Clinical Trials AztraZeneca

8/3/2019 Clinical Trials AztraZeneca

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CLINICAL TRIALS

Sverker Ljunghall

VP Science Relations

AstraZenecas commitment to ensuring thehighest standards of ethical practice whendesigning and conducting clinical trials


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Clinicaltrials

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 internalreview and approval by an external independent ethicscommittee or institutional review board, and the appropriate

regulatory agency.

> All trials must comply with all relevant local laws andregulations and with our own standards which are in line

with international codes such ICHand the Declaration of Helsinki.

> One global clinical organisation;

one set of policies and SOPs*.

* Standard Operating Procedures


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Clinicaltrials

Protocol/PlanningConduct

Reporting

Declaration of Helsinki

ICH-GCP

AstraZeneca SOP

QualityControl

Quality Assurance

Inspections

How it all fits together


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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 of

all proposedstudies

(Study DesignConcepts)

Comparators

Overall

projectmanagement

plan

Probability

of success

Risks &contingencies

Defines clinical strategy andactivities


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Worldwide> Most of our studies are conducted

across a broad geographic span:

> To ensure the diversity of targetted patientpopulations is fully represented

> To help identify those patients for whomthe 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 third

parties who are contractually required to operate to ourstandards.

> Our Clinical Quality Assurance teams conduct a wide range ofaudits of our clinical research activities whether being done in-

house or by a CRO.

TOTAL NUMBER

OF PATIENTS 60,000West Europe 20,000

East Europe 15,000US 10,000Asia 3,500Latin America 3,000Canada 2,500

South Africa 2,000Japan 1,000Australia 1,000


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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

> Crestorsafety information via rosuvastatininformation.com

> Participation in the PhRMA Clinical Trials Database


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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 usingagreed risk assessment criteria

Quality assurance strategy


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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

ICRProces

s RoutineSD

AdHocAnalysis

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


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Summary

AstraZeneca is committed to:

> High quality clinical research of new medicines thatmeet patient needs.

> Consistently high standards of clinical trial conduct

worldwide.

> Transparency of trial data to inform patients anddoctors.

> Ongoing safety surveillance.

Clinical Trials AztraZeneca

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