Aligning new interventions with developing country health systems: target product profiles, presentation, and clinical trial design.
Many new interventions are being created to address health problems of the developing world. However, many developing countries have fragile health systems and find it difficult to accommodate change. Consequently, it is essential that new interventions are well aligned with health systems and their users. Establishing target product profiles (TPPs) is a critical, early step towards tailoring interventions to suit both of these constituencies. Specific analyses can help identify and establish relevant TPP criteria such as optimal formulation, presentation and packaging. Clinical trials for a new intervention should be designed to address both TPP-specific questions and anticipated use of the intervention in target countries. Examples are provided from research on malaria vaccines that are also applicable to other new public health interventions.
PATH Malaria Vaccine Initiative, Ferney-Voltaire, France.
Alan
A
Brooks
Julia K
JK
Nunes
Andrew
A
Garnett
Robin
R
Biellik
Didier
D
Leboulleux
Ashley J
AJ
Birkett
Christian
C
Loucq
D002986:Clinical Trials as Topic; D003153:Community Health Services / Q000458:organization & administration*; D003659:Decision Making, Organizational; D003906:Developing Countries; D006285:Health Planning / Q000458:organization & administration*; D006801:Humans; D017589:Immunization Programs; D011050:Policy Making; D012107:Research Design