RESUMO
Global introspection is considered an unreliable method for attribution of causality of serious adverse events (SAEs), yet remains widely used for cancer drug clinical trials. Here, we compare structured case abstraction (SCA) to the routine method for detecting, evaluating, and reporting ADEs during cancer drug clinical trials to an Institutional Review Board (IRB). We obtained all SAE reports (2001-2008) received by one IRB for six clinical trials involving bevacizumab or oxaliplatin for treatment of gastrointestinal cancers. We compared the routine IRB SAE method to SCA for adverse event detection and causality attribution. Of 205 adverse events, 182 events (75%) were not reported; of these, 6 (20%) of 30 SAEs requiring an IRB report were unreported. For the 10 item Naranjo score, the amount of information useful for causality attribution was higher with SCA than the routine method (6.0 vs. 2.4 items, P < .0001). One-fifth of SAEs requiring an IRB report were unreported to the IRB via the routine method. SCA provided more useful information as to whether an SAE was caused by a cancer drug exposure. Our results suggest that SCA may improve SAE detection and the accuracy of attribution of causality during cancer drug clinical trials.
Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Anticorpos Monoclonais Humanizados/efeitos adversos , Antineoplásicos/efeitos adversos , Neoplasias Colorretais/tratamento farmacológico , Compostos Organoplatínicos/efeitos adversos , Neoplasias Pancreáticas/tratamento farmacológico , Bevacizumab , Ensaios Clínicos como Assunto , Comitês de Ética em Pesquisa , Humanos , Oxaliplatina , Estados UnidosRESUMO
PIP: The Commercial Contraceptive Marketing Program was developed by the Population Center Foundation in the Philippines to increase participatio n of private commercial firms in promotion and distribution of nonclinical contraceptives. The program was started to eliminate ignorance concerning contraceptive methods, to increase contraceptive acceptance, and to decrease dropouts from the program. It is hoped that all 200,000 sari-sari stores in the Philippines will eventually become involved in marketing contraceptives. This will free government personnel for the work of extending family planning services to the rural areas. The history of the development of a plan for commercial marketing of condoms in the Philippines is discussed.^ieng