Pediatric drug-trial recruitment: Enticement without coercion

Pediatrics

Volumn 127, Issue 5, 2011, Pages 949-954

  Tishler, Carl L ^a   Reiss, Natalie Staats ^b  

^a OHIO STATE UNIVERSITY   (United States)

^b CASE WESTERN RESERVE UNIVERSITY   (United States)

Author keywords

Clinical drug trials; Pediatrics; Research; Subject recruitment

Indexed keywords

CHILD; CLINICAL TRIAL (TOPIC); DATA BASE; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; FEE; FUNDING; HUMAN; PRIORITY JOURNAL; RESEARCH SUBJECT; REVIEW;

ADOLESCENT; AGE FACTORS; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; COERCION; DRUGS, INVESTIGATIONAL; FEMALE; HUMANS; MALE; NEEDS ASSESSMENT; PATIENT SELECTION; PEDIATRICS; RESEARCH DESIGN; RISK ASSESSMENT; UNITED STATES;

EID: 79955485556     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2010-2585     Document Type: Review

References (39)

1. Knox CA, Burkhart PV. Issues related to children participating in clinical research. J Pediatr Nurs. 2007;22(4):310-318
2. Caldwell PHY, Murphy SB, Butow PN, Craig JC. Clinical trials in children. Lancet. 2004; 364(9436):803-811 (Pubitemid 39165102)
3. Macrae D. Conducting clinical trials in pediatrics. Crit Care Med. 2009;37(1 suppl): S136-S139
4. Parens E, Johnston J, Carlson GA. Pediatric mental health care dysfunction disorder? N Engl J Med. 2010;362(20):1853-1855
5. Hay WW, Gitterman DP, Williams DA, Dover GJ, Sectish TC, Schleiss MR. Child health research funding and policy: imperatives and investments for a healthier world. Pediatrics. 2010;125(6):1259-1265
6. Gill D, Kurz R. Practical and ethical issues in pediatric clinical trials. Appl Clin Trials. 2002:60-63
7. Lantos JD. Pediatric research: what is broken and what needs to be fixed? J Pediatr. 2004;144(2):147-149 (Pubitemid 38869386)
8. Mathis L. Growth and development of pediatric drug development at the FDA. Presented at: Institute of Medicine Workshop on Addressing the Barriers to Pediatric Drug Development; June 13, 2006; Washington, DC. Available at: www.nap.edu/ openbook.php?record-id=11911&page= R1. Accessed January 10, 2010
9. Murphy D. Current challenges in developing and prescribing drugs for children. Presented at: Institute of Medicine Workshop on Addressing the Barriers to Pediatric Drug Development; June 13, 2006; Washing- ton, DC. Available at: www.nap.edu/ openbook.php?record-id=11911&page= 20. Accessed January 10, 2010
10. Shah SS, Hall M, Goodman DM, et al. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med. 2007;161(3):282-290 (Pubitemid 46364332)
11. Waisel DB. Moral responsibility to attain thorough pediatric drug labeling. Paediatr Anaesth. 2009;19(10):989-993
12. Cohen E, Goldman RD, Ragone A, et al. Child vs adult randomized controlled trials in specialist journals: a citation analysis of trends, 1985-2005. Arch Pediatr Adolesc Med. 2010;164(3):283-288
13. Burns JP. Research in children. Crit Care Med. 2003;31(3 suppl):S131-S136 (Pubitemid 36379557)
14. Ernest TB, Elder DP, Martini LG, Roberts M, Ford JL. Developing paediatric medicines: identifying the needs and recognizing the challenges. J Pharm Pharmacol. 2007; 59(8):1043-1055 (Pubitemid 47265351)
15. Pasquali SK, Hall M, Slonim AD, et al. Cardiovascular medications in children hospitalized with congenital and acquired heart disease. Circ Cardiovasc Qual Outcomes. 2008; 1(2):74-83
16. Davidson AJ, O'Brien M. Ethics and medical research in children. Paediatr Anaesth. 2009;19(10):994-1004
17. Holdsworth MT. Pediatric drug research: the road less traveled. Ann Pharmacother. 2003;37(4):586-591 (Pubitemid 36389673)
18. Conroy S, Choonara I, Impicciatore P. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ. 2000;320(7227):79-82 (Pubitemid 30173044)
