Engaging people from a nomadic community in rural Kenya in a clinical trial involved employing community mobilisers on motorbikes and understanding seasonal and cultural practices.

Geographic touchpoints such as waterholes and schools were mapped as places to find trial participants as they searched for grazing and water for their cattle and goats.

This was a lot of work, but for Luke Kanyangareng, a nurse based in rural West Pokot, adjacent to the Ugandan border, the community is the main stakeholder in clinical trials.

“Clinical trials are about getting a solution to their health problems, so we need to recruit and keep rural patients in the trial,” said Kanyangareng, who recently won an international award for his role as a patient advocate.

“Understanding their life setup is also very important, because when you are doing recruitment, you should know where this patient is coming from, and where you expect to find this patient at different seasons of the year.” 

Kanyangareng was addressing a September 16 webinar on patient and community engagement in clinical trials.  The webinar, hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)  was the first such event in a series of four, comprising this year’s African Regulatory Conference.  The online conference focused on advancing the clinical research ecosystem continues this autumn until 25 November. 

‘Not optional’

Dr Tariro Makadzange, the CEO of the Africa Clinical Research Network, described community engagement in clinical trials as “fundamental not optional”. 

“Africa has not been a key player in clinical trials. We currently only participate in 3% of global trials, and yet, we’re 18% of the global population,” said Makadzange.

The Africa Centres for Disease Control and Prevention (Africa CDC) is trying to improve this statistic, according to Dr Mosoka Fallah, acting director of the body’s Science and Innovation Directorate.

“Africa is very vulnerable to disease outbreaks due to the fact that our research and development (R&D) capacity is very limited,” said Fallah. “We have developed a clinical trial R&D blueprint, working along with many other partners.”

Dr Janet Byaruhanga, from the African Union’s development agency, AUDA-Nepad, spearheads a programme aimed at ensuring the continent can produce certain priority medical products by 2050???

“The Pharmaceutical Manufacturing Plan for Africa is the blueprint for advancing local capabilities on the continent to produce medicines for the diseases of concern,” said Byaruhanga.

“We have prioritised a list of 24 medical products that we want the continent to be self-reliant in producing,” she added, engaging in a product-by-product approach.

Producing paediatric Praziquantel to treat schistosomiasis and medicines to address post-partum bleeding in women after birth are some of the priorities.

“We support the member states and the regional economic communities to create an enabling environment for the manufacture of these producta, and provide advisory services to industry.

“It will be very important for us to ensure that our community health care programme is linked with the local manufacturing programme to engage communities,” she added.

‘People First’ approach

Joy Malongo is the access manager at Drugs for Neglected Diseases Initiative (DNDi), the non-profit organisation that develops affordable treatments for neglected tropical diseases (NTDs), particularly for marginalised communities. 

DNDi’s approach involves “systemic community engagement” across all R&D phases, guided by a “people first” approach, said Malongo.

“Patient and community engagement helps identify and respond to barriers faced by marginalised groups, encourages a team approach that reduces disparities in access and outcomes, and empowers communities to advocate for their health rights.”

Norest Beta, the coordinator of clinical trials and community engagement at Africa Clinical Research Network, says communities need time to “understand, process and accept” clinical research. 

“Rather than rush engagement, we need to give them time to ask questions, question the research agenda, and hold us accountable,” said Beta.

But, as Waila Mukulu from Science for Africa Foundation says, theer often isn’t the budget to engage with communities.

“When there’s a need to cut down on the budget, community engagement activities are usually the first ones to go because there’s a feeling that the interest is the science,” said Makulu.

“We really emphasize to our researchers that it is important to ensure that we are actually meeting the needs of the African continent in whatever we are doing, and you will only be able to do this if you engage communities meaningfully and ensure that any research that we are conducting, is actually a reflection of their needs and priorities.”

Early engagement

Dr Huwaida Bulhan, scientific operations lead at Roche, said that patient and community engagement is” embedded throughout the clinical journey” at her company.

“We’re really engaged with patients and patient advocacy groups right from the study design stage,” said Bulhan, who also represented the IFPMA at the webinar.

“They advise us on endpoints that actually matter to patients”, said Bulhan, including how to make trial procedures less burdensome, especially for under-represented groups like women and young people. 

“Decentralised trials, hybrid trial models, and digital tools have worked very well in sub-Saharan Africa, with practical support like transport, care conditions and flexible scheduling for patients,” she added.

“We work very closely with local patient organisations, healthcare providers and community leaders, and these trusted networks help us understand the cultural context, how to reduce stigma, and how to create the right engagement strategies that resonate with people where they are.”

Roche also invests in health literacy for patients and healthcare providers to demystify clinical trials.

“We look at community engagement as a long-term commitment that does not stop when the trial ends,” Bulhan stressed.

“We share trial results with participants and communities where we’re able to do so. We also work to ensure that patients can access the innovations that emerge from this research. 

“The research is not effective if it’s not actually reaching the patients who need them,” added Bulhan.

“It really is about moving from that transactional relationship that a lot of people have in mind when they think of private industry, to a long term partnership that is rooted in trust and shared benefit.

“Patient and community engagement is what transforms clinical research from being about data collection to being about people, and when we do it well, then everyone benefits. Patients feel respected and communities see the lasting value of everything that we do.”

The IFPMA is hosting a four-part Africa Regulatory Conference webinar series from September to November 2025 that is open to all who are interested. The next webinar, on 2 October, deals with underrepresented populations in clinical trials.

Image Credits: UNFPA.