Scientists are calling for clinical trial approval processes to be streamlined during health emergencies, arguing that lengthy procedures can delay the testing of vaccines and treatments when lives are at risk. Prof Bruce Kirenga, who leads the Interdisciplinary Consortium for Epidemics Research and Response (ICER), says clinical trials should not be made unnecessarily complicated or prolonged simply to satisfy regulatory requirements.
He said this is particularly important during disease outbreaks, when researchers are racing against time to find treatments and vaccines. Kirenga said some vaccine trials may not always need to go through all three conventional phases where there is already substantial information about the pathogen and the product being tested.
Kirenga was speaking on Monday at the launch of a more than 12-million-euro project aimed at strengthening Africa’s capacity to conduct clinical trials during disease outbreaks. The five-year project, known as ACT-PREP, or Advancing Clinical Trials and Epidemic Preparedness Research Capacity in Africa, will involve ten African institutions and train more than 700 specialists.
Kirenga said the project comes at a time when Ugandan scientists are contributing to research during the Ebola outbreak in neighbouring Democratic Republic of Congo. He said researchers currently have seven protocols being studied in the Democratic Republic of Congo, including a new antiviral drug whose trial began recruiting participants about two weeks ago.
Kirenga, who is also the Executive Director of Makerere University Lung Institute, said the experience in the Democratic Republic of Congo demonstrates the need for countries to have the capacity to rapidly organise and conduct clinical trials when outbreaks occur.
Prof Rhoda Wanyenze, Dean of Makerere University School of Public Health and scientific lead for ACT-PREP, said Africa urgently needs to strengthen its clinical trial capacity because the continent experiences a high burden of disease outbreaks but has relatively limited capacity to conduct trials.
She said the project will help build a network of researchers and institutions capable of responding more quickly to emerging and re-emerging diseases. Wanyenze said countries such as South Sudan and Somalia could also draw lessons from Uganda’s experience in disease surveillance and mounting an early response to outbreaks.
The push for faster approvals, however, comes with concerns about maintaining safeguards for people who participate in clinical trials.
Dr Daniel Kyabayinze, Director of Public Health at the Ministry of Health, urged researchers to anticipate cultural and political concerns before starting clinical trials rather than treating them as issues that emerge after a study has begun. He said communities must be involved early because public attitudes can influence whether people accept new vaccines and treatments.
Kyabayinze cited the COVID-19 pandemic, when a video posted on social media raised doubts about the Moderna vaccine and contributed to vaccine hesitancy.
He said researchers therefore need to understand the social and political environment in which clinical trials are conducted and engage communities before interventions are introduced. The Uganda National Council for Science and Technology says some of the delays associated with clinical trial approvals are already being addressed through joint reviews involving different regulators.
Dr Hellen Opolot, Assistant Executive Secretary at the council, said the joint review process brings together regulators including the National Drug Authority and the Uganda National Research Organisation, reducing the time researchers have to wait for decisions. She said protocols can now be approved in as little as ten days where reviewers have no queries.
Opolot, however, cautioned that the need for speed during epidemics does not remove the requirement to protect research participants.
She said researchers must continue to follow the required procedures, including obtaining informed consent from participants. As Africa seeks to expand its ability to conduct trials during outbreaks, scientists at the ACT-PREP launch were also urged to address other challenges that can delay research.
These include difficulties accessing trial products, poor data sharing between countries and limited sharing of information among researchers. Such gaps can delay the start of clinical studies and, ultimately, the availability of evidence needed to guide the response to outbreaks.
The ACT-PREP project is intended to strengthen the institutions, researchers and systems needed to conduct clinical trials more efficiently across Africa, while maintaining the ethical and regulatory safeguards required to protect participants-URN. Give us feedback on this story through our email: kamwokyatimes@gmail.com
