Reasons for non-participation in an international multicenter trial of a new drug for tuberculosis treatment.
METHODS
Clinical trials can provide a high standard of patient care and contribute to scientific knowledge; however, only a fraction of the patients screened participate and receive treatment as part of a trial.


OBJECTIVE
To explore reasons why patients were not enrolled in an  international tuberculosis (TB) treatment trial and to compare experiences among study sites.


METHODS
An analysis of reasons why patients were not enrolled was conducted among patients screened for a TB clinical trial at 26 sites in North and South America, Africa, and Europe.


RESULTS
Staff at study sites screened 1119 potential candidates for the trial: 61% (n = 686) were not enrolled due to 1) failure to meet eligibility criteria (n = 405, 59%), 2) site's decision (n = 168, 24%), or 3) candidate's choice (n = 113, 16%). Study staff recorded  a total of 144 reasons for why they believed patients chose not to participate, including concerns over research (28%), conflicts with work or school (21%), and lifestyle and family issues (20%). Socio-demographic and geographic factors also influenced participation.


CONCLUSIONS
Increased  evaluation of screening outcomes and of specific interventions, such as improved education and communication about trial procedures, may increase the efficiency of screening and enrollment in clinical trials.
Uganda-Case Western Reserve University Research Collaboration, Kampala, Uganda. DLamunu@mucwru.or.ug
D
D
Lamunu
K N
KN
Chapman
P
P
Nsubuga
G
G
Muzanyi
Y
Y
Mulumba
M A
MA
Mugerwa
S
S
Goldberg
L
L
Bozeman
M
M
Engle
J
J
Saukkonen
S
S
Mastranunzio
H
H
Mayanja-Kizza
J L
JL
Johnson
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000995:Antitubercular Agents / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D045808:Refusal to Participate / Q000523:psychology* / Q000706:statistics & numerical data; D014376:Tuberculosis / Q000188:drug therapy*; D055815:Young Adult
D000995:Antitubercular Agents