Clinical trials: Kids are not just little people

Clinics in Dermatology - Tập 35 - Trang 583-593 - 2017
Fludiona Naka1, Bruce Strober2, Mona Shahriari2
1University of Connecticut School of Medicine, Farmington, CT
2Department of Dermatology, University of Connecticut Health Center, Farmington, CT

Tài liệu tham khảo

National Institutes of Health Johnson, 2004, Defining the burden of skin disease in the United States—a historical perspective, J Invest Dermatol Symp Proc, 9, 108, 10.1046/j.1087-0024.2003.09117.x Hay, 2014, The global burden of skin disease in 2010: An analysis of the prevalence and impact of skin conditions, J Invest Dermatol, 134, 1527, 10.1038/jid.2013.446 Kearns, 2003, Developmental pharmacology: Drug disposition, action, and therapy in infants and children, N Engl J Med, 349, 1157, 10.1056/NEJMra035092 Novak, 2007, Prescribing medications in pediatrics: Concerns regarding FDA approval and pharmacokinetics, Pediatr Nurs, 33, 64 Field, 2004 Wittich, 2012, Ten common questions (and their answers) about off-label drug use, Mayo Clin Proc, 87, 982, 10.1016/j.mayocp.2012.04.017 Shah, 2007, Off-label drug use in hospitalized children, Arch Pediatr Adolesc Med, 161, 282, 10.1001/archpedi.161.3.282 Pandolfini, 2004, The off-label use of drugs in children is a common aspect of prescribing throughout the world, G Ital Farm Clin, 18, 364 Choonara, 2002, Unlicensed and off-label drug use in children: Implications for safety, Drug Saf, 25, 1, 10.2165/00002018-200225010-00001 Cuzzolin, 2006, Off-label and unlicensed prescribing for newborns and children in different settings: A review of the literature and a consideration about drug safety, Expert Opin Drug Saf, 5, 703, 10.1517/14740338.5.5.703 Lindell-Osuagwu, 2009, Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature, J Clin Pharm Ther, 34, 277, 10.1111/j.1365-2710.2008.01005.x Czarniak, 2015, Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital, PLoS One, 10, 10.1371/journal.pone.0120630 Bourgeois, 2012, Pediatric versus adult drug trials for conditions with high pediatric disease burden, Pediatrics, 130, 285, 10.1542/peds.2012-0139 Karimkhani, 2014, Global burden of skin disease as reflected in Cochrane Database of Systematic Reviews, JAMA Dermatol, 150, 945, 10.1001/jamadermatol.2014.709 Bourgeois, 2014, Association between pediatric clinical trials and global burden of disease, Pediatrics, 133, 78, 10.1542/peds.2013-2567 Klassen, 2008, Children are not just small adults: The urgent need for high-quality trial evidence in children, PLoS Med, 5, 1180, 10.1371/journal.pmed.0050172 Cohen, 2010, Child versus adult randomized controlled trials in specialist journals: A citation analysis of trends, 1985-2005, Arch Pediatr Adolesc Med, 164, 283, 10.1001/archpediatrics.2009.291 Cohen, 2007, An absence of pediatric randomized controlled trials in general medical journals, 1985-2004, J Clin Epidemiol, 60, 118, 10.1016/j.jclinepi.2006.03.015 Wilson, 1999, An update on the therapeutic orphan, Pediatrics, 104, 585, 10.1542/peds.104.S3.585 Ren, 2015, Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?, Semin Perinatol, 39, 530, 10.1053/j.semperi.2015.08.006 Schreiner, 2003, Paediatric clinical trials: Redressing the imbalance, Nat Rev Drug Discov, 2, 949, 10.1038/nrd1253 Sugarman, 2010, Impediments to research in pediatric dermatology: The results of a survey of the members of the society for pediatric dermatology, Pediatr Dermatol, 27, 337, 10.1111/j.1525-1470.2010.01162.x Katz, 2006, FDA update, Epilepsy Res, 68, 85, 10.1016/j.eplepsyres.2005.09.034 Nelson, 2013 Sedgwick, 2014, What are the four phases of clinical research trials?, BMJ (Online), 348 Ellimoottil, 2015, A primer on clinical trial design, Urol Oncol Semin Orig Invest, 33, 116 Salazar, 2003, Pediatric clinical trial experience: Government, child, parent and physician’s perspective, Pediatr Infect Dis J, 22, 1124, 10.1097/01.inf.0000101847.22501.e7 Bavdekar, 2013, Pediatric clinical trials, Perspect Clin Res, 4, 89, 10.4103/2229-3485.106403 U.S. Food and Drug Administration Shaddy, 2010, Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations, Pediatrics, 125, 850, 10.1542/peds.2010-0082 Shah, 2004, How do Institutional Review Boards apply the federal risk and benefit standards for pediatric research, JAMA, 291, 476, 10.1001/jama.291.4.476 Bagatin, 2013, How to design and write a clinical research protocol in cosmetic dermatology, An Bras Dermatol, 88, 69, 10.1590/S0365-05962013000100008 Alosh, 2009, Clinical trials and statistical analyses: What should dermatologists look for in a report?, Dermatol Ther, 22, 199, 10.1111/j.1529-8019.2009.01232.x Pincus, 2004, Clinical