Table 2.
Logic model of RWE development in FDA, EMA, and NPMA.
| DRAs | INPUTS | ACTIVITIES | OUTPUTS | OUTCOMES | |
|---|---|---|---|---|---|
| What DRAs invested | What DRAs did | Who DRAs reached | What DRAs got | What DRAs achieved | |
| FDA | Aim: “Utilizing Real World Evidence.”: supporting the approval of new indications for approved drugs and post-approval research requirements | ||||
| · Staff and experts · Financial · Technology · Equipment and platform. · Community · Domestic and international partners |
· Conduct workshops and meetings · Provide project findings · Together stakeholders · Develop reports, curricula, resources · Facilitate access to information · Work with partners |
· Industry · Academic institutions · Domestic government institutions · Overseas institutions |
· Publications and reports · Regulatory guidelines · Database and data sharing platforms |
· Decision-making: ∙ New drugs approved · Awareness · Knowledge · Skills · Motivations · Behavior · Health · Social · Economic |
|
| EMA | Aim: Utilizing the power of big data and improving the application of high-quality RWD to support regulatory decision-making | ||||
| · Staff and experts · Financial · Committee · Technology · Resources and organization |
· Conduct workshops and meetings · Organize initiatives · Together stakeholders · Facilitate access to information · Work with partners from different countries |
· Industry · Academia · Agencies and community · Decision-makers · EU country health institutions · Overseas institutions |
· Publications and reports · Centers and committees · Tools developed by activities. · Annual conference reports · Database and data sharing platforms |
· Decision-making: ∙ New drugs approved and indications added. · Communications · Motivations · Behavior · Health · Social · Economic |
|
| NMPA | Aim: Utilizing the power of big data and improving the application of high-quality RWD | ||||
| · Financial · Technology · Domestic partners |
· Conduct workshops and meetings · Organize projects · Together stakeholders · Facilitate access to information · Leadership in local institutions |
· Industry · Academia · Local institutions |
· Publications and reports · Regulatory guidelines · Regulatory Science Action Plan |
· Decision-making: ∙ New devices approved and indications added. · RWE platform · Motivations · Health · Social · Economic |
|