Practical issues in relation to clinical trials in children in low-income countries: Experience from the front line

Archives of Disease in Childhood

Volumn 97, Issue 9, 2012, Pages 848-851

  Molyneux, Elizabeth ^a   Mathanga, Don ^a   Witte, Desiree ^b   Molyneux, Malcolm ^a  

^a UNIVERSITY OF MALAWI   (Malawi)

^b UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CAPACITY BUILDING; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); COMMUNITY; DEVELOPING COUNTRY; FOLLOW UP; HEALTH CARE POLICY; HEALTH SERVICE; HUMAN; INFORMED CONSENT; LOWEST INCOME GROUP; PATIENT COMPLIANCE; PERSUASIVE COMMUNICATION; PRIORITY JOURNAL; REIMBURSEMENT; REVIEW; STUDY DESIGN; TRAINING; WORKLOAD;

CHILD; CLINICAL TRIALS AS TOPIC; COERCION; DEVELOPING COUNTRIES; HUMANS; INFORMATION DISSEMINATION; INFORMED CONSENT; INTERPROFESSIONAL RELATIONS; MEDICALLY UNDERSERVED AREA; PATIENT SELECTION;

EID: 84866115028     PISSN: 00039888     EISSN: 14682044     Source Type: Journal    
DOI: 10.1136/archdischild-2011-301476     Document Type: Review

References (14)

1. Use of Standards in Paediatric Clinical Trials in Developing Countries. Report of meeting held in Amsterdam,The Netherlands October 28th 2009 http://www.who.int/childmedicines/progress/Amsterdam-Meeting.pdf (accessed February 2012).
2. Challenges in the Conduct of Pediatric Trials in low and middle income countries. 2nd StaR report. Meeting held in Vancouver Canada Sept 12th 2010 One of a series of meetings. "Challenges in Conduct of Paediatric Clinical Trials in Low and Middle Income Settings" Webcast A, Webcast B, Webcast C, Webcast D, Webcast E, Webcast F, Webcast G, Webcast H, Webcast I. http://phsa.mediasite.com/mediasite/Viewer/?peid= 98604b2f75d7410896790dcfbb0e56b61d (accessed February 2012).
3. Schull MJ, Banda H, Kathyola D, et al. Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial. Trials 2010;11:118.
4. Khairum NB, Nor Aripin, Sammons HM, et al. Published Pediatric Randomised Drug Trials in Developing Countries 1996-2002. Pediatric Drugs 2010;12:99-103.
5. Hartling L, Wittmeier KD, Caldwell PH, et al. StaR Child Health: developing evidence-based guidance for the design, conduct, and reporting of pediatric trials. Clin Pharmacol Ther 2011;90:727-31.
6. Better Medicines for Children WHO. Sixth World Health Assembly Agenda item 12.18. Eleventh Plenary, 23 May 2007. WHA 60/VR/11. www.who.int/entity/ childmedicines/publications/WHA6020.pdf (accessed February 2012)
7. Barnes KI, Mwenechanya J, Tembo M, et al. Efficacy of rectal artesunate compared with parenteral quinine in initial treatment of moderately severe malaria in African children and adults: a randomised study. Lancet 2004;363:1598-605. (Pubitemid 38625662)
8. Gomes MF, Faiz MA, Gyapong JO, et al. Pre-referral rectal artesunate to prevent death and disability in severe malaria: a placebo-controlled trial. Lancet 2009; 373:557-66.
9. Madhi SA, Cunliffe NA, Steele D, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med 2010;362:289-98.
10. Boga M, Davies A, Kamuya D, et al. Strengthening the informed consent process in international health research through community engagement: The KEMRI-Wellcome Trust Research Programme Experience. PLoS Med 2011;8:e1001089.
11. Gikonyo C, Bejon P, Marsh V, et al. Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast. Soc Sci Med 2008; 67:708-20. (Pubitemid 352004086)
12. Maitland K, Kiguli S, Opoka RO, et al. Mortality after fluid bolus in African children with severe infection. N Engl J Med 2011;364:2483-95.
13. Agnandji ST, Lell B, Soulanoudjingar SS, et al. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children. N Engl J Med 2011; 365:1863-75.
14. Brownsword R, Cermak A, Chaisson R, et al. The Ancillary-Care Obligations of Medical Researchers Working in Developing Countries. PLoS Medicine 2008;5:e90.