Article type
Year
Abstract
Background:
Randomized controlled trials (RCTs) are the best study design for assessing the effectiveness of healthcare interventions.
Objectives:
To describe the characteristics of RCTs on cancer drugs conducted in Spain from 1999 to 2003 based on their protocols. Phase I and phase II non-controlled trials were excluded.
Methods:
This observational retrospective cohort study identified and manually reviewed the protocols of all RCTs on cancer drugs authorized by the Spanish Agency for Medicines and Medical Devices from 1999 to 2003. A descriptive analysis was completed and the association between some relevant variables based on study setting and sponsorship were assessed.
Results:
A total of 303 protocols were identified (60/year on average), which included 176,835 potentially eligible patients. Three-quarters of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). The mean number of expected patients per trial according to the protocols was 591 (SD: 1169), ranging from 15 to 15,000 (median: 328). Compared with their national counterparts, internationally-based studies were significantly larger (P < 0.001) and more often attempted to implement centralized randomization (P = 0.001), blinding of the intervention (P < 0.001), and survival as primary outcome (P < 0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (P < 0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower.
Conclusions:
Oncological RCTs conducted in Spain were much more likely promoted by pharmaceutical companies than by non-profit national groups. They were generally part of international studies and had better methodological quality than the national ones. Non commercial research in Spain needs to be more actively developed.
Randomized controlled trials (RCTs) are the best study design for assessing the effectiveness of healthcare interventions.
Objectives:
To describe the characteristics of RCTs on cancer drugs conducted in Spain from 1999 to 2003 based on their protocols. Phase I and phase II non-controlled trials were excluded.
Methods:
This observational retrospective cohort study identified and manually reviewed the protocols of all RCTs on cancer drugs authorized by the Spanish Agency for Medicines and Medical Devices from 1999 to 2003. A descriptive analysis was completed and the association between some relevant variables based on study setting and sponsorship were assessed.
Results:
A total of 303 protocols were identified (60/year on average), which included 176,835 potentially eligible patients. Three-quarters of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). The mean number of expected patients per trial according to the protocols was 591 (SD: 1169), ranging from 15 to 15,000 (median: 328). Compared with their national counterparts, internationally-based studies were significantly larger (P < 0.001) and more often attempted to implement centralized randomization (P = 0.001), blinding of the intervention (P < 0.001), and survival as primary outcome (P < 0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (P < 0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower.
Conclusions:
Oncological RCTs conducted in Spain were much more likely promoted by pharmaceutical companies than by non-profit national groups. They were generally part of international studies and had better methodological quality than the national ones. Non commercial research in Spain needs to be more actively developed.