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Evaluation of the impact of legal regulations on the quality of trials in Spain
407
Abstracts P12 THE DEVELOPMENT
OF A NATlONAL
PERINATAL CLINICAL FIRST STEP
TRIALS NETWORK
IN CANADA:
THE
Mary Hannah and Sheila Hewson University of Toronto end Per/natal Clinical Epidemiology Unit Womens’ College Hospital Toronto, Canada On December 31, 1990, recruitment ended for a 22 center randomized controlled trial evaluating the effectiveness of a policy of induction of labor in postterm pregnancy. The trial took 5 years to recruit its sample size of 3400 patients. Center investigators agreed that they wished to continue to participate in future multicenter perinatal trials and the development of a network was proposed. We describe one step in the development of this network. After wide consultation, a national workshop and ,a national teleconference, it was agreed that a newsletter would be started to promote communication between and among individuals interested in perinatal clinical trials. A small working group was formed to represent the specialties of obstetrics, neonatology, family medicine and nursing to guide the publication of the newsletter. A database of individuals interested in participating was developed and a logo was drafted. We anticipate that the contents of the newsletter will consist of submissions by members of the network and that the membership will be inclusive rather than exclusive. In future, we hope that the Canadian Perinatal Clinical Trials Network will link with similar networks outside of Canada to exchange information and expertise and to promote the efficient use of multicentre clinical trials to answer questions in the field of perinatology.
EVALUATION
P13 OF THE IMPACT OF LEGAL REGULATIONS
ON THE QUALITY
OF TRIALS IN SPAIN
Fernando Garcia-Lopez The Johns Hopkins University Baltimore, Maryland Background: In 1982, Spain promulgated a regulation requiring review and approval of trials involving drugs before implementation. Objective: To determine the effect of that regulation on the quality of trials. Methods: Trials implemented after the regulation were separated into those approved and those not approved. The two sets were compared with regard to indicators of quality, as obtained from the information in the published manuscripts. The comparison was based on a total of 275 trials, published between 1988 and 1990, and undertaken after 1982. Trials were identified via MEDLINE, EMBASE and a local Spanish database. Among the trials so identified, 77 had been approved and 190 had not been. Trials done before and after the regulation was implemented are also compared. Results: Approved trials, compared to their unapproved counterparts, were more often randomized and masked and more of the published reports included lists of reasons for exclusions and information on consent. Multiple logistic regression analysis of quality scores showed that trials that were approved by the regulation had better quality scores than trials not approved. The odds ratios of higher scores for unapproved trials compared to approved trials were 0.50 (95% Cl: 0.26 - 0.95) for recent trials and 0.34 (95% Cl: 0.16 - 0.71) for old trials. Conclusion: The regulation appears to have resulted in an improvement in the quality of Spanish trials.
CHIROPRACTIC
P14 AND PHARMACEUTICAL TREATMENT FOR MUSCLE TENSION RANDOMIZED CLINICAL TRIAL
HEADACHES:
A
Patrlck D. Bollne Northwestern College of Chiropractic Bloomington, Minnesota Patients who suffer with headaches have utilized chiropractic care as a treatment since the early years of the profession. Several surveys and one controlled clinical trial have shown promising results. The use of pharmaceuticals for the treatment of headache is quite extensive and more thoroughly studied. The purpose
Abstracts P12 THE DEVELOPMENT
OF A NATlONAL
PERINATAL CLINICAL FIRST STEP
TRIALS NETWORK
IN CANADA:
THE
Mary Hannah and Sheila Hewson University of Toronto end Per/natal Clinical Epidemiology Unit Womens’ College Hospital Toronto, Canada On December 31, 1990, recruitment ended for a 22 center randomized controlled trial evaluating the effectiveness of a policy of induction of labor in postterm pregnancy. The trial took 5 years to recruit its sample size of 3400 patients. Center investigators agreed that they wished to continue to participate in future multicenter perinatal trials and the development of a network was proposed. We describe one step in the development of this network. After wide consultation, a national workshop and ,a national teleconference, it was agreed that a newsletter would be started to promote communication between and among individuals interested in perinatal clinical trials. A small working group was formed to represent the specialties of obstetrics, neonatology, family medicine and nursing to guide the publication of the newsletter. A database of individuals interested in participating was developed and a logo was drafted. We anticipate that the contents of the newsletter will consist of submissions by members of the network and that the membership will be inclusive rather than exclusive. In future, we hope that the Canadian Perinatal Clinical Trials Network will link with similar networks outside of Canada to exchange information and expertise and to promote the efficient use of multicentre clinical trials to answer questions in the field of perinatology.
EVALUATION
P13 OF THE IMPACT OF LEGAL REGULATIONS
ON THE QUALITY
OF TRIALS IN SPAIN
Fernando Garcia-Lopez The Johns Hopkins University Baltimore, Maryland Background: In 1982, Spain promulgated a regulation requiring review and approval of trials involving drugs before implementation. Objective: To determine the effect of that regulation on the quality of trials. Methods: Trials implemented after the regulation were separated into those approved and those not approved. The two sets were compared with regard to indicators of quality, as obtained from the information in the published manuscripts. The comparison was based on a total of 275 trials, published between 1988 and 1990, and undertaken after 1982. Trials were identified via MEDLINE, EMBASE and a local Spanish database. Among the trials so identified, 77 had been approved and 190 had not been. Trials done before and after the regulation was implemented are also compared. Results: Approved trials, compared to their unapproved counterparts, were more often randomized and masked and more of the published reports included lists of reasons for exclusions and information on consent. Multiple logistic regression analysis of quality scores showed that trials that were approved by the regulation had better quality scores than trials not approved. The odds ratios of higher scores for unapproved trials compared to approved trials were 0.50 (95% Cl: 0.26 - 0.95) for recent trials and 0.34 (95% Cl: 0.16 - 0.71) for old trials. Conclusion: The regulation appears to have resulted in an improvement in the quality of Spanish trials.
CHIROPRACTIC
P14 AND PHARMACEUTICAL TREATMENT FOR MUSCLE TENSION RANDOMIZED CLINICAL TRIAL
HEADACHES:
A
Patrlck D. Bollne Northwestern College of Chiropractic Bloomington, Minnesota Patients who suffer with headaches have utilized chiropractic care as a treatment since the early years of the profession. Several surveys and one controlled clinical trial have shown promising results. The use of pharmaceuticals for the treatment of headache is quite extensive and more thoroughly studied. The purpose