The long-awaited second episode of the Breakthrough Clinical Trials Lounge has finally been released! Hosted by Dr Breakthrough herself, Dr Nyeleti Bicky Mthombeni, your chosen voice for Africa's clinical trials community, we take you on a journey to amplify Africa's clinical trial story and unveil the continent's expertise.
In this episode, we tackle tough questions and vital information, including the public’s general understanding of clinical trials in Africa. Clinical trials are research studies conducted with human participants worldwide to generate data on whether a medicinal product or medical device works.
We focus on three key categories of individuals: Those less knowledgeable about clinical trials: The public, whom we would like to educate about the vital role of clinical trials. The experts: This group includes regulators (like South Africa's SAPRA or Nigeria's NAFDAC), project managers, and qualified medical doctors (researchers) who conduct trials. The decision-makers: pharmaceutical companies, biotechnology companies, non-governmental organisations, governments, and other organisations that determine where a clinical trial should be conducted and where data should be collected. Why it matters: Africa currently accounts for less than 5% of clinical trials, which is why this platform was launched to inform the community and the global community that Africa has the expertise to do more.
Dr Breakthrough shares two powerful cases of real participants who enrolled in clinical trials:
Patient 1 (Rheumatoid Arthritis): A 60-year-old lady who considered participation a "privilege" because her standard treatment was not working. The trial was a positive experience, enabling her to lead a productive life.
Patient 2 (Diabetes): An older patient (above 50 years) who participated in a diabetes study for over eight months primarily because he wanted to help someone else and generate knowledge for future patients. We also explore a hypothetical case study of "Khensani", a patient diagnosed with a rare disease (e.g., Duchenne muscular dystrophy [DMD]) for which we make an assumption that no treatment is available, making a clinical trial the only option. We also dive into how to find Clinical Trials using different databases
We demonstrate how to find trials using resources like:
• The South African National Clinical Trials Registry
• The Pan-African Clinical Trials Registry
• Centerwatch.com (easy access tool)
We delve into the Clinical Trial Process We invite those that do not know where to begin, to learn about the essential steps once you decide to join a trial: Informed Consent: Researchers explain the trial, the risks, and what is being studied, ensuring you are fully informed before participating. Eligibility Process: Researchers determine if you qualify for the trial based on specific criteria. We further break down the phases of clinical trials to clarify how they work. Trial Phases: We break down the drug discovery process, starting with laboratory work, then moving to animal studies, and finally to human trials: Phase 1 (First-in-Human), Phase 2, and Phase 3.