Journal article
Recruitment & retention program for the NeuroNEXT SMA Biomarker Study: Super Babies for SMA
Contemporary clinical trials communications, Vol.11, pp.113-119
09/2018
DOI: 10.1016/j.conctc.2018.07.002
PMCID: PMC6072892
PMID: 30094386
Abstract
Recruitment and retention of research participants are challenging and critical components of successful clinical trials and natural history studies. Infants with spinal muscular atrophy (SMA) have been a particularly challenging population to study due to their fragile and complex medical issues, poor prognosis and, until 2016, a lack of effective therapies. Recruitment of healthy infants into clinical trials and natural history studies is also challenging and sometimes assumed to not be feasible.
In 2011, our group initiated a two-year, longitudinal natural history study of infants with SMA and healthy infant controls to provide data to assist in the analysis and interpretation of planned clinical trials in infants with SMA. The recruitment goal was to enroll 27 infants less than 6 months of age with SMA and 27 age-matched healthy infants within the two-year enrollment period. A detailed recruitment and retention plan was developed for this purpose. In addition, a survey was administered to participant families to understand the determinants of participation in the study.
All healthy infants were recruited within the study's first year and 26 SMA infants were recruited within the two-year recruitment period. Thirty-eight participant families responded to the recruitment determinants survey. Nearly half of respondents (18/38, 48%) reported that they first heard of the study from their physician or neurologist. The most common reason to decide to enroll their infant (22/38, 58%) and to remain in the study (28/38, 74%) was their understanding of the importance of the study. Thematic recruitment tools such as a study brochure, video on social media, and presentations at advocacy meetings were reported to positively influence the decision to enroll.
A proactive, thematic and inclusive recruitment and retention plan that effectively communicates the rationale of a clinical study and partners with patients, advocacy groups and the local communities can effectively recruit participants in vulnerable populations. Recommendations for the proactive integration of recruitment and retention plans into clinical trial protocol development are provided.
Details
- Title: Subtitle
- Recruitment & retention program for the NeuroNEXT SMA Biomarker Study: Super Babies for SMA
- Creators
- Amy Bartlett - Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, United StatesStephen J Kolb - Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, United StatesAllison Kingsley - Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, United StatesKathryn J Swoboda - Department of Neurology, University of Utah, Salt Lake City, UT, United StatesSandra P Reyna - Department of Neurology, University of Utah, Salt Lake City, UT, United StatesAi Sakonju - Department of Neurology, University of Utah, Salt Lake City, UT, United StatesNancy Kuntz - Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, United StatesDiana Castro - UT Southwestern Medical Center, Dallas, TX, United StatesSusan T Iannaccone - UT Southwestern Medical Center, Dallas, TX, United StatesJulie Parsons - Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO, United StatesAnne M Connolly - Washington University School of Medicine in St. Louis, St. Louis, MO, United StatesClaudia A Chiriboga - Department of Neurology, Columbia College of Physicians and Surgeons, New York, NY, United StatesCraig McDonald - University of California - Davis, Davis, CA, United StatesW. Bryan Burnette - Vanderbilt University, Nashville, TN, United StatesKlaus Werner - Duke University Medical Center, Durham, NC, United StatesMathula Thangarajh - Children's National Medical Center, Washington, DC, United StatesPerry B Shieh - University of California - Los Angeles, Los Angeles, CA, United StatesErika Finanger - Dorenbecher Children's Hospital, Portland, OR, United StatesChristopher S Coffey - Department of Biostatistics, NeuroNEXT Data Coordinating Center, University of Iowa, Iowa City, IA, United StatesJon W Yankey - Department of Biostatistics, NeuroNEXT Data Coordinating Center, University of Iowa, Iowa City, IA, United StatesMerit E Cudkowicz - Department of Neurology, NeuroNEXT Clinical Coordinating Center, Massachusetts General Hospital, Boston, MA, United StatesMichelle M McGovern - Department of Neurology, NeuroNEXT Clinical Coordinating Center, Massachusetts General Hospital, Boston, MA, United StatesD. Elizabeth McNeil - Biogen, Boston, MA, United StatesW. David Arnold - Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, United StatesJohn T Kissel - Department of Neurology, The Ohio State University Wexner Medical Center, Columbus, OH, United StatesNeuroNEXT Clinical Trial NetworkNN101 SMA Biomarker Investigators
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials communications, Vol.11, pp.113-119
- DOI
- 10.1016/j.conctc.2018.07.002
- PMID
- 30094386
- PMCID
- PMC6072892
- NLM abbreviation
- Contemp Clin Trials Commun
- ISSN
- 2451-8654
- eISSN
- 2451-8654
- Publisher
- Elsevier Inc
- Grant note
- DOI: 10.13039/100000065, name: NINDS, award: U01NS079163; DOI: 10.13039/100007721, name: Cure SMA; DOI: 10.13039/100005202, name: Muscular Dystrophy Association; DOI: 10.13039/100000894, name: SMA Foundation; DOI: 10.13039/100000065, name: NINDS, award: U01NS077179, U01NS077352
- Language
- English
- Date published
- 09/2018
- Academic Unit
- Biostatistics
- Record Identifier
- 9984214668302771
Metrics
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