When the next pandemic hits, the world will demand speed and reassurance. Vaccine development will accelerate, governments will push for rapid rollout, and communities will ask a critical question: is it safe?
Long before that moment arrives, independent experts are already working behind the scenes to help ensure the answer is yes.
The Task Force’s Brighton Collaboration, with support from the Safety Platform for Emergency vACcines (SPEAC), is training a new generation of leaders for Data and Safety Monitoring Boards, or DSMBs. These independent groups oversee vaccine trials, helping ensure they remain safe, ethical, and scientifically sound. As data emerges, they review it carefully and provide independent recommendations on whether a trial should continue, pause, or stop.
For the people doing this work, the responsibility is both technical and deeply human.
“This training opens and closes with the patient’s safety at the center. Therefore, it shapes our scientific ambitions to be ethical and lawful,” said Dr. Bongile Mabilane, who completed the Brighton training course. As a Clinical Safety Physician at the Hutchinson Center Research Institute of South Africa, Dr. Mabilane manages vaccine trial safety for COVID, HIV, and TB. “Through detailed case studies, the training helps us learn from the past, ensuring we are prepared to navigate and avoid common mistakes in the future. I also like the continued education it provides on the issue of autonomy, independent reviews, and conflicts of interest. These are governance terms that do not get covered in conventional medical classrooms.”
For Dr. Robert Chen, Director of the Brighton Collaboration, building this kind of expertise is essential to improving health outcomes worldwide. “Well-designed and executed clinical trials are essential for the generation of scientific evidence needed to improve medical care and public health,” he said. “Historically, there have been relatively few clinical trials in low- and middle-income countries, and a lack of formal training for DSMB members. The SPEAC-sponsored DSMB training* helps to fill this gap.”
Strong, independent oversight does more than protect trial participants. It also helps decisions happen faster and with greater confidence. When potential issues are identified early, trials can adapt quickly, reducing the risk of delays that can slow an outbreak response.
Dr. Alemayehu Duga, Senior Technical Officer at the Africa CDC, also participated in the training. He highlighted that the program strengthens emergency preparedness by building capacity in the principles and functioning of DSMBs, particularly in safeguarding clinical trial conduct during public health emergencies.
“DSMB training creates awareness and reinforces the critical role of independent oversight in clinical trials. Such an initiative contributes to emergency response preparedness by creating a workforce that understands how to ensure participant safety, maintain data integrity, and uphold the overall validity of studies, enabling countries and institutions to act more efficiently while adhering to high ethical and scientific standards.”
Photo credit: Dr. Alemayehu Duga
The role of DSMBs is often misunderstood. Trials are not only paused for safety concerns. They may also be stopped early when a treatment proves highly effective. In those cases, continuing the trial with a less effective option would no longer be appropriate.
“By halting the trial early for efficacy, researchers can ensure that all participants, and eventually the broader public, receive the superior drug or vaccine as quickly as possible,” said Dr. Mabilane.
Participants say the training not only strengthens technical skills but also highlights the real-world impact of every decision. “It was very important for me to learn that decisions made by DSMBs are not based only on numbers, rules, or statistical information; they also involve careful discussions and considerations for real-world consequences for populations and individuals,” said Dr. Prince Agyapong, a clinical research physician with experience in clinical trials, safety monitoring and reporting at the Kintampo Health Research Center in Ghana. “I was thrilled to learn from experts from different parts of the world and join practical discussions that deepened my understanding of DSMB activities.”
Interest in the program is growing, driven by an increase in outbreak-related trials and greater public attention on vaccine safety following COVID 19. Attendance has more than doubled since the program began in 2021, with 40 participants attending the most recent session and more than two dozen of those graduating with certification.
“I believe demand has grown quickly because of several factors. There are now more vaccine trials related to outbreak response. Also, vaccine safety decisions have come under much greater public scrutiny after the COVID-19 outbreak, increasing the need for this training resource,” said Dr. Agyapong.
As global health priorities continue to shift, the need for trusted, well-trained oversight is only increasing. For those working behind the scenes, the goal is simple but essential. When vaccines reach the public, they must be not only fast but safe, ethical, and worthy of trust.
*The SPEAC project has been funded in whole by CEPI
