Perception of Risk through Phases of Drug Research and Development: Questionnaire Survey
- PDF / 8,894,418 Bytes
- 6 Pages / 612 x 792 pts (letter) Page_size
- 77 Downloads / 165 Views
lror Cowlrick, BSc, DMS Therapeutic Head Transplantation,Medical Affairs. Astellas Phanna Europe Ltd. Shines, UK
Rolard Wolf, PbD Head of Biometric Raearch, Ingdstadt, Germany lbomas Hdmrr, MD, PbD Profesor Clinical Phannacdoa, Department for Clinical Trials and Entrepreneurship, Gtjteborg University, Gtiteborg, Sweden
Micbrl Olausson, MD, PbD Professor and Chairperson. Department of Surgmy and Tmnsplantation. Sahlgrensb University Hospital at the Sahlgrensh Acadcmv. Gtiteborn. Sweden
Kry Words Risk perception; Research and development; Benefit vmus risk; Questionnaire survey; Health professionals Corrrspomdrmcr Addrrrr Ivor Cowlrick, Astellas Phanna Europe Ltd. Medical Affairs, Lovett House, hvett Road, Stains TW18 3AZ, UK (email: ivmcowlrick9 eu.as tellas.corn). The opinions expressed in this publication represent the opinions of the contributors and do not reflect the official pdicy ofAstellas Phama or the institutions with which the authors are affiliated.
617
Perception of Risk Through Phases of Drug Research and Development: Questionnaire Survey We used a web-based questionnaire survey to invcsiigate haw employees @ the phannaceutical and allied h d t h industria perceive the importance of difimt stcps within drug rcseardl and development for asscssing the ben6ts and risks of ddopmental drugs to read mmket registrution and enter into d i n i d use. Key outcomes wen that Phmaceutid Pruccsses were seen as leust importmtt while Taxicology was mast importantfdawed by Ch'nid TrialsPhas-
I N T R O D U CTl O N Despite implementation of rigorous preclinical and clinical testing procedures for new drug entities, adverse drug reactions continue to emerge in clinical trials that are considered unacceptable in terms of risk to human research subjects and to patients with the target disease or condition. A high proportion of drug development candidates also fail in clinical trials due to insufficient efficacy (1).Published reviews indicate a declining number of drugs have achieved market authorization in recent years and evidence confirms a high failure rate during drug research and development (R&D) and decline in drug submissions (2-4). What value do individuals charged with making go or no-go decisions in the drug development and regulatory process attach to the safety, efficacy, and quality data of developmental drugs? We set out to design a questionnaire to assess an individual's perception of how important the various steps in drug R&D are in terms of the potential benefit versus risk for a drug to be marketed.
MATERIALS A N D METHODS DEVELOPMENT OF QUEsrrONNAIRE Key steps in drug R&D were identified by reference to the regulatory requirements set by the European Medicines Agency (EMEA) and Food
es 2 Latd3, Safe& and Phannacovigilance, and Clinical Trials Phase 2 Early Nonpammetric analysis s h d that these outcomes were infienced by demogmphics of the selected employee target poplclatiosl. Since this survey was e x p h a t q , we fed the expressed judgments of thestudy population are importantforplanning re
Data Loading...
