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    Stakeholders in Clinical Research

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    suri333
    This document provides an overview of stakeholders in clinical research including their motivations, careers, roles, and responsibilities. It discusses the major players such as sponsors, contract research organizations, investigators, ethics committees, and regulatory authorities. Various careers in clinical research are described like clinical research associates, project managers, and coordinators. It also outlines how clinical trials are conducted and financed.

    Copyright:

    Attribution Non-Commercial (BY-NC)

    Stakeholders in Clinical Research

    Uploaded by

    suri333
    1K views37 pages
    This document provides an overview of stakeholders in clinical research including their motivations, careers, roles, and responsibilities. It discusses the major players such as sponsors, contract research organizations, investigators, ethics committees, and regulatory authorities. Various careers in clinical research are described like clinical research associates, project managers, and coordinators. It also outlines how clinical trials are conducted and financed.

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    © Attribution Non-Commercial (BY-NC)

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    This document provides an overview of stakeholders in clinical research including their motivations, careers, roles, and responsibilities. It discusses the major players such as sponsors, contract research organizations, investigators, ethics committees, and regulatory authorities. Various careers in clinical research are described like clinical research associates, project managers, and coordinators. It also outlines how clinical trials are conducted and financed.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    1K views37 pages

    Stakeholders in Clinical Research

    Uploaded by

    suri333
    This document provides an overview of stakeholders in clinical research including their motivations, careers, roles, and responsibilities. It discusses the major players such as sponsors, contract research organizations, investigators, ethics committees, and regulatory authorities. Various careers in clinical research are described like clinical research associates, project managers, and coordinators. It also outlines how clinical trials are conducted and financed.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    of 37

    Stakeholders in clinical research

    Motivation to involve in clinical research:


    Learn about new diseases. Work with the cutting edge of technology New career opportunities. Improve patient care $$$

    Careers in Clinical Research

    Clinical Research Associate

    Clinical trial project manager

    Clinical Research Investigator


    Study Coordinator Data manager Biostatistician Regulatory affairs manager

    Clinical research Manager


    Business development manager Clinical IT Clinical Business Analyst Drug safety specialist

    Clinical trial auditor

    Clinical Trials Players


    Regulatory Authority

    Overseas Local
    CRO Central Lab Ethics Committee
    IDMC

    SMO/ARO

    Sponsor

    Investigator

    Subjects
    4

    There are four major clinical trial players


    Regulatory authority local & overseas
    Sponsor + CRO, Central Lab

    Investigator + team members & patients +ARO/SMO


    Ethics committee + IDMC

    Clinical trial are performed under the supervision of a doctor and/or researcher
    Maybe located at:
    Hospitals Private specialist clinics

    General Practices
    Research institutes

    Academic institutions
    Other health providers
    6

    Financing of Clinical Trails


    Patient foundations or medical institutions Government agencies eg: NIH, NIC Commercial sponsor Private companies

    Public listed companies


    Venture Capitalists/ Business Angels Licensing partners Private monies
    7

    Sponsor

    Sponsor: Can be an individual, a company, (pharmaceutical, device or biotech) or a academic organization that initiates a clinical trial.

    A recent trend has been for industry sponsors to partner with agencies such as the National Institutes of Health and manage trials

    In investigator-initiated trials, the investigator takes on all responsibilities of sponsor and investigator.
    8

    Sponsor responsibilities may include:


    Protocol development and IND submission Select qualified principal investigators, monitors and sites. Ensure compliance with regulations Inform FDA and PIs regarding adverse events and safety reporting Monitor data for safety and efficacy Provide study supplies and/or investigational product

    Perform data analysis and report findings

    Contract Research Organization (CRO)


    CRO is an organization that performs any or all of the duties of
    a sponsor.

    For FDA regulated trials, the sponsor is required to describe in


    writing exact responsibilities and obligations transferring to

    CRO.
    10

    Project Manager
    The project manager is responsible for monitoring the overall progress of the trial. He/She is in changer of all the reporting to FDA, budgets, cost control and global

    trial communications

    Medical Monitor
    He is individual with therapeutic expertise Involved in protocol development, safety reporting, interpretation of data and clinical findings.
    11

    Data Manager

    He overlooks all the data collected from the trials. Generate data queries to ensure quality of data Maintain ongoing data entry, monitor data analysis and provide reports.

    Statistician

    He analyzes the data from the trial and provides reports for data safety monitoring board (DSMB) or Endpoint committee
    12

    Clinical Research Associate


    Definition:

    Clinical Research Associates are research professionals carrying out activities that may include investigational site selection, set up, initiation, monitoring and close-out, and can be involved in all operational aspects of

    the clinical phases of drug development

    13

    CRA -Role & Functions


    Selection of Principal investigator Liaison between the trial site and the regulatory bodies i.e. IRB, FDA Setting up and designing documentation. Investigator meetings Trial site initiation, monitoring, close-out Training of site staff Financial management and negotiations with sites. Check for adherence to protocol, verify data, adverse events
    14

    Routes to becoming a CRA


    Administrative Clinical trials administrator (CTA) Project assistant Clinical data co-coordinator

    Laboratory work QA (GMP/GLP)


    Trainee program Nursing Clinical trials co-coordinator Research nurse
    15

    Typical work activities can include:


    Developing, writing and presenting the clinical trial protocols. Setting up the study centers -ensuring each center has the trial materials

    Monitoring the trial throughout its duration


    visiting the study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise

    Validating and collecting completed CRFs from hospitals and general practices
    Discussing results with the statistician.

