Literature DB >> 26176343

Surpassing the Target: How a Recruitment Campaign Transformed the Participant Accrual Trajectory in the Epilepsy Phenome/Genome Project.

Kathleen McGovern1, Catharine Freyer Karn2, Kristen Fox2.   

Abstract

Participant recruitment challenges pervade the majority of publicly funded clinical trials. However, little is known about methods for enhancing participant accrual. The Epilepsy Phenome/Genome Project (EPGP), a multicenter study funded by the National Institute of Neurological Disorders and Stroke (NINDS), aimed to enroll a total of 5,250 participants to better understand the genetic causes and phenotypic manifestations of epilepsy. However, similar to other trials, EPGP encountered recruitment challenges, and by the end of its first year, net enrollment was only 48% of the target for that time. To address this, EPGP established a National Participant Recruitment Campaign and began implementing and tracking the enrollment outcomes of a variety of proven and relatively novel recruitment methods. At the conclusion of the project, EPGP had successfully enrolled a total of 5,445 participants, thus surpassing its enrollment target. Data pertaining to EPGP's National Participant Recruitment Campaign was analyzed retrospectively, and the results are reported here, so that other multicenter trials may consider these methods in their recruitment planning and potentially avoid the costly repercussions of participant accrual issues.
© 2015 Wiley Periodicals, Inc.

Entities:  

Keywords:  clinical trials; participant accrual; study design

Mesh:

Substances:

Year:  2015        PMID: 26176343      PMCID: PMC4626330          DOI: 10.1111/cts.12307

Source DB:  PubMed          Journal:  Clin Transl Sci        ISSN: 1752-8054            Impact factor:   4.689


  10 in total

1.  Clinical trials: the challenge of recruitment and retention of participants.

Authors:  Raisa B Gul; Parveen A Ali
Journal:  J Clin Nurs       Date:  2010-01       Impact factor: 3.036

2.  Ethical challenges encountered in genomic research.

Authors:  Patricia A Roche
Journal:  Circ Cardiovasc Genet       Date:  2009-06

3.  Clinical trial recruitment--a complex intervention?

Authors:  Ralph Tramm; Karen Daws; Verena Schadewaldt
Journal:  J Clin Nurs       Date:  2013-04-03       Impact factor: 3.036

4.  Interventions to increase enrollment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy.

Authors:  Mary E Longbottom; Jamie N Roberts; Meelee Tom; Susan E Hughes; Virginia J Howard; Alice J Sheffet; James F Meschia; Thomas G Brott
Journal:  Int J Stroke       Date:  2012-05-28       Impact factor: 5.266

5.  Lessons learned in participant recruitment and retention: the EXCITE trial.

Authors:  Sarah Blanton; David M Morris; Michelle G Prettyman; Karen McCulloch; Susan Redmond; Kathye E Light; Steven L Wolf
Journal:  Phys Ther       Date:  2006-11

6.  The epilepsy phenome/genome project.

Authors:  Bassel Abou-Khalil; Brian Alldredge; Jocelyn Bautista; Sam Berkovic; Judith Bluvstein; Alex Boro; Gregory Cascino; Damian Consalvo; Sabrina Cristofaro; Patricia Crumrine; Orrin Devinsky; Dennis Dlugos; Michael Epstein; Robyn Fahlstrom; Miguel Fiol; Nathan Fountain; Kristen Fox; Jacqueline French; Catharine Freyer Karn; Daniel Friedman; Eric Geller; Tracy Glauser; Simon Glynn; Kevin Haas; Sheryl Haut; Jean Hayward; Sandra Helmers; Sucheta Joshi; Andres Kanner; Heidi Kirsch; Robert Knowlton; Eric Kossoff; Rachel Kuperman; Ruben Kuzniecky; Daniel Lowenstein; Shannon McGuire; Paul Motika; Gerard Nesbitt; Edward Novotny; Ruth Ottman; Juliann Paolicchi; Jack Parent; Kristen Park; Annapurna Poduri; Neil Risch; Lynette Sadleir; Ingrid Scheffer; Renee Shellhaas; Elliott Sherr; Jerry J Shih; Shlomo Shinnar; Rani Singh; Joseph Sirven; Michael Smith; Joe Sullivan; Liu Lin Thio; Anu Venkat; Eileen Vining; Gretchen von Allmen; Judith Weisenberg; Peter Widdess-Walsh; Melodie Winawer
Journal:  Clin Trials       Date:  2013-07-01       Impact factor: 2.486

7.  Boosting enrollment in neurology trials with Local Identification and Outreach Networks (LIONs).

Authors:  W N Kernan; C M Viscoli; D Demarco; B Mendes; K Shrauger; J L Schindler; J C McVeety; A Sicklick; D Moalli; P Greco; D M Bravata; S Eisen; L Resor; K Sena; D Story; L M Brass; K L Furie; L Gutmann; E Hinnau; M Gorman; A M Lovejoy; S E Inzucchi; L H Young; R I Horwitz
Journal:  Neurology       Date:  2009-04-14       Impact factor: 9.910

8.  The myth of the normal, average human brain--the ICBM experience: (1) subject screening and eligibility.

Authors:  John C Mazziotta; Roger Woods; Marco Iacoboni; Nancy Sicotte; Kami Yaden; Mary Tran; Courtney Bean; Jonas Kaplan; Arthur W Toga
Journal:  Neuroimage       Date:  2008-08-15       Impact factor: 6.556

9.  The Epilepsy Phenome/Genome Project (EPGP) informatics platform.

Authors:  Gerry Nesbitt; Kevin McKenna; Vickie Mays; Alan Carpenter; Kevin Miller; Michael Williams
Journal:  Int J Med Inform       Date:  2012-05-10       Impact factor: 4.046

Review 10.  A systematic review of models to predict recruitment to multicentre clinical trials.

Authors:  Katharine D Barnard; Louise Dent; Andrew Cook
Journal:  BMC Med Res Methodol       Date:  2010-07-06       Impact factor: 4.615

  10 in total
  3 in total

1.  Return of individual results in epilepsy genomic research: A view from the field.

Authors:  Ruth Ottman; Catharine Freyer; Heather C Mefford; Annapurna Poduri; Daniel H Lowenstein
Journal:  Epilepsia       Date:  2018-08-10       Impact factor: 5.864

2.  Familial aggregation of status epilepticus in generalized and focal epilepsies.

Authors:  Judith L Z Weisenberg; Robert T Fitzgerald; John N Constantino; Melodie R Winawer; Liu Lin Thio
Journal:  Neurology       Date:  2020-09-11       Impact factor: 9.910

3.  Outreach to new mothers through direct mail and email: recruitment in the Early Check research study.

Authors:  Ryan S Paquin; Megan A Lewis; Blake A Harper; Rebecca R Moultrie; Angela Gwaltney; Lisa M Gehtland; Holly L Peay; Martin Duparc; Melissa Raspa; Anne C Wheeler; Cynthia M Powell; Nancy M P King; Scott M Shone; Donald B Bailey
Journal:  Clin Transl Sci       Date:  2021-02-13       Impact factor: 4.689

  3 in total

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