CLINICAL TRIALS
Sverker Ljunghall VP Science Relations
AstraZeneca’s commitment to ensuring the highest standards of ethical practice when designing and conducting clinical trials
Clin
ical
tria
ls
Clinical trials in AstraZeneca> Critical to the development of new medicines.
> A candidate medicine enters clinical development only after potential efficacy and safety confirmed in pre-clinical trials.
> All clinical trial proposals are subject to stringent internal review and approval by an external independent ethics committee or institutional review board, and the appropriate regulatory agency.
> 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 global clinical organisation; one set of policies and SOPs*.
* Standard Operating Procedures
Clin
ical
tria
ls
Protocol/PlanningConduct
Reporting
Declaration of Helsinki
ICH-GCP
AstraZeneca SOP
Quality Control
Quality Assurance
Inspections
How it all fits together
Clin
ical
tria
ls
Developing the strategy
Target Product Profile
Target Product Claims
Clinical Development Plan
Clinical Study Protocols
Publications Study Reports
Marketing claims
Doses
Formulations
Ethical considerations
Description ofall proposed
studies(Study Design
Concepts)
Comparators
Overall project
management plan
Probability of success
Risks & contingencies
Defines clinical strategy and activities
Clin
ical
tria
ls
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
> Our standards apply across all geographies and include:> Quality of the study / patient safety> Informed consent procedures> Right to withdraw> Privacy of healthcare information
> Approximately 25% of our clinical studies are conducted by thirdparties – who are contractually required to operate to our standards.
> Our Clinical Quality Assurance teams conduct a wide range of audits of our clinical research activities whether being done in-house or by a CRO.
TOTAL NUMBER OF PATIENTS 60,000West Europe 20,000East Europe 15,000US 10,000Asia 3,500Latin America 3,000Canada 2,500South Africa 2,000Japan 1,000Australia 1,000
Clin
ical
tria
ls
Committed to transparency> Committed to providing relevant information to support best treatment
decisions.
> Publish our hypothesis-testing clinical trials on clinicaltrials.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.gov> Crestor safety information via rosuvastatininformation.com> Participation in the PhRMA Clinical Trials Database
Clin
ical
tria
ls
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
Quality assurance strategy
Clin
ical
tria
ls
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
3 Ad Hoc Analyses• Analyses in Clintrace• DB searches (case series, data-mining)• Analysis of external safety databases (WebVDME on FDA-AERS)
Safety surveillance
SERMProcess
ICR Process Routine SD
Ad HocAnalysis
4 The SERM* Process • Pre-SERM and SERM
Surveillance Process
1 Individual Case Review (ICR)• Electronic Daily Medical Review• Global introspection• GDSP review (‘loop’)• Weekly SUSAR Listing review
* Safety and Evaluation Review Meeting
Clin
ical
tria
ls
Summary
AstraZeneca is committed to:
> High quality clinical research of new medicines that meet patient needs.
> Consistently high standards of clinical trial conduct worldwide.
> Transparency of trial data to inform patients and doctors.
> Ongoing safety surveillance.