Clinical data management india as a hub

Clinical Data Management India as a Hub

Dr. Bhaswat S. ChakrabortySr. VP & Chair, R&D Core Committee

Cadila Pharmaceuticals Ltd.

Ongoing Clinical Trials in India

Source: clinicaltrials.gov

Clinical Trials: Why Do We Need a Data Management System?

• Multi-centre co-operative trials– Multiple sites capturing data

– Multiple disparate databases

– Multiple levels of reporting

– Critical, very specific information

– Multitude decision making at multiple sites

– Co-ordination demands details

– Real time query and real time response

Investigational Sites

Product Management

Project Management

Drug & Clinical Trial Development

Extended Picture

IRB Regulatory Documents

Relationship Building

eMails

Partners & Affiliates

Meetings

CROs

Contracts

Knowledge

Information

Safety

Communication

Resource Management

Data Capture Data Management

Multidirectional Flow of Data and Decisions

Clinical Trials: Why Do We Need a Data Management System?

• Enormous volumes of data– Example, a Phase-III trial in 10 centres with 100 patients

each – 60 pages of CRF for each recruited patient

• 20 fields each page

– 40 pages of screening form for each candidate patient• 20 fields each page

– [1000 (60 x 20)] + [1500 (40 x 20)] = 12, 00000 + 12, 00000= 24,00000 specific data points

Clinical Trial Data• Useful only if it is clean & up to date. • Data processing must be

– real-time• subject randomization• management of clinical trials materials• laboratory uploads• patient diary data

– Integrated– Consistent– Accurate

• Data structures must be– Standard– Validated

• Data transfer method must be– Standard– Validated

Data Management Services: What Exactly Do They Do?

• Case report forms (CRFs) design • Database design • Database programming • 21 CFR part 11 compliant validation process • Loading, reconciliation and integration of external data • Medical coding • Status reporting • Forms management• Data entry and cleaning• Data locking• Statistical analysis• Report generation

Clinical Data Management System (CDMS)

Data Capture Strategy

Remote Data Capture

Portal Data Capture

Processes

Adverse Event Monitoring System

Compliance (GCP/GLP) Monitoring

Workflow Monitoring

Analytical Data Processing

Statistical Data ProcessingSystems

Data Extraction

GLIB

TMS/Dictionaries

Reports

Validation

Data Capture (1)

No

Yes

CRF

Manual data

Electronic data

Raw data

A

Electronic data to be combined?

Raw data (Manual)

Get approval



Remote Data Capture

Portal Data Capture

Processes



Workflow Monitoring



Data Extraction

GLIB

TMS/Dictionaries

Reports

Validation

A

Data Extraction, Cleaning & Locking (2)

Real time query

Are the queries answered?

Yes

No

Data cleaning1. Detecting & diagnosing errors2. Editing incorrect data3. Integrated data passage4. Outlier determination5. Robust estimation of analytical parameters

Clean data

Approval required

Can this data be locked?

Yes

NoRepeat Observation/

Omission

Locked data B



Remote Data Capture

Portal Data Capture

Processes



Workflow Monitoring



Data Extraction

GLIB

TMS/Dictionaries

Reports

Validation

B

Data Processing & Reporting (3)

Locked Clean Data

Statistical analysis required?

Yes

No

SAS Data SetsStatistical Data AnalysisTests of HypothesesCohort Analyses

ResultsReport

Data Summary, Charts/Graphs

CRF Database

Data Entry Layout

CRF Maker CRF

(Form) Editor

Edited

Hard Copy

Electronic Case Report Forms

Design

Define

Build

Test

Use

Subject Data Entry

(Investig

ational S

ite)

Data Review

Sponsor/Monitor

Central Data

Repository (HUB)

Electronic Data Capture (EDC)21C

FR

Part 11

Co

mp

liance

CDMS Market Size in India

• [Gobally ~$1.5 billion]

