Benefit from participation in clinical trials

Benefit from participation in clinical trials

E.-M. Genss¹, H. Sommer¹, W. Janni¹, M. Kiechle², N. Harbeck², B. Rack¹, K. Annecke², J. Jückstock¹, M. Heinrigs¹, K. Friese¹

¹I. Frauenklinik, LMU München, Germany ²Frauenklinik, Klinikum Rechts der Isar der TU München

Back: The ADEBAR study, a prospect. multic. Ph. III trial to exam. whether high-risk breast cancer pat. (> 4 axill. LN) benefit from a sequent. anthracycl.-docetax. regimen compared to standardther. with anthracycl.. 33 pat. per month had been recrut. by 198 activ. recrut. centers. Meth: A standard. questionnaire to all particip. centers should find out how far treatment and patient care are affected by particip. in this study and comprised 5 questions: prev. inclusion of pat. at the same Tu.- stage in studies, the type of chemo. received by comparable pat. prev. to the study, change in the intens. of medic. care since particip. in the study, the inform. gained through particip. in the study and changes in the overall quality of medic. care. Res.: 51.0% (n=98) of the quest. were returned. 3 of the ret. quest. were not included in the analysis. In the year preceding the study, 63.2% of particip. centers had not entered their high-risk pat. into a clinic. trial, 44.2% of pat. with the same indic. had received inadeq. therapy by today’s standard, 59.0% of the centers noted an increase in the intensity of pat. care as a result of participat. in the study, independ. of the care provided purely because of the study. With a regular flow of information via newsletters, study meetings, etc., 80.0% noted an improvem. in their profess. knowledge in the field of breast cancer. 31.6% of the centers reported an improvem. in the overall quality of their patient care since the start of the trial. Conclus: The results of the survey demonstr. that both physicians and pat. benefit from particip. in clinical trials as this is associated with optimized therapeutic decision-making and pat. care.