CLINICAL TRIAL PROCESSSunitha P.1

CONTENTS

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Introduction to clinical trial process Study Plan Study Implementation Analysis Conclusion

INTRODUCTION

Clinical trial process involves planning, implementing and analyzing clinical study

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Study Plan

Implementation

Analysis

STUDY PLAN4

PROTOCOL DEVELOPMENT

Protocol development and finalization: Protocol is a document that describes the

objectives, design, methodology and statistical considerations of a clinical trial

An outline protocol to describe the basic details of the trial is initially prepared

Written according to GCP standards After number of discussions and meetings,

the protocol is finalized

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INFORMED CONSENT FORM

Informed consent form is the learning the key facts about a trial before deciding whether to participate. Research study purpose Risks/Benefits Alternative treatments Confidentiality of records Medical treatment available if injury occurs Whom to contact for answers to questions Statement that participation is voluntary

Informed consent form is finalized before submitting to the IRB approval

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CASE REPORT FORM

Case report form is a data capture tool used in obtaining data about the subjects

CRF is designed and finalized according to the protocol

CRF can be paper based or electronic Data recorded on the CRFs is used to analyze

the data according to statistical plan and interpret the results

One study can have one or more number of case report forms

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DATABASE DESIGN AND FINALIZATION

Clinical data management encompasses the entry, verification, validation and quality control of data gathered during the conduct of the trial.

The database is designed, tested and finalized before the initiation of the trial

CSV(Computer system validation): All computer systems used in processing and management are validated

CDISC (Clinical Data Interchange Standards Consortium) leads the development of global system independent data standards 8

SITE SELECTION PROCESS

Site selection is based on Access to patient geographic distribution Past performance of site team Capability to recruit anticipated number of

enrollment Availability of required equipment or specialized

staff Confidential Disclosure Agreement (CDA) is

sent to the sites Site Feasibility Questionnaire (SFQ)is sent to

the site

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IRB/IEC APPROVAL

IRB/IEC is an independent body constituted of medical, scientific and nonscientific members

This committee has been designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and well-being of the subjects

All clinical trials require favorable opinion from Ethics committee before site initiation

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INITIATION

STUDY DRUG SUPPLY FINALIZATION

Before the initiation drug supply plan is finalized Matching placebo is also ready Shipment of drug Primary, secondary packing and labeling is ready Blindedness testing, stability testing Storage requirements Site SOP for the inventory, usage and

return/disposal is ready

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STUDY IMPLEMENTATION12

SITE ACTIVATION

Conduct investigator meeting Contract negotiations/agreements Prepare regulatory documents

FDA form 1572, CVs, financial disclosure etc. Provide sites with clinical supplies

Lab kits, drug supply etc.

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Ready

ACTIVATION

INITIAL PATIENT SCREENING

Patients are selected on the basis of inclusion and exclusion criteria

I/E criteria is a screening questionnaire that evaluates the subject’s eligibility to participate in the study

Informed consent form is signed by the subject after the screening questionnaire

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Meets Criteria

INFORMED CONSENT

Eligible subjects are informed about the required information about the study

Informed consent is signed by the subjects after decision

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BASELINE EXAM AND ENROLLMENT

Baseline examination is the assessment taken before the subject is given any treatment Demographic data Physical examination data Clinical data Lab data etc.

The subject is enrolled and randomized into the study after the baseline parameters are taken

The enrolled subject is given the treatment assigned to the study group. 16

DATA ACQUISION AND DATA ENTRY

Data comes from various source documents From Subject - Diaries, self report, questionnaire Investigators - clinical findings Lab test reports – Urine, blood test, ECG etc. Other sources – previous medical records etc.

Data from the source document is entered into the case report forms

Events are coded using standard medical dictionaries

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DATA VALIDATION

Data validation plays key role in discrepancy management

Validation is checking the data for discrepancies and outlier values

Objective for data validation is to assure the validity and accuracy of the data

In case of discrepancy, a DCF (Data Clarification Form) is raised and sent to the investigator

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DCF

DATA CLEANING AND QUALITY CONTROL

After the queries are resolved, the database is updated

The updated database is now ready for the quality check

Quality control procedure is run to assure that the database is clean with no discrepancies

Data listings are reconciled with DCF and CRF Safety data is reconciled with

pharmacovigilance SAE data

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DATABASE LOCK

The database is locked after all corrections are done

A locked database means All discrepancies closed DCFs received and updated coding complete SAE Reconciliation complete

The data is ready to be submitted for analysis

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STATISTICAL ANALYSIS21

STATISTICAL ANALYSIS AND REGULATORY SUBMISSION

Import study data for analysis Statistical analysis is done by SAP (Statistical

Analysis Plan) Primary and secondary outcome measures

are calculated using statistical analysis methods Eg: Mean, t-test and chi-square test etc.

After the statistical analysis, the tables, listings and figures are published

Clinical Study reports are generated for the regulatory submission

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CONCLUSION

Clinical trial process involves careful planning, implementing and analyzing a clinical trial with good practices

A clinical trial must be planned in such a way that the prerequisites are ready in time

After careful planning, the study must be implemented and data must be maintained with high accuracy for the subsequent analysis

Unambiguous conclusion regarding the clinical outcome of the test treatment/device is ideal

One must always strive for the ideal, but in most cases have to settle for the best comprise

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QUESTIONS ?Thank You24