[Influence of gender on clinical research].
OBJECTIVE
To analyze clinical trials performed in our setting for the past three years from a gender-related standpoint.


METHODS
A retrospective study of 101 trials in which the pharmacy department of a 1,240-bed university hospital took part.


METHODS
protocols and summary reports by the pharmacy department, Gecos software program, trial follow-up cards, reception records, sample dispensation and returns, and yearly reports.


RESULTS
17 trials included women only, 13 trials included men only, and 71 trials included patients of both genders. In female-only trials the most commonly studied condition was breast cancer (70.6%), the most common phases were phase III (47.1%) and II (41.2%) and the most commonly studied drugs were docetaxel (17.7%) and trastuzumab (11.8%). In male-only trials the most commonly studied condition was erectile dysfunction (92.3%), the most common phase was phase III (76.9%) and the most commonly studied drugs were tadalafil (38.5%) and vardenafil (30.8%). In trials without gender-related inclusion criteria the most commonly studied conditions included colon cancer (11.3%), lung cancer (11.3%), and renal failure (9.9%); the most common phase was phase III (57.7%) and the most frequently assayed drugs were interferon alpha-2a, gemcitabine and ribavirin. Overall participation rate was 62.3% for males and 37.7% for females.


CONCLUSIONS
a) Regardless of gender, the most commonly studied condition was cancer, with breast cancer being most common in female-only trials and erectile dysfunction in male-only trials; b) male and female participation followed a 2:1 ratio in trials without gender-related inclusion criteria; and c) phase III was most common amongst all trials considered, with phase II having a relevant role in women-only trials as per guidelines favoring inclusion in early trials.
Arenere Mendoza
M
M
Servicio de Farmacia, Hospital Universitario Miguel Servet, Zaragoza. marenere@terra.es
Cilveti Sánchez
U
U
Idoipe Tomás
A
A
Izuel Rami
M
M
Navarro Aznárez
H
H
Palomo Palomo
P
P
D035843:Biomedical Research / Q000706:statistics & numerical data*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D011287:Prejudice; D017678:Sex Distribution; D012737:Sex Factors; D013030:Spain