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Q of the week

Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

Clinical Research Industry Associations
APPIAcademy of Pharmaceutical Physicians and Investigators
AdvaMedAdvanced Medical Technology Association
AHRPAlliance for Human Research Protection
AACRAmerican Association for Cancer Research
AAHRPPAmerican Association for the Accreditation of Human Research Protection Programs
AAPSAmerican Association of Pharmaceutical Scientists
ACCPAmerican College of Clinical Pharmacology
ACLMAmerican College of Legal Medicine
AFMRAmerican Federation for Medical Research
AIMBEAmerican Institute for Medical and Biological Engineering
AMAAmerican Medical Association
AMWAAmerican Medical Writers Association
APhAAmerican Pharmacists Association
ASCIAmerican Society for Clinical Investigation
ASCPTAmerican Society for Clinical Pharmacology and Therapeutics
ASQAmerican Society for Quality
ASAAmerican Statistical Association
AECICAsociación Española de Compañias de Investigación Clínica
ACRONAssociatie van Clinical Research Organisations in Nederland
ACDMAssociation for Clinical Data Management [UK]
AGCP-CRDAssociation for Good Clinical Practice and Clinical Research Development [Bulgaria]
AGCPNAssociation for Good Clinical Practice in Nigeria
GCPPLAssociation for Good Clinical Practice in Poland
APORAssociation for Patient-Oriented Research
APPEAssociation for Practical and Professional Ethics
L'AFARAssociation Francaise des Affaires Reglementaires
AFCROsAssociation Francaise des CROs
AHCAssociation of Academic Health Centers
AAMCAssociation of Academic Medical Centers
AAUAssociation of American Universities
AGAHAssociation of Applied Pharmacology [Germany]
ACROAssociation of Clinical Research Organizations
ACRPAssociation of Clinical Research Professionals
ACRO-CzAssociation of CROs Czech Republic
AFDOAssociation of Food and Drug Officials
AIRIAssociation of Independent Research Institutes
ARCSAssociation of Regulatory and Clinical Scientists [Australia]
ABPIAssociation of the British Pharmaceutical Industry [UK]
AUTMAssociation of University Technology Managers
APPAAustralian Pharmaceutical Physicians Association
PHARMIGAustrian Association of Regulatory Affairs
BACRRBay Area Clinical/Regulatory Roundtable
BIOBiotechnology Industry Organization
BrAPPBritish Association of Pharmaceutical Physicians
BARQABritish Association of Research Quality Assurance
BIRABritish Institute of Regulatory Affairs
BVMABundesverband Medizinischer Auftraginstitute (Federal Association of Medical Contractors)
Rx&DCanada's Research-Based Pharmaceutical Companies
CAPRACanadian Association of Pharmaceutical Regulatory Affairs
CAREBCanadian Association of Research Ethics Boards
CMACanadian Medical Association
CSCICanadian Society for Clinical Investigation
CSPSCanadian Society for Pharmaceutical Sciences
CSCRCentral Society for Clinical Research
CMRCentres for Medical Research International [UK]
COGChildren's Oncology Group
CIRCARECitizens for Responsible Care and Research
CCRAClinical Contract Research Association [UK]
CDISCClinical Data Interchange Standards Consortium
CPCClinical Providers Consortium
n/aClinical Research Association (Turkey)
CRACClinical Research Association of Canada
CRFClinical Research Forum
CRRClinical Research Roundtable [Institute of Medicine]
CFHConnecting for Health
CIRBConsortium of Independent Review Boards
CECREConsortium to Examine Clinical Research Ethics
CIOMSCouncil for International Organizations of Medical Sciences
COGRCouncil on Governmental Relations
DIADrug Information Association
DSECDrug Safety Executive Council
ECRINEuropean Clinical Research Infrastructures Network
EUCROFEuropean Contract Research Organization Federation
EUFEPSEuropean Federation for Pharmaceutical Sciences
EFBEuropean Federation of Biotechnology
EFPIAEuropean Federation of Pharmaceutical Industries and Associations
EFSPIEuropean Federation of Statisticians in the Pharmaceutical Industry
EFGCPEuropean Forum for Good Clinical Practice
EMWAEuropean Medical Writers Association
ENMAEuropean National Medicines Authorities
EORTCEuropean Organisation for Research and Treatment of Cancer [Belgium]
