A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings
- 1Food and Drug Administration, Silver Spring, Maryland, USA
- 2Food and Drug Administration, Office of Pediatric Therapeutics, Silver Spring, Maryland, USA
- Correspondence to Dr Patricia L Bright, Food and Drug Administration, 10903 New Hampshire Ave, WO51-6272, Silver Spring, MD 20993-0002, USA;
Contributors There are no other contributors besides the two authors. PLB generated the idea, reviewed the prior literature, conducted the analysis, proposed the model and drafted the manuscript content. RMN contributed to the manuscript organisation, analysis, decision tree, justification and manuscript editing.
- Received 6 September 2011
- Revised 24 February 2012
- Accepted 4 March 2012
- Published Online First 5 May 2012
A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure. The model lends itself to a decision tree that can be adapted to the local context and resources so as to provide procedural guidance. This approach can help in planning and establishing organisational policies that govern the provision of ancillary care.
The opinions expressed in this paper are those of the authors and do not necessarily represent the policies of the Food and Drug Administration or the Department of Health and Human Services.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.