• Estimated Indian Market

• The total Clinical Trial market in India is ~$600 million

• CDMS is about 7-8% of CTs

• Thus the CDMS market is estimated to around 40 – 45 million dollars

• For big MNCs, it is still a very small portion

• But it has a huge potential to grow

Clinical Trials Destination: India

Business Models:1. Specialized outsourcing hub2. General hub

Drivers of EDC & CDMS• Context – why India and why EDC & CDMS• Technology & market forces• Cost advantage• Concentration of resources• Expertise (and lathes of expertise)• Regulators are insisting on comprehensive risk

management and PV• Large trials have dozens of international sites and

corresponding chunks of data

Facilitators of EDC & CDMS• Context – why India and why EDC & CDMS• Consultants who can integrate different parts• One stop shopping

– Patients, diversity– investigators– CT conduct experience– Top CROs

• Research subsidiaries of pharma MNCs and int’l CROs• CDMS & EDC offer efficiency and timeliness of data collection

and reporting• Understanding of harmonized data & analysis requirements

Sahoo U. (2005). Clinical data capture shifts paradigm. Pharmabiz, July 14, 2005

Stakeholders in CDMS & EDC

Data Standards & Harmonization• It is estimated that ~ 200 million dollars are wasted yearly

because of a lack of globally accepted clinical data format• Following organizations are working for data standardization:• Clinical Data Interchange Standards Consortium (CDISC)• Health Level 7 (Hl7)• WHO• US National Cancer Institute (NCI)• National Library of Medicine (NLM)• Academia• ISO• …

Jobs in India in CDISC, EDC, Biostats…

Standards for Data Management

• Very important for the regulatory agencies

• Without a standard, sponsors file data in different arrangements

• Once data is in a standardized structure, regulatory agencies can preprogram software to run a macro script

• Thereby data coming from different sources will automatically format to conform to the regulatory agencies requirements

MNC PV Activities & Databases in India

• Example: Novartis• Activities/Databses

– Periodic Safety Update Report (PSUR)– Risk Management Plan (RMP) updates and associated activities– safety signal detection– management of large datasets– analysis of large databases– responses to external authorities– review of clinical protocols– other regulatory activities– clinical review and evaluation of cases including input for follow-up

and data cleaning– ….many other relevant activities

Advantages to MNCs: Outsourcing to India

• Better, safer drugs to market faster• Improve efficiency

• Improve communication• Improve data collection• Reduce redundant data submissions

• Other benefits• Improve communication• Decrease redundant data submission• Decrease “learning curve”• Cross study analysis• User friendly tools• Decrease delays

Technical Advantages• Cloud computing possible• Real-time access to all clinical trial data• Easy filling of e-CRFs with

– Radiobutton choices – Checkboxes – Drop-down selections – Unlimited text boxes for comments

• Real-time data entry validation checks • Secure database • Back-end clinical data management and programmed data

validation checks• Electronic and automatic Audit Trail• Simple e-mail query resolution or by on-line query database• Configurable access rights• Electronic signatures fully compliant with FDA's 21 CFR Part 11

Concluding Remarks• CDMS provide a range of IT tools that give the trials personnel

the required information throughout clinical management

• CDMS mainly manages data capture, systems and analytical process electronically

• EDC definitely adds value – efficiency and accuracy, however, high costs and some technology issues remain

• Technical and automational advantages are countless

• The CDMS market in India is estimated to around 40 – 45 million dollars and growing

• Provides for data standardization and interchange in universally acceptable formats

Concluding Remarks: India as a Hub• India offers many advantages as a CDMS hub

• Cost

• Concentration of resources

• Expertise

• Comprehensive risk management databases, analysis, mitigation and PV centres

• Consolidation of various databases (especially large ones)

• India’s IT sector is growing at ~25% per year thus maintaining complex CDMSs at competitive costs in India is an added advantage

• Abundant skilled personnel in all areas of CDM available• Hub of almost all clinical trial activities in coming years

Thank You Very Much

Clinical data management india as a hub

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