    The specific duties a CRA performs can vary tremendously from company to company.
    16

    Working conditions
    CRAs spend a limited amount of time in the office
    Most of the CRA job includes travelling to the trial sites. Most of the CRAs work independently CRAs can be home based, part time or free lance

    17

    Investigational Site Team


    Principal Investigator
    CRC

    18

    Investigator (PI)
    The PI is the individual who conducts, supervises and is responsible for all aspects of a clinical trial. They are responsible for ensuring regulatory, GCP compliance in trial conduct. The PI will be directly involved in: Treatment of research subjects Supervising the medical staff participating in the study

    Timely review of all clinical and laboratory data


    Reading and interpreting clinical procedures Ensuring proper adverse event reporting and assessing causality of all adverse events

    Ensuring proper study product management


    Performing physical exams and any other required physician procedures Meeting with study monitor when needed, verifying subject data
    19

    Sub-Investigator
    Clinicians who assist the PI in conducting the trial.

    As a practical matter, NPs and PAs who make clinical decisions regarding study subjects should be listed as sub-investigators as well.

    20

    CRC Clinical research coordinator


    The definition of clinical research coordinators: A Clinical Research Coordinator, Study Site Research Nurse or Study Site Coordinator, works at a clinical research site under the immediate direction of a Principal Investigator, whose research activities are conducted under GCP regulations. The CRC is a vital link between the research subjects, the Investigators and other site members. Association of Clinical Research Professionals
    21

    Roles and responsibilities of CRC


    The ICH GCP has not defined the roles and responsibility of the CRC due to which the CRC responsibilities are not well defined. CRC responsibility defers from institution to institution and what the Principal Investigator delegates.

    22

    Typical CRC job responsibilities include:


    Ensure adherence to the protocol and document breaches or violations with sponsor and IRB

    Liaison with sponsor/CRO in site selection, study initiation, conduct and completion.
    Collaborate with PI and facility Complete all regulatory and IRB submissions Develop study source documents, visit schedules, pre-screening questionnaires, logs, forms, letters and regulatory files Determine storage and supply needs Screen, enroll subjects and schedule study visits.
    23

    Typical CRC job responsibilities include continued


    Document all written and phone correspondence with sponsor, labs, IRB, other regulatory organizations Maintain organized, accurate, and complete subject study records including source documents, correspondence, and case report forms (CRFs) Conduct study in manner to ensure integrity of data and safety of subjects Perform study related procedures and collect data Accurately report and track adverse events Ensure proper study product storage and accountability
    24

    The Safety Squad


    IRB

    Data Safety Monitoring Boards (DSMB)


    Food and Drug Administration (FDA)

    25

    IRB
    Institutional Review Board (IRB) or Independent Ethics Committee (IEC) A specially constituted board established to protect rights, safety and well being of human subjects participating in clinical trials.

    May be a part of an institution or independent/private IRB

    26

    Data Safety Monitoring Boards (DSMB)


    An independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved

    27

    Responsibilities of the Data Monitoring Committee


    The DMC may perform a variety of tasks in meeting its overall responsibilities for safeguarding trail participants and trial integrity.
    These tasks may address primarily scientific issues, such as an advisory review of the study protocol, as well as primarily practical issues such as quality assurance.

    Trials may be considered for early termination based on proven efficacy, unfavorable results ruling out benefit, safety concerns, or low probability of achieving the trial objectives.
    All trials monitored by a DMC should function under a charter, agreed to by the trial sponsor and the committee members, that describes the structure and operation of the committee.
    28

    USFDA
    Food and Drug Administration (FDA) The US regulatory authority in charge of review and approval of drug applications, dissemination of safety information and conducting audits or inspections of any sector of clinical research including sites, sponsors, or IRBs. (In US ).

    29

    Potential employers
    Pharmaceutical companies CRO ( contract research organizations)

    Research organizations
    Academic organizations

    Biotechnology companies
    Research laboratories

    Hospitals
    Government organizations
    30

    Clinical Collaborations:
    Contract Research Organizations Site Management Organizations Academic Medical Centers Physician Practice Management Organizations Physician Networks National Organizations
    31

    Services offered by Contract Research Organizations (CROs)


    Full service clinical research enterprises Protocol development: Phases I, II, III, IV Statistical and data management support Monitoring Analysis and manuscript writing Regulatory Submissions/ filing Outsourced research from