Trial Readiness Is Not a Status. It Is an Execution Condition.
In clinical research, few words carry more operational risk than “ready.” A site may be described as ready when a Research Ethics Committee or Institutional Review Board has approved the protocol. A network may be described as ready when a master agreement is in...
Optimising regulation and ethics in research | ACRN Podcast EP08
In this episode, we go behind the scenes of clinical trial start-up to explore what happens before the first participant is enrolled. ACRN CEO Dr Tariro Makadzange and Regulatory Affairs Officer Knowledge Ushamba discuss the regulatory, ethics, and operational systems...
Negotiating Power in Global Clinical Research: Why Institutional Strength Matters More Than Bargaining
For decades, discussions about equity in global clinical research have often focused on the terms of partnership, who owns the data, who leads publications, who holds intellectual property, and who captures the economic value created by research. These are important...
Scaling Clinical Trials in Africa: What System Integration Actually Requires
Most scaling plans for clinical research in Africa describe expansion. Fewer describe integration. Expansion adds sites, countries, investigators, and trials. Integration is the harder work of making those additions function as a single operational system. The...
Ebola Bundibugyo: Africa’s Wake-Up Call for Science and Preparedness | ACRN Podcast EP06
The latest episode of the ACRN Podcast tackles one of the most pressing public health stories on the continent today: the ongoing Bundibugyo Ebola outbreak and what it reveals about Africa’s readiness to respond to emerging infectious disease threats. In Episode...
Regulatory Readiness Is Not the Same as Regulatory Delay
When a clinical trial in Africa stalls, the explanation is often immediate: “regulatory delay.” It is a convenient phrase. It is also too often an incomplete one. “Regulatory delay” can mean many different things. It can mean a regulator took longer than expected. It...
From Participation to Priority: When African Clinical Trial Sites Become Strategically Indispensable
Strategic relevance in global clinical research is not granted. It is earned. Every sponsor has a line in its portfolio strategy. Above that line sit the countries and sites trusted with pivotal trials, adaptive designs, first-in-human studies and complex oncology...
What Sponsors Actually Need from African Trial Networks
By now, the argument for Africa’s inclusion in global clinical research is well established. The scientific rationale is clear. The public health need is clear. The access imperative is clear. But sponsors do not place complex Phase II and III trials solely on the...