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

The NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)113-119
Number of pages7
JournalContemporary Clinical Trials Communications
Volume11
DOIs
StatePublished - Sep 1 2018
Externally publishedYes

Fingerprint

Spinal Muscular Atrophy
Biomarkers
Natural History
Clinical Trials
Clinical Protocols
Social Media
Patient Advocacy
Pamphlets
Vulnerable Populations
Physicians

Keywords

  • Altruism
  • Healthy controls
  • Network
  • Social media
  • Spinal muscle atrophy

ASJC Scopus subject areas

  • Pharmacology

Cite this

Recruitment & retention program for the NeuroNEXT SMA Biomarker Study : Super Babies for SMA! / The NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators.

In: Contemporary Clinical Trials Communications, Vol. 11, 01.09.2018, p. 113-119.

Research output: Contribution to journalArticle

The NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators 2018, 'Recruitment & retention program for the NeuroNEXT SMA Biomarker Study: Super Babies for SMA!', Contemporary Clinical Trials Communications, vol. 11, pp. 113-119. https://doi.org/10.1016/j.conctc.2018.07.002
The NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators. / Recruitment & retention program for the NeuroNEXT SMA Biomarker Study : Super Babies for SMA!. In: Contemporary Clinical Trials Communications. 2018 ; Vol. 11. pp. 113-119.
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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.",
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T1 - Recruitment & retention program for the NeuroNEXT SMA Biomarker Study

T2 - Super Babies for SMA!

AU - The NeuroNEXT Clinical Trial Network and on behalf of the NN101 SMA Biomarker Investigators

AU - Bartlett, Amy

AU - Kolb, Stephen J.

AU - Kingsley, Allison

AU - Swoboda, Kathryn J.

AU - Reyna, Sandra P.

AU - Sakonju, Ai

AU - Darras, Basil T.

AU - Shell, Richard

AU - Kuntz, Nancy

AU - Castro, Diana

AU - Iannaccone, Susan T.

AU - Parsons, Julie

AU - Connolly, Anne M.

AU - Chiriboga, Claudia A.

AU - McDonald, Craig

AU - Burnette, W. Bryan

AU - Werner, Klaus

AU - Thangarajh, Mathula

AU - Shieh, Perry B.

AU - Finanger, Erika

AU - Coffey, Christopher S.

AU - Yankey, Jon W.

AU - Cudkowicz, Merit E.

AU - McGovern, Michelle M.

AU - McNeil, D. Elizabeth

AU - Arnold, W. David

AU - Kissel, John T.

PY - 2018/9/1

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N2 - 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.

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KW - Altruism

KW - Healthy controls

KW - Network

KW - Social media

KW - Spinal muscle atrophy

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