Regulator tightens clinical-trial rules as new applications fall

 

There are 134 clinical trials under way in the country, with half focused on tuberculosis, HIV and malaria, according to the Pharmacy and Poisons Board.

 

But fewer new studies are being submitted to the medicines regulator. The Board received 76 applications in 2023, 73 in 2024 and 59 in 2025. It received 40 in the first eight months of this year.

 

The fall comes as the regulator changes how clinical trials are reviewed, including a new system intended to cut the time researchers spend waiting for approvals.

 

On 17 August, the Board began a 12-month pilot allowing researchers to submit a clinical-trial application at the same time to the regulator and a participating ethics committee. Previously, researchers had to obtain ethics approval before submitting the application to the Board.

 

The change follows discussions between the Board and the Clinical Research Society of Kenya, which is led by Prof Walter Jaoko. At a meeting in July, the two sides discussed delays in starting trial sites and a proposed parallel review system, according to the Board.

 

The time taken to get a study from approval to the start of recruitment has been a longstanding concern.

 

A study at Aga Khan University that examined clinical-trial activation between 2020 and 2022 found that non-Covid studies took an average of 259 days from regulatory submission to site activation. Covid-related trials took 80 days.

 

The researchers pointed to the sequence of ethics and regulatory reviews as one of the barriers to starting studies and said the experience during the pandemic showed what could be achieved when reviews were conducted in parallel.

 

The changes are also being made against a wider problem in African clinical research. The continent carries nearly a quarter of the world’s disease burden but accounts for about 2% of clinical trials, according to a study published in Nature Medicine this month.

 

The study examined clinical-trial regulation and ethics review in Kenya, Rwanda, Tanzania, Nigeria and Zimbabwe. It found that coordinating the two processes and allowing them to run in parallel produced some of the fastest improvements in trial readiness.

 

Of the 134 active trials, 67 are in tuberculosis, HIV and malaria. A further 47 concern chronic diseases, including cancer and hypertension. Twelve involve medical devices and eight involve vaccines, according to the Board.

 

Non-communicable diseases now account for 43% of deaths and nearly half of hospital admissions, according to the Ministry of Health.

 

The clinical-trial registry shows studies covering a wider range of conditions, including sickle-cell disease, cancer, premature birth and sexually transmitted infections. Some are being conducted at sites outside Nairobi, including in Kisumu, Siaya, Uasin Gishu and Mombasa counties.

 

The malaria vaccine programme provides one example of what clinical research can produce.

 

Kenya was one of three countries where the RTS,S malaria vaccine was introduced through a programme that reached more than 2 million children between 2019 and 2023.

 

An evaluation published this year found that the programme was associated with a 13% reduction in mortality among children eligible for vaccination. The findings added to the evidence behind the World Health Organization’s recommendation of RTS,S and its subsequent recommendation of R21, another malaria vaccine.

 

The two vaccines are now recommended by WHO for the prevention of malaria in children.

 

For participants, the end of a trial can bring a different question: what happens when the study ends but the treatment is still helping?

 

The clinical-trial rules require researchers to include a post-trial access programme in the study protocol. The provision is intended to give participants continued access to an investigational medicine before it receives marketing authorisation where the treatment has proved beneficial. The requirement is also set out in law.

 

One trial listed in the regulator’s public registry provides for participants who continue to benefit from a long-acting HIV treatment to receive it for up to four years after the study, or until the treatment is registered and reimbursed locally, the development programme ends or the participant no longer benefits.

 

The Board revised its clinical-trial guidelines in June, the sixth revision of the framework. The new version incorporates the International Council for Harmonisation’s Good Clinical Practice standard, ICH E6(R3), and sets out requirements covering trial monitoring, safety reporting, protocol amendments, progress reports and access to source data and documents. Researchers must also report protocol deviations and violations, challenges encountered during a study and its current status.

 

Ahmed Mohamed, the Board’s chief executive, said some of the requirements were already being applied and that the revised guidelines clarify them.

 

The Board says its aim is to improve the regulatory environment while avoiding unnecessary delays in approving trials.

 

The concurrent-review pilot will test whether one of those delays can be removed.