseases as well as a steady rise in non-communicable diseases. On top of this, clinical trial centres, clinical research institutions and clinical triallists on the continent should strive to increase their visibility in the global space. Despite Africa's growing cancer burden, individuals of African descent, notably those residing in Africa, remain drastically under-represented in cancer clinical trials.

Two recent summits-the 1st All Africa Clinical Trial Summit and the Operational Strategy for Clinical Trials in Nigeria Summit-convened experts from governments, the private sector, universities, and professional societies to define the barriers to Africa's participation in multicenter clinical studies and the strategies to eliminate those impedances.

Methods: The discussions held during the two clinical trial summits were condensed into a set of 10 recommendations covering five broad categories funding, regulation, capacity building, Africa-centric approach, and patient engagement.

In this article, four programs are presented as examples of how the summits' recommendations can be put into practice to improve Africa's ability to attract clinical trials, in particular, cancer clinical trials. Results: These example programs all leveraged a multilateral, Africa-driven approach to building Africa's clinical trial capacity, increasing visibility of Africa's current clinical trial capabilities and priorities, improving regulatory infrastructure and enforcement on the continent, and optimizing patient and clinician engagement strategies.