Healthy Skepticism Library item: 8140

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Publication type: Journal Article

Rolland PD, Kablinger AS.
Recruitment for clinical trials: psychopharmacology research clinic's experience in recruiting for depression studies
ASHP Annual Meeting 1999 Jun; 56:

Abstract:

The purpose of this study was to examine the cost effectiveness of recruitment methods for psychiatric patients in two clinical studies for depression and explore reasons patients were excluded from randomization into clinical trials. Data collection consisted of reports from a database of subjects that had phoned the psychopharmacology research clinic for information about participating in clinical drug studies. Financial information regarding advertising expenses was analyzed from a report of Psychopharmacology Research Clinic expenses obtained from the Department of Psychiatry. For the period December 1997 to April 1998 a total of 355 attempted patient contacts were made, 183 (51.55%) were not screened while 172 subjects (48.45%) were screened. Of the 172 patients who were contacted and screened, 141 (81.98%) were screen failures. Reasons for exclusion included: (a) other excluding diagnosis, 29 (20.57%); (b) drug or alcohol use, 23 (16.31%); © comorbid exclusionary medical illness, 21 (14.89%); (d) using exclusionary prescription medications, 16 (11.35%); (e) not interested, 11 (7.8%); (f) failure to show, 9 (6.4%); (g) cancelled appointment, 9 (6.4%); (h) unknown, 9 (6.4%); (i) unable to contact, 6 (4.3%); (j) no means of transportation, 5 (3.6%); and (k) suicidal, 3 (2.12%). The 29 patients excluded for other diagnoses included: (a) panic or anxiety, 6 (20.7%); (b) not major depression, 5 (16.3%); © mild depression, 5 (17.3%); (d) bipolar disorder, 5 (17.3%); (e) obsessive-compulsive disorder, 4 (13.8%); (f) psychosis, 3 (10.3%); (g) post-traumatic stress disorder, 1 (3.4%). Television advertising expenses were $602.87 for each patient randomized through television advertising. Newspaper expenses were $608.11 and radio expenses were $1,045.50 for each patient randomized by these methods. Radio advertising was considered ineffective in recruiting for these two studies. Additionally, word of mouth and flyers produced higher screening rates and randomization than did radio advertising; therefore, efforts to expand and track these methods were increased. Differential recruitment methods for psychiatric patients by diagnostic class may be possible.