OBJECTIVES
(i) To discuss the importance of conducting oncology clinical trials in Africa.
(ii) Discuss the benefits of conducting clinical trials to the health care system and to the patients.
(iii) Discuss the challenges noted with oncology clinical trials.
OUTLINE
1. African Cancer Tumor Burden.
2. Involving patients on African Ancestry in clinical trials
3. Design of clinical trials to fit African population.
4. Blue print of conducting clinical trials in Africa using Nigeria as a case study.
5. Benefits of conducting clinical trials
6. Logistics to conducting trials in Africa
7. Challenges to trials
8. Future Direction.

Although a lot of research is going on in the developed world in the field of oncology, Low and Middle Income (LMIC) countries especially in Africa continue to lag. This is partly due to the myths that Africa being a ‘dark continent’1 does not have what it takes to do drug development like the developed countries. In addition, the impression the world has of Africa is that of poverty, drought and disease-stricken continent2. The Economist, over the years ran Editorials on its front cover in 2000 referring to Africa as ‘the Hopeless Continent’. Over the years, there was a new perception and the headlines changed to ‘’Aspiring Africa in 2013’’ and finally to ‘’Science in Africa -on the rise in 2014’’ 3. Now that it is well known that Science is on the increase, it is time to start looking to developing drugs in Africa or at least, start being part of global drug development that leads to Market Authorization and Approval (MAA). However, we need to be clear on the basics of drug development and the requirements.
The world is looking to the emerging markets, including Africa, in the development of new drugs and new targets due to high attrition rate and high competition for the same patient pool in the developed countries. Therefore, we need to take the bull by the horn, if we want the world to take us seriously and be a player in the drug development field by doing the right things and following the existing guidelines. So, what is drug development? Drug development simply is the journey from the Bench (laboratory) to the Patient. It involves putting tens of thousands of compounds through series of processes that end up with only one compound being licensed and getting to the Patient. It is a long and expensive process.
It takes 10-12 years and about $2-3billion dollars to develop one compound, and even more if we talk about the new drugs such as Immuno –oncology drugs4.
There are four main stages to drug development5 governed by international guidelines such as GLP (Good Laboratory Practice)6 and GCP (Good Clinical Practice)7. GLP is to make sure preclinical activities are carried out to the high standard expected by the international community. Clinical trials that must be used for marketing authorization, must be conducted in line with the 13 principles of GCP. This gives the assurance that the rights, safety and well being of trial subjects are protected and the clinical data generated are credible. Though the economies of African countries are on the increase, there is a rise in middle and younger population who have more disposable income and growing awareness of health issues globally, Drug development is an expensive business and it might be challenging to African countries to finance it alone.
Therefore, there are opportunities for capacity building and partnership with pharmaceutical companies if we can prove that data generated will be credible and GCP compliant. These have been done successfully in the Vaccine and Infectious diseases arena as shown by GlaxoSmithKline (GSK) mission of investing 20% of its profit for capacity building 8. The huge population with advanced diseases such as Prostate cancer and Triple negative breast cancer (TNBC), with high prevalence in Africans and those with African descent are also advantages that can be used for the benefits of patients in Africa so that these patients can have access to cutting edge drug development. The main challenges are limited resources, corruption, cultural biases and practices. Many patients with advanced disease present late and illiteracy makes informed consent difficult in most countries in Africa. However, these challenges are not insurmountable. In keeping with the Economist editorial in 2014, science in Africa is on the rise, and the words of Dr Kwame Nkrumah, Ghana’s first post-independence President, ‘’we face neither East nor West: we face forward’’9. In summary, drug development is a multidisciplinary and expensive business. Capacity building and Partnership is the way forward to ensure that the right trainings are given. See one, Teach one. Let stand together, though many countries, but one continent to debunk the myth.