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Reporting the Recruitment Process in Clinical Trials: Who Are These Patients and How Did They Get There?

Cary P. Gross, MD; Raburn Mallory, MD; Asefeh Heiat, MD; and Harlan M. Krumholz, MD
[+] Article and Author Information

From Yale University School of Medicine and Yale–New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut; and Louis Stokes–Cleveland Department of Veterans Affairs Medical Center, Youngstown, Ohio.


Acknowledgment: The authors thank Dr. Anna Reisman for her thoughtful comments.

Grant Support: Dr. Gross is supported in part by a Cancer Prevention, Control and Population Sciences Career Development Award (1K07CA-90402).

Requests for Single Reprints: Cary P. Gross, MD, Yale University School of Medicine, Primary Care Center, PO Box 208025, 333 Cedar Street, New Haven, CT 06520; e-mail, cary.gross@yale.edu.

Current Author Addresses: Dr. Gross: Yale University School of Medicine, Primary Care Center, PO Box 208025, 333 Cedar Street, New Haven, CT 06520.

Dr. Mallory: Yale University School of Medicine, Department of Medicine, PO Box 208025, 333 Cedar Street, New Haven, CT 06520.

Dr. Heiat: Louis Stokes–Cleveland Department of Veteran's Affairs Medical Center, Youngstown Outpatient Clinic, 2031 Belmont Avenue, Youngstown, OH 44505.

Dr. Krumholz: Yale University School of Medicine, PO Box 208025, 333 Cedar Street, New Haven, CT 06520.

Author Contributions: Conception and design: C.P. Gross, R. Mallory, A. Heiat, H. Krumholz.

Analysis and interpretation of the data: C.P. Gross. Drafting of the article: C.P. Gross, A. Heiat, H. Krumholz.

Critical revision of the article for important intellectual content: C.P. Gross, R. Mallory, A. Heiat, H. Krumholz.

Final approval of the article: C.P. Gross, R. Mallory, A. Heiat, H. Krumholz.

Administrative, technical, or logistic support: C.P. Gross.

Collection and assembly of data: C.P. Gross, R. Mallory, A. Heiat.


Ann Intern Med. 2002;137(1):10-16. doi:10.7326/0003-4819-137-1-200207020-00007
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We identified 215 RCTs. A total of 43 were excluded for the following reasons: They were subgroup analyses or follow-up studies of previously reported RCTs (n = 24), the unit of randomization was not individual persons (n = 11), multiple studies were reported simultaneously (n = 5), diagnostic strategies were investigated (n = 2), or in vitro methods were used (n = 1). The analysis comprised the remaining 172 RCTs (Table 2). The median number of participants was 257 (range, 18 to 54 654). Approximately two thirds of the studies were carried out in several settings (multicenter), and about half were sponsored by industry. Pharmaceutical agents (70% of the studies) were by far the most common intervention used.

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Summary for Patients

Reporting the Recruitment Process in Clinical Trials: Who Are These Patients and How Did They Get There?

The summary below is from the full report titled “Reporting the Recruitment Process in Clinical Trials: Who Are These Patients and How Did They Get There?” It is in the 2 July 2002 issue of Annals of Internal Medicine (volume 137, pages 10-16). The authors are C Gross, R Mallory, A Heiat, and HM Krumholz.

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