Abstract
Background: Randomized clinical trials often encounter slow enrollment. Failing to meet sample size requirements has scientific, financial, and ethical implications. Aims: We report interventions used to accelerate recruitment in a large multicenter clinical trial that was not meeting prespecified enrollment commitments. Methods: The Carotid Revascularization Endarterectomy vs. Stenting Trial began randomization in December 2000. To accelerate enrollment, multiple recruitment tactics were initiated, which included expanding the number of sites, hiring a recruitment director (May 2003), broadening eligibility criteria (April 2005), branding with a study logo, Web site, and recruitment materials, increasing site visits by study leadership, sending e-mails to the site teams after every enrollment, distributing electronic newsletters, and implementing investigator and coordinator conferences. Results: From December 2000 through May 2003, 14 sites became active (54 patients randomized), from June 2003 through April 2005, 44 sites were added (404 patients randomized), and from May 2005 through July 2008, 54 sites were added (2044 patients randomized). During these time intervals, the number of patients enrolled per site per year was 1·5, 3·6, and 5·6. For the single years 2004 to 2008, the mean monthly randomization rates per year were 19·7, 38·1, 56·4, 53·0, and 54·7 (annualized), respectively. Enrollment was highest after recruitment tactics were implemented: 677 patients in 2006, 636 in 2007, and 657 in 2008 (annualized). The prespecified sample size of 2502 patients, 47% asymptomatic, was accomplished on July 2008. Conclusions: Aggressive recruitment tactics and investment in a full-time recruitment director who can lead implementation may be effective in accelerating recruitment in multicenter trials.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 447-453 |
| Number of pages | 7 |
| Journal | International Journal of Stroke |
| Volume | 7 |
| Issue number | 6 |
| DOIs | |
| State | Published - Aug 2012 |
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Keywords
- Carotid endarterectomy
- Carotid stenosis
- Carotid stenting
- Clinical trial
- Prevention
- Stroke
ASJC Scopus subject areas
- Neurology
Cite this
Interventions to increase enrollment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy. / Longbottom, Mary E.; Roberts, Jamie N.; Tom, Meelee; Hughes, Susan E.; Howard, Virginia J.; Sheffet, Alice J.; Meschia, James F; Brott, Thomas G.
In: International Journal of Stroke, Vol. 7, No. 6, 08.2012, p. 447-453.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Interventions to increase enrollment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy
AU - Longbottom, Mary E.
AU - Roberts, Jamie N.
AU - Tom, Meelee
AU - Hughes, Susan E.
AU - Howard, Virginia J.
AU - Sheffet, Alice J.
AU - Meschia, James F
AU - Brott, Thomas G
PY - 2012/8
Y1 - 2012/8
N2 - Background: Randomized clinical trials often encounter slow enrollment. Failing to meet sample size requirements has scientific, financial, and ethical implications. Aims: We report interventions used to accelerate recruitment in a large multicenter clinical trial that was not meeting prespecified enrollment commitments. Methods: The Carotid Revascularization Endarterectomy vs. Stenting Trial began randomization in December 2000. To accelerate enrollment, multiple recruitment tactics were initiated, which included expanding the number of sites, hiring a recruitment director (May 2003), broadening eligibility criteria (April 2005), branding with a study logo, Web site, and recruitment materials, increasing site visits by study leadership, sending e-mails to the site teams after every enrollment, distributing electronic newsletters, and implementing investigator and coordinator conferences. Results: From December 2000 through May 2003, 14 sites became active (54 patients randomized), from June 2003 through April 2005, 44 sites were added (404 patients randomized), and from May 2005 through July 2008, 54 sites were added (2044 patients randomized). During these time intervals, the number of patients enrolled per site per year was 1·5, 3·6, and 5·6. For the single years 2004 to 2008, the mean monthly randomization rates per year were 19·7, 38·1, 56·4, 53·0, and 54·7 (annualized), respectively. Enrollment was highest after recruitment tactics were implemented: 677 patients in 2006, 636 in 2007, and 657 in 2008 (annualized). The prespecified sample size of 2502 patients, 47% asymptomatic, was accomplished on July 2008. Conclusions: Aggressive recruitment tactics and investment in a full-time recruitment director who can lead implementation may be effective in accelerating recruitment in multicenter trials.
AB - Background: Randomized clinical trials often encounter slow enrollment. Failing to meet sample size requirements has scientific, financial, and ethical implications. Aims: We report interventions used to accelerate recruitment in a large multicenter clinical trial that was not meeting prespecified enrollment commitments. Methods: The Carotid Revascularization Endarterectomy vs. Stenting Trial began randomization in December 2000. To accelerate enrollment, multiple recruitment tactics were initiated, which included expanding the number of sites, hiring a recruitment director (May 2003), broadening eligibility criteria (April 2005), branding with a study logo, Web site, and recruitment materials, increasing site visits by study leadership, sending e-mails to the site teams after every enrollment, distributing electronic newsletters, and implementing investigator and coordinator conferences. Results: From December 2000 through May 2003, 14 sites became active (54 patients randomized), from June 2003 through April 2005, 44 sites were added (404 patients randomized), and from May 2005 through July 2008, 54 sites were added (2044 patients randomized). During these time intervals, the number of patients enrolled per site per year was 1·5, 3·6, and 5·6. For the single years 2004 to 2008, the mean monthly randomization rates per year were 19·7, 38·1, 56·4, 53·0, and 54·7 (annualized), respectively. Enrollment was highest after recruitment tactics were implemented: 677 patients in 2006, 636 in 2007, and 657 in 2008 (annualized). The prespecified sample size of 2502 patients, 47% asymptomatic, was accomplished on July 2008. Conclusions: Aggressive recruitment tactics and investment in a full-time recruitment director who can lead implementation may be effective in accelerating recruitment in multicenter trials.
KW - Carotid endarterectomy
KW - Carotid stenosis
KW - Carotid stenting
KW - Clinical trial
KW - Prevention
KW - Stroke
UR - http://www.scopus.com/inward/record.url?scp=84863994481&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84863994481&partnerID=8YFLogxK
U2 - 10.1111/j.1747-4949.2012.00833.x
DO - 10.1111/j.1747-4949.2012.00833.x
M3 - Article
VL - 7
SP - 447
EP - 453
JO - International Journal of Stroke
JF - International Journal of Stroke
SN - 1747-4930
IS - 6
ER -