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. 2018 Jul 20:11:113-119.
doi: 10.1016/j.conctc.2018.07.002. eCollection 2018 Sep.

Recruitment & retention program for the NeuroNEXT SMA Biomarker Study: Super Babies for SMA!

Amy Bartlett  1 , Stephen J Kolb  1   2 , Allison Kingsley  1 , Kathryn J Swoboda  3   4   5 , Sandra P Reyna  3   4   6 , Ai Sakonju  3   4   7 , Basil T Darras  5 , Richard Shell  8 , Nancy Kuntz  9 , Diana Castro  10 , Susan T Iannaccone  10 , Julie Parsons  11 , Anne M Connolly  12 , Claudia A Chiriboga  13 , Craig McDonald  14 , W Bryan Burnette  15 , Klaus Werner  16 , Mathula Thangarajh  17 , Perry B Shieh  18 , Erika Finanger  19 , Christopher S Coffey  20 , Jon W Yankey  20 , Merit E Cudkowicz  21 , Michelle M McGovern  21 , D Elizabeth McNeil  22   6 , W David Arnold  1   23 , John T Kissel  1 ; NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators
Affiliations

Recruitment & retention program for the NeuroNEXT SMA Biomarker Study: Super Babies for SMA!

Amy Bartlett et al. Contemp Clin Trials Commun. .

Erratum in

Abstract

Background/aims: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Altruism; Healthy controls; Network; Social media; Spinal muscle atrophy.

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Figures

Fig. 1
Fig. 1
Cumulative enrollment of the NeuroNEXT SMA Infant Biomarker Study Enrollment of 27 healthy control infants (blue line) and 26 infants with SMA (red line) exceeded expected 2-year enrollment estimate (dotted black line). (For interpretation of the references to color in this figure legend, the reader is referred to the Web version of this article.)
Fig. 2
Fig. 2
Super Baby! Thematic Materials A. Artwork donated for the project was incorporated into all communications with participant families. B. Super Baby! thank-you notes with thematic fonts and colors sent after each study visit. C. Super Baby! diplomas with thematic fonts and colors presented to each participant family with actual Super Baby! onsie with cape. (For interpretation of the references to color in this figure legend, the reader is referred to the Web version of this article.)
Fig. 3
Fig. 3
Super Baby! onesie. NeuroNEXT Biomarker Study infants wearing branded “I'm Super” onesie.
See this image and copyright information in PMC

References

    1. Bedlack R.S., Cudkowicz M.E. Clinical trials in progressive neurological diseases. Recruitment, enrollment, retention and compliance. Front. Neurol. Neurosci. 2009;25:144–151. - PubMed
    1. Carlisle B., Kimmelman J., Ramsay T., MacKinnon N. Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials. Clin. Trials. 2015;12(1):77–83. - PMC - PubMed
    1. Comis R.L., Miller J.D., Aldige C.R., Krebs L., Stoval E. Public attitudes toward participation in cancer clinical trials. J. Clin. Oncol. 2003;21(5):830–835. - PubMed
    1. Sullivan-Bolyai S., Bova C., Deatrick J.A., Knafl K., Grey M., Leung K. Barriers and strategies for recruiting study participants in clinical settings. West. J. Nurs. Res. 2007;29(4):486–500. - PubMed
    1. Segre L.S., Buckwalter K.C., Friedemann M.L. Strategies to engage clinical staff in subject recruitment. J. Res. Nurs. 2011;16(4):321–332. - PMC - PubMed