Email Updates

Search form

You are here

From Results to Delivery

After the Results

Out of the many candidates that enter preclinical or clinical testing, only a handful will show safety and benefit in large-scale studies. Such candidates will be considered for approval and eventual introduction and rollout. The rollout, or program implementation, process is long and complex. There are many steps along the way, some of which take place while clinical trials are ongoing. These various steps are outlined below.

Implementation steps that start once trial results are in:

Licensing and Regulatory Approval

"Licensing" refers to the steps that a country takes to legally allow a vaccine, medication or other health product to be marketed or distributed within its borders. A product is licensed on the basis of the information provided by the developers, including data from preclinical and clinical trials and ensuring the quality of the manufacturing process. Product licensing also considers what the product label will say about what the product does or does not do, any warnings about side effects, use in pregnant women, etc. The licensure process is completed by regulatory agencies. The US Food and Drug Administration and the European Medicines Agency are two such bodies. Many developing countries also have regulatory agencies that consider product information and may also look to guidance from WHO in making their decisions.

Pilot Projects or Pre-introductory Studies

Pilot and pre-introductory projects can be designed to learn more about an intervention and can happen while the regulatory approval process is underway, and before it is completed. These projects are usually relatively small (i.e., providing a new strategy to a defined community, not an entire country). They may look at different strategies for delivering or communicating about the intervention and other issues.

Phase IV studies take place after a strategy has been approved or licensed. These studies generally focus on tracking large numbers of people as they use the strategy to see if there are any issues that were not found in earlier clinical trials, like rare events, long-term safety issues, or effects on a particular population of users. These studies help to learn more about how a strategy works in the "real world" outside of the clinical trials setting. These studies may happen over a longer period of time and enroll a larger volunteer population than do Phase III studies. They can help identify rare side effects or drug interactions.

Operations Research

Operations research refers to a range of studies that look at how to introduce and deliver a new strategy; how to add it to existing prevention or other health programs; logistics questions; what kinds of providers and information are best; and how to sustain and improve on these programs as access to the new intervention expands during the rollout (program implementation) process. Operations research can be designed to address a wide range of questions and can be done over the course of many years. This research is one way that programs can become more effective and efficient at making health innovations available to people in different settings or population groups.