Clinical Trial Management Systems

Clinical Trial Management Systems

By Nageswararao. Y

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Clinical Trial Systems – Key Application Areas

Protocol Development Investigator/Site Selection and Trial Preparation Subject Identification and Enrollment Collection, Monitoring and Processing of Data Data Analysis and Reporting Safety and Adverse Event Reporting - Pharmacovigilance Submission for Review by Regulatory Authorities

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Clinical Trial Systems – Stakeholders

Protocol Development – Principal Investigator Trial Sponsor

Investigator/Site Selection and Trial Preparation Sites Trial Sponsor IRB

Subject Identification and Enrollment Sites

Collection, Monitoring and Processing of Data Trial Sponsor Sites

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Clinical Trial Systems – Stakeholders – Cont…

Trial Management Trial Sponsor, Sites

Data Analysis and Reporting Trial Sponsor

Submission for Review by Regulatory Authorities Trial Sponsor to agency

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Clinical Trial Systems – Technology Usage

• Protocol Development – – Word Processing software such as Word, Adobe– Document Management Solutions such as Documentum for organizing

and standardizing the process of protocol development– Protocol Authoring / Modeling tools– Simulation software

• Investigator/Site Selection and Trial Preparation – Excel Sheets– In House Tracking systems to track receipt/ approvals of documents – Internet based software systems

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Clinical Trial Systems – Technology Usage – Cont…• Subject Identification and Enrollment

– Media Advertisements– Databases from local hospitals - – Call centers– Publicly available subject data from organizations such as Center Watch

• Collection, Monitoring and Processing of Data– Clinical Data Management Systems (Paper based)– Electronic Data Capture

• First Generation EDC tools – OCR and OMR (Post Marketing Trials)– Remote Data Entry – IVRS (Interactive Voice Response Systems)

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Clinical Trial Systems – Technology Usage – Cont…

• Second Generation EDC tools– Integrated functionalities with much more clinical trial

process functionalities– Extensive usage of internet– Hybrid systems with 2 modes of operations, online and

offline– Enhanced IVRS– ePRO systems

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Integrated CTMS

Study Management

Site Management

StaffManagement

SuppliesManagement

AdverseEvent Reporting

Medical Coding

SubjectManagement

DocumentManagement

Patient DiaryIntegration

Monitoring

ContractsManagement

DataManagement

Secure

Offl

ine and Online Capability

Data Standards compatible

LAB Data External Interfaces

Regulatory Compliant

Randomization

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Alternative Views of CTMS systems

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Clinical Trial Systems – Study Management

A Program represents the top level in the grouping hierarchy of studies.

Typically a Program is matched to a drug under investigation.

Project maps to an indication or a formulation of the drug.

Project is a collection of multiple studies.

Assign multiple compounds to a program.

Create a Program and the Projects associated with a Program

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Clinical Trial Systems – Study Management – Cont… Organizational Unit defines the sponsors of a study

Sponsor A Sponsor B

Geographical Regions can be added to a study and one of them can be made as the Master geographical region United States (Master) India SriLanka

Historical events may be one of two kinds: event recording triggered by the system, or a user-defined event Creation of this study Creation of a study version Setting or changing the randomization access codes for a study Setting or changing the study status

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Clinical Trial Systems – Study Management – Cont… Set start and end dates for studies

Set Study Objectives – A study can have more than one objective

Set Enrollment Criteria – The list of criteria for including / excluding a subject in a trial

Set Termination Criteria – The reasons for terminating a subject from a study

Set Study Comment – Comments about the study

Manage study design – One of the several clinical trial designs available to conduct a clinical trial

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Clinical Trial Systems – Site/Investigator Management

• Create Sites• Assign a site to a study• Assign an investigator to a study site• Link Patient positions to the site• Maintain Investigator data• Assign Treatments to a site• Creating Strata and Randomization criteria• Creating, Reviewing or Canceling blind breaks

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Clinical Trial Systems – Treatments/ Events and Randomization

Active Substances- Active substances are the New chemical entities which are being investigated

Active Drug- The drug currently under investigation

Treatment Regimen (A systematic Plan) defining the details about a drug’s dosing a single regimen is created combinations of single regimens is a Combination Regimen

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Clinical Trial Systems – Treatments/ Events and Randomization

Timelines, Periods, Sub periods and Phases

Strata and Randomization strata means groupings of patients that have common characteristics;

they are representations of particular expressions of factors.

Randomization is the process of hiding patients’ treatments by assigning treatment patterns to patient positions in an unpredictable order

Patient positions represent potential study participants

Each factor describes a single characteristic, such as sex or age.

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Clinical Trial Systems – Data Management

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Clinical Data Management

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Clinical Data Management

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Study Management – Adverse Events

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Clinical Trial Systems – Adverse Event Management

• Ability to enter and manage Adverse Events and Serious Adverse Event.

• Manage Adverse Event Discrepancy

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Clinical Trial Systems – Oracle AERS

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Clinical Trial Systems – Patient Diary

• Get Quality of Life Questionnaires filled by patients.

• Scheduled and Unscheduled entries - Send reminders to subjects, administer questionnaires, alert them for any invalid entries.

• Patient Compliance Tracking – Enables to track patient compliance by using date time stamps, edit checks and automatic scheduled reminders.

• Data can be secured and provide instant access to Investigators and Sponsors on a 24/7 basis.

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Clinical Trial Systems – External data

Import / Export data between clinical trial systems, AERS systems, Financial and ERP systems

Can be CDISC or non CDISC based data transfer Operational Data can be typically split into Admin, Study, Subject,

Audit trail sections

LAB data can be transferred between LIMS and CTMS

Adverse Event integration would happen with systems like Oracle Clinical

Contracts and other financial data can be transferred from financial and ERP systems

Inventory related information such as Supplies can be integrated with manufacturing controls

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Clinical Trial Systems – External data – Cont…

• Randomization details could be integrated from IVRS based systems

• Contract details could also be retrieved from Document Management systems such as Documentum, ERP systems or Financial systems

• Document management systems like Documentum and Adobe can be integrated with CTMS easily.

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References

http://en.wikipedia.org/wiki/Clinical_Trial_Management_System http://www.medicalnewstoday.com/articles/60535.phphttp://www.microsoft.com/office/showcase/ctm/default.mspx

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Thank you