ESCIEuropean Society for Clinical Investigation
ESRAEuropean Society of Regulatory Affairs
 FDA Alliance
FDLIFood and Drug Law Institute
GCRFGeneva Clinical Research Forum [Switzerland]
GCP-RMAGood Clinical Practice Records Managers Association [Europe]
DGPharMedGerman Association of Pharmaceutical Medicine
GHTFGlobal Harmonization Task Force
HAIHealth Action International
HCCAHealth Care Compliance Association
HIIHealth Improvement Institute
HRGHealth Research Group [Public Citizen]
ICMRIndian Council of Medical Research
ISCRIndian Society for Clinical Research
ICRInstitute of Clinical Research [UK]
IOMInstitute of Medicine [NAS]
APVInternational Association for Pharmaceutical Technology
IAPPInternational Association of Privacy Professionals
IBPAInternational Biopharmaceutical Association
ICMJEInternational Committee of Medical Journal Editors
ICDRAInternational Conference of Drug Regulatory Authorities
ICHInternational Conference on Harmonisation
IFAPPInternational Federation of Associations of Pharmaceutical Physicians
IFPMAInternational Federation of Pharmaceutical Manufacturers Associations
ISOInternational Organization for Standardization
FIPInternational Pharmaceutical Federation [Netherlands]
ISCBInternational Society for Clinical Biostatistics
ISPEInternational Society for Pharmaceutical Engineering
ISPORInternational Society for Pharmacoeconomics and Outcomes Research
ISPEInternational Society for Pharmacoepidemiology
ISRPTInternational Society of Regulatory Toxicology and Pharmacology
AICROItalian Association of CROs
JPMAJapan Pharmaceutical Manufacturers Association
JCAHOJoint Commission on Accreditation of Healthcare Organizations
AFCROsL'Association Francaise des CROs
MDMAMedical Device Manufacturers Association
MCCMetrics Champion Consortium
MPRAMinority Physicians Research Alliance
NASNational Academy of Sciences
NABRNational Association for Biomedical Research
NACUANational Association of College and University Attorneys
NAIMNational Association of IRB Managers
NCQANational Committee for Quality Assurance
NCCNNational Comprehensive Cancer Network
NCURANational Council of University Research Administrators
NCPIENational Council on Patient Information and Education
NHCNational Health Council
NPCNational Pharmaceutical Council
NCBNuffield Council of Bioethics
TOPRAThe Organization for Professionals in Regulatory Affairs
PPRUPediatric Pharmacology Research Unit Network
PCMGPharmaceutical Contract Management Group
PICRAPharmaceutical Industry Contract Research Alliance
PhRMAPharmaceutical Researchers and Manufacturers of America
PSGPharmaceutical Sciences Group
PCBThe President's Council on Bioethics
PMIProject Management Instititute
PCHRGPublic Citizen Health Research Group
PRIM&RPublic Responsibility in Medicine and Research
RAPSRegulatory Affairs Professionals Society
R!AResearch!America
RACCResearch Administrators Certification Council
RCPRoyal College of Physicians [UK]
SBPPCSociedade Brasileira de Profissionais em Pesquisa Clínica
SIARSocieta Italiana Attivita Regolatorie
SSFASociety for Applied Pharmacological Sciences [Italy]
SCDMSociety for Clinical Data Management [UK]
SCTSociety for Clinical Trials
SMPRSociety for Medicinal Plant Research [Germany]
SMRSociety for Medicines Research [UK]
SRSASociety for Research Subject Advocates
SWHRSociety for Women's Health Research
SoCRASociety of Clinical Research Associates
SPISociety of Principal Investigators
SQASociety of Quality Assurance
SRASociety of Research Administrators International
SRSASociety of Research Subject Advocates
SOTSociety of Toxicology
SACRASouth African Clinical Research Association
PSIStatisticians in the Pharmaceutical Industry
SIDCERStrategic Initiative for Developing Capacity in Ethical Review
SSCTSwedish Society for Clinical Trials
TIPPSAThe Technical Industrial Pharmacists and Pharmaceutical Scientists Association
UKCRCUK Clinical Research Collaboration
WEDiWorkgroup for Electronic Data Interchange
WHOWorld Health Organization
WMAWorld Medical Association

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Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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