ATTENTION!!! SPONSORS AND CRO’s. WHY YOU NEED TO CONSIDER CONDUCTING A CLINICAL TRIAL IN UGANDA?

Uganda has an estimated total population of 49, 346, 548. Uganda is a member of the East African Community?(EAC), along with Kenya, Tanzania, Rwanda, Burundi, Democratic Republic of Congo (DRC) and South Sudan.

The country is bordered to the east by?Kenya, to the north by?South Sudan, to the west by the?DRC, to the south-west by?Rwanda, and to the south by?Tanzania.?Generally, Uganda is a politically stable country with a few pockets of insecurity like there is in any country.

Owing to the large number of communities, culture within Uganda is diverse. Sponsors seem to be missing out on the opportunity to conduct comparatively cheap research with a diverse patient population, often enrolling patients who have never experienced any treatment for their ailment.?

Definitely, lack of clinical research could mean a lack of suitable medicines. Knowing that some diseases are more prevalent in certain ethnic groups, and that genetic makeup can factor greatly in a person’s response to treatment.

While infectious diseases may command the most attention, the country also experiences a significant burden of non-communicable disease (NCDs). Cancer now kills more Ugandans than malaria, while conditions like type 2 diabetes and cardiovascular disease are on the rise due to rise in consumption of fast foods and sedentary lifestyle especially among urban dwellers.??

Certainly, this calls for more clinical trials in a country with a well-developed pool of investigators, diverse, fast growing and young population which has a high interest in clinical trials since it could be the only way to may be access the available medicine/treatment.

This would also mean that instead of being end users of the products tested somewhere else that may end up causing Adverse events.?

The risk factors that drive the most deaths are metabolic, environmental/occupational and behavioral combined. According to WHO international clinical trials registry platform, only (1,030) 0.15% of clinical trials are being conducted in the Uganda in relation to 160,000 clinical trials across the globe, this simply indicates a virgin area with a clinical trial na?ve population.

Interestingly, most sites in the country have all of the staffing, infrastructure and systems to actually manage a clinical trial appropriately. The country has invested more heavily in her overall research and development capacity and developed the infrastructure necessary to host and manage clinical trials through partnerships with different funders or implementing partners.

I will profile sites (upon request by willing the sponsor/CRO via LI inbox or [email protected] ) across the country to showcase everything from their laboratory capability and their support staff experiences all the way down to their leader management processes.

So, what are the regulatory processes/requirements?

The participation of humans in clinical trials in Uganda is overseen at the institutional level by the Institutional Review Board (IRBs), and at the national level by UNCST.

The UNCST liaises with the Research Secretariat in the Office of the President, for national security reasons, to clear researchers to undertake their projects in Uganda.

For clinical trials, an additional requirement is to obtain the NDA’s authorization to import and/or use the trial drug/device in Uganda. The NDA regulates the conduct of clinical trials as per section 40 of the National Drug Policy and Authority Act, 2000 edition. The steps involved in conducting clinical trials in Uganda are depicted in the picture attached to this article.

The application to conduct a clinical trial in Uganda has to be submitted in a clinical trial application format (available at?https://www.nda.or.ug) to the Executive Secretary/Registrar of the NDA.

The application should be accompanied by complete, legible copies of key (peer-reviewed) publications supporting the information. The NDA requires approval from the IRB and registration with UNCST before arriving at a decision to conduct any clinical trial.

The applications for conducting a trial are judged on four ethical research principles that include respect for persons, beneficence to research participants, nonmaleficence, and justice.

The application should be accompanied by the other relevant documents (to be provided to the willing sponsor/CRO upon request via my LI inbox or [email protected]).

The IRB has to respond with a decision within 60 days of submission of the application for approval.

The fees for regulatory submissions can be found on the website of respective the regulatory bodies.