Recruitment of infants with sickle cell anemia to a Phase III trial: Data from the BABY HUG study

Contemporary Clinical Trials

Volumn 31, Issue 6, 2010, Pages 558-563

  Wynn, Lynn ^a   Miller, Scott ^b   Faughnan, Lane ^a   Luo, Zhaoyu ^c   Debenham, Ellen ^d   Adix, Lea ^e   Fish, Billie ^c   Hustace, Tally ^f   Kelly, Tracy ^g   MacDermott, MaryLou ^h   Marasciulo, Joan ⁱ   Martin, Brenda ^j   McDuffie, Jennifer ^k   Murphy, Mary ^l   Rackoff, Betsy ^m   Reed, Caroline ⁿ   Seaman, Phillip ^o   Thomas, Glenda ^p   Wang, Winfred ^a  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b SUNY DOWNSTATE MEDICAL CENTER   (United States)

^c Clinical Trials and Survey Corporation   (United States)

^d Children's Health Care of Atlanta   (United States)

^e CHILDREN S MEDICAL CENTER   (United States)

^f UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^g DUKE UNIVERSITY MEDICAL CENTER   (United States)

^h DREXEL UNIVERSITY   (United States)

ⁱ SINAI HOSPITAL OF BALTIMORE   (United States)

^j CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^k UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^l CHILDREN'S HOSPITAL OF MICHIGAN   (United States)

^m MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

ⁿ HOWARD UNIVERSITY HOSPITAL   (United States)

^o JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^p UNIVERSITY OF MISSISSIPPI MEDICAL CENTER   (United States)

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Author keywords

Hydroxyurea; Infants; Minorities; Recruitment; Sickle cell

Indexed keywords

HEMOGLOBIN; HYDROXYUREA; PLACEBO;

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; ETHNIC GROUP; HUMAN; INFANT; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PARENTAL ATTITUDE; PATIENT ASSESSMENT; PATIENT PARTICIPATION; PATIENT SELECTION; PATIENT TRANSPORT; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SICKLE CELL ANEMIA;

ANEMIA, SICKLE CELL; ANTISICKLING AGENTS; ATTITUDE TO HEALTH; HUMANS; HYDROXYUREA; INFANT; INFANT, NEWBORN; MOTIVATION; NEONATAL SCREENING; PARENTS; PATIENT SELECTION;

EID: 77957948776     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2010.08.007     Document Type: Article

References (17)

1. Gross D. A research agenda for understanding particpation in clinical research. Res Nurs Health 2006, 29:172-175.
2. Campbell M.K., Snowdon C., Francis D., Elbourne D., McDonald A.M., Knight R., et al. Recruitment to randomized trials: stategies for trial enrollment and particpation study. The STEPS study. Health Technol Assess 2007, 11:48.
3. Wang W.C. Sickle cell anemia and other sickling syndromes (Chpt 37). Wintrobe's clinical hematology 2008, 1038-1082. Lippincott Williams and Wilkins, Philadelphia. 12th edition. J.P. Greer, J. Foerster, G.M. Rodgers, F. Paraskevas, B.E. Glader (Eds.).
4. Thompson B.W., Miller S.T., Rogers Z.R., Rees R., Ware R., Waclawiw M., et al. The pediatric hydroxyurea phase III clinical trial (BABY HUG): challenges of study design. Pediatr Blood Cancer 2010, 54:250-255.
5. Thornburg C.D., Rogers Z.R., Jeng M.R., Rana S.R., Iyer R.V., Faughnan L., et al. Adherence to study medication and visits: data from the BABY HUG trial. Pediatr Blood Cancer 2010, 54:260-264.
6. Mills E.J., Seely D., Rachlis B., Griffith L., Wu P., Wilson K., et al. Barriers to participation in clinical trials of cancer: a metaanalysis and systematic review of patient-reported factors. Lancet Oncol 2006, 7:141-148.
7. Lara P.N., Higdon R., Lim N., Kwan K., Tanaka M., Lau D.H.M., et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol 2001, 19(6):1728-1733.
8. Ford J.H., Howerton M.W., Lai G.Y., Gary T.L., Bolen S., Gibbons M.C., et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 2008, 112(2):228-242.
9. Branson R.D., Davis K., Butler K.L. African Americans' participation in clinical research: importance, barriers, and solutions. Am J Surg 2007, 193:32-39.
10. Outlaw F.H., Bourjolly J.N., Barg F.K. A study on recruitment of black Americans into clinical trials through a cultural competence lens. Cancer Nurs 2000, 23(6):444-451.
11. Julion W., Gross D., Barclay-McLaughlin G. Recruiting families of color from the inner city: insights from the recruiters. Nurs Outlook 2000, 48(5):230-237.
12. Tait A.R., Voepel-Lewis T., Malviya S. Participation of children in clinical research. Anesthesiology 2003, 99:818-825.
13. Vaarma S., Jenkins T., Wendler D. How do children and parents make decisions about pediatric clinical research. J Pediatr Hematol Oncol 2008, 30(11):823-828.
14. Rothmier J.D., Lasley M.V., Shapiro G.G. Factors influencing parental consent in pediatric clinical research. Pediatrics 2003, 111:1037-1041.
15. Caldwell P.H.Y., Butow P.N., Craig J.C. Parent's attitudes to children's participation in randomized clinical controlled trials. J Pediatr 2003, 142(5):554-559.
16. Sammons H.M., Atkinson M., Choonara I., Stephenson T. What motivatess British parents to consent for research? A questionnaire study. BMC Pediatr 2007, 7:12.
17. Liem R.I., Cole A.H., Pelligra S.A., Manson M., Thompson A.A. Parental attitudes toward research participation in pediatric sickle cell disease. Pediatr Blood Cancer 2010, 55:129-133.