19. Steinbrook R. Testing medications in children. N Engl J Med. 2002;347(18):1462-1470 (Pubitemid 35239728)
20. Gill D; Ethics Working Group of the Confederation of European Specialists in Paediatrics. Ethical principles and operational guidelines for good clinical practice in paediatric research: recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr. 2004;163(2):53-57
21. Edwards SD, McNamee MJ. Ethical concerns regarding guidelines for the conduct of clinical research on children. J Med Ethics. 2005;31(6):351-354 (Pubitemid 40823804)
22. Turner S, Nunn A, Fielding K, Choonara I. Adverse drug reactions to unlicensed and offlabel drugs on paediatric wards: a prospective study. Acta Paediatr. 1999;88(9): 965-968 (Pubitemid 29448261)
23. Vollmer WM, Hertert S, Allison MJ. Recruiting children and their families for clinical trials: a case study. Control Clin Trials. 1992; 13(4):315-320
24. Jarrett N. Incentives and disincentives for pediatric drug development. Presented at: Institute of Medicine Workshop on Addressing the Barriers to Pediatric Drug Development; June 13, 2006; Washington, DC
25. Center for Health and Pharmaceutical Law and Policy. Conflicts of interest in clinical trial recruitment and enrollment: a call for increased oversight. Available at: http://law.shu. edu/ProgramsCenters/HealthTechIP/ upload/ health-center-whitepaper-nov2009.pdf. Accessed January 12, 2010
26. Wendler D, Rackoff JE, Emanuel EJ, Grady C. The ethics of paying for children's participation in research. J Pediatr. 2002;141(2): 166-171
27. Weise KL, Smith ML, Maschke KJ, Copeland HL. National practices regarding payment to research subjects for participating in pediatric research. Pediatrics. 2002;110(3): 577-582 (Pubitemid 34976689)
28. Rice M, Broome ME. Incentives for children in research. J Nurs Scholarsh. 2004;36(2): 167-172 (Pubitemid 41794728)
29. Kimberly MB, Hoehn KS, Feudtner C, Nelson RM, Schreiner M. Variations in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permissions and assent forms for 3 multicenter pediatric clinical trials. Pediatrics. 2006; 117(5):1706-1711 (Pubitemid 46071401)
30. Iltis AS. Vulnerability in biomedical research. J Law Med Ethics. 2009;37(1):6-11
31. Frank G, Nader P, Zive M, Broyles S, Brennan J. Retaining school children and families in community research: lessons from the Study of Children's Activity and Nutrition (SCAN). J Sch Health. 2003;73(2):51-57 (Pubitemid 38885708)
32. Jefferey A, Perkins J. How do you ensure that children stay with a longitudinal study? Nurs Stand. 2002;16(32):22
33. Shah S, Whittle A, Wilfond B, Gensler G, Wendler D. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA. 2004;291(4): 476-482 (Pubitemid 38129752)
34. Tishler CL, Bartholomae S. The recruitment of normal healthy volunteers: a review of the literature on the use of incentives. J Clin Pharmacol. 2002;42(4):365-375 (Pubitemid 34259769)
35. Wendler D, Belsky L, Thompson KM, Emanuel EJ. Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit. JAMA. 2005;294(7):826-832 (Pubitemid 41178967)
36. Dickert N, Grady C. What's the price of a research subject? Approaches to payment for research participation. N Engl J Med. 1999; 341(3):198-203 (Pubitemid 29325751)
37. Tishler CL, Gordon LB. Ethical parameters of challenge studies inducing psychosis with ketamine. Ethics Behav. 1999;9(3):211-217
38. Spetie L, Arnold LE. Ethical issues in child psychopharmacology research and practice: emphasis on preschoolers. Psychopharmacology (Berl). 2007;191(1): 15-26 (Pubitemid 46294952)
39. Mukattash TL, Millership JS, Collier PS, McElnay JC. Public awareness and views on unlicensed use of medications in children. Br J Clin Pharmacol. 2008;66(6):838-845