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AstraZeneca’s commitment to ensuring the highest standards of ethical practice when designing and conducting clinical trials
Sverker Ljunghall VP Science Relations
and the appropriate regulatory agency.Clinical trials in AstraZeneca > Critical to the development of new medicines. > All trials must comply with all relevant local laws and regulations and with our own standards which are in line with international codes such ICH and the Declaration of Helsinki. one set of policies and SOPs*. > One global clinical organisation. * Standard Operating Procedures Clinical trials . > All clinical trial proposals are subject to stringent internal review and approval by an external independent ethics committee or institutional review board. > A candidate medicine enters clinical development only after potential efficacy and safety confirmed in pre-clinical trials.
How it all fits together Declaration of Helsinki ICH-GCP AstraZeneca SOP Quality Control Protocol/Planning Conduct Reporting Quality Assurance Inspections Clinical trials .
Developing the strategy Target Product Profile Target Product Claims Clinical Development Plan Clinical Study Protocols Publications Study Reports Marketing claims Defines clinical strategy and activities Formulations Doses Comparators Description of all proposed studies (Study Design Concepts) Overall project management plan Ethical considerations Risks & contingencies Probability of success Clinical trials .
000 15. .000 2. Clinical trials > Approximately 25% of our clinical studies are conducted by third parties – who are contractually required to operate to our standards.000 10.000 West Europe East Europe US Asia Latin America Canada South Africa Japan Australia 20.500 2.Worldwide > Most of our studies are conducted across a broad geographic span: > To ensure the diversity of targetted patient populations is fully represented > To help identify those patients for whom the treatment will be most beneficial TOTAL NUMBER OF PATIENTS 60.000 > Our standards apply across all geographies and include: > > > > Quality of the study / patient safety Informed consent procedures Right to withdraw Privacy of healthcare information > Our Clinical Quality Assurance teams conduct a wide range of audits of our clinical research activities whether being done inhouse or by a CRO.000 1.000 1.500 3.000 3.
Committed to transparency > Committed to providing relevant information to support best treatment decisions.gov > Crestor safety information via rosuvastatininformation.gov: > Make public all 20 data elements requested by ICMJE > 370 trials have been registered as of 31 August 2007 > Comprehensive AstraZeneca clinical trials website: > Retrospective data since AZ created in April 1999 > Contains results from 361 AZ trials as of 31 August 2007 > Whether favourable or unfavourable to AstraZeneca > Other proactive trial registry: > Serious and life-threatening diseases via clinicaltrials. > Publish our hypothesis-testing clinical trials on clinicaltrials.com > Participation in the PhRMA Clinical Trials Database Clinical trials .
Quality assurance strategy Key Objectives > Fulfil regulatory requirements for independent QA > Add value to the Clinical Function/Business Principles > Single standard of GCP world-wide > Quality assurance programmes directed towards • projects • systems • facilities > Audit group part of clinical “team” but independent • Input to procedures and training .closing the loop • Audits selected based on a calculated risk analysis using agreed risk assessment criteria Clinical trials .
Safety surveillance 1 Individual Case Review (ICR) • Electronic Daily Medical Review • Global introspection • GDSP review (‘loop’) • Weekly SUSAR Listing review 2 Routine Signal Detection • Routine regular review of safety data • Quantitative & qualitative detection methods • Analysis of trend and case series cess ICR Pro Ad An Hoc aly is s R ou tine SD Surveillance Process SERM Process 3 Ad Hoc Analyses • Analyses in Clintrace • DB searches (case series. data-mining) • Analysis of external safety databases (WebVDME on FDA-AERS) * Safety and Evaluation Review Meeting 4 The SERM* Process • Pre-SERM and SERM Clinical trials .
> Consistently high standards of clinical trial conduct worldwide. > Transparency of trial data to inform patients and doctors. > Ongoing safety surveillance. Clinical trials .Summary AstraZeneca is committed to: > High quality clinical research of new medicines that meet patient needs.