trials in rheumatic diseases: Designs and limitations, Rheum Dis Clin North Am, 30, 701, 10.1016/j.rdc.2004.08.002 Martinez-Castaldi, 2008, Child versus adult research: The gap in high-quality study design, Pediatrics, 122, 52, 10.1542/peds.2007-2849 Caldwell, 2004, Clinical trials in children, Lancet, 364, 803, 10.1016/S0140-6736(04)16942-0 Thompson, 2012 Miller, 2003, When do the federal regulations allow placebo-controlled trials in children?, J Pediatr, 142, 102, 10.1067/mpd.2003.43 UCLA Office of Human Research Protection Program Gardner, 2016, A protocol for a systematic review of non-randomised evaluations of strategies to improve participant recruitment to randomised controlled trials, Syst Rev, 5, 10.1186/s13643-016-0308-3 Foster, 2015, Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: Lessons for future trials, BMC Med Res Methodol, 15, 10.1186/s12874-015-0012-3 Friedman, 2015, A qualitative study of recruitment barriers, motivators, and community-based strategies for increasing clinical trials participation among rural and urban populations, Am J Health Promot, 29, 332, 10.4278/ajhp.130514-QUAL-247 Ross, 1999, Barriers to participation in randomised controlled trials: A systematic review, J Clin Epidemiol, 52, 1143, 10.1016/S0895-4356(99)00141-9 Meaux, 2001, Balancing recruitment and protection: Children as research subjects, Issues Compr Pediatr Nurs, 24, 241, 10.1080/014608601753260335 Mody, 2008, Recruitment and retention of older adults in aging research, J Am Geriatr Soc, 56, 2340, 10.1111/j.1532-5415.2008.02015.x Caldwell, 2003, Parents’ attitudes to children’s participation in randomized controlled trials, J Pediatr, 142, 554, 10.1067/mpd.2003.192 Luchtenberg, 2015, Young people’s experiences of participation in clinical trials: Reasons for taking part, Am J Bioeth, 15, 3, 10.1080/15265161.2015.1088974 Caldwell, 2002, Pediatricians’ attitudes toward randomized controlled trials involving children, J Pediatr, 141, 798, 10.1067/mpd.2002.129173 Paine, 2008, Seminars may increase recruitment to randomised controlled trials: Lessons learned from WISDOM, Trials, 9, 10.1186/1745-6215-9-5 Grady, 2005, Payment of clinical research subjects, J Clin Invest, 115, 1681, 10.1172/JCI25694 Grady, 2005, An analysis of U.S. practices of paying research participants, Contemp Clin Trials, 26, 365, 10.1016/j.cct.2005.02.003 Weise, 2002, National practices regarding payment to research subjects for participating in pediatric research, Pediatrics, 110, 577, 10.1542/peds.110.3.577 Johnson, 2015, Recruiting children for clinical trials: Lessons from pediatric oncology, Am J Bioeth, 15, 24, 10.1080/15265161.2015.1088980 Knox, 2007, Issues related to children participating in clinical research, J Pediatr Nurs, 22, 310, 10.1016/j.pedn.2007.02.004 Hoppu, 1999, Patient recruitment: European perspective, Pediatrics, 104, 623, 10.1542/peds.104.S3.623 Treweek, 2010, Strategies to improve recruitment to randomised controlled trials, Cochrane Database Syst Rev, MR000013 Treweek, 2013, Methods to improve recruitment to randomised controlled trials: Cochrane Systematic Review and Meta-Analysis, BMJ Open, 3, 10.1136/bmjopen-2012-002360 Caldwell, 2010, Strategies for increasing recruitment to randomised controlled trials: Systematic review, PLoS Med, 7, 10.1371/journal.pmed.1000368 Crawley, 2001, African-American participation in clinical trials: Situating trust and trustworthiness, J Natl Med Assoc, 93 Frank, 2003, Retaining school children and families in community research: Lessons from the Study of Children’s Activity and Nutrition (SCAN), J Sch Health, 73, 51, 10.1111/j.1746-1561.2003.tb03571.x Roy, 2013, Recruitment and retention strategies in a clinical trial for children with chronic hepatitis c infection, J Pediatr Nurs, 28, 243, 10.1016/j.pedn.2012.08.006 Jones, 2005, Informed consent: It’s not just signing a form, Thorac Surg Clin, 15, 451, 10.1016/j.thorsurg.2005.06.001 Shekelle, 2013, Making health care safer II: An updated critical analysis of the evidence for patient safety practices, Evid Rep Technol Assess (Full Rep), 1 Kon, 2006, Assent in pediatric research, Pediatrics, 117, 1806, 10.1542/peds.2005-2926 Cachat, 2011 Steinbrook, 2002, Testing medications in children, New Engl J Med, 347, 1462, 10.1056/NEJMhpr021646 Totri CR, Eichenfield LF. Clinical research in pediatric dermatology. In: Nasir A, ed. Clinical Dermatology Trials 101: A Primer for Dermatologists. New York, NY: Springer: 161-176. Bruckner, 2012, A perspective on clinical and translational research in pediatric dermatology, J Invest Dermatol, 132, 497, 10.1038/jid.2011.419 U.S. Department of Health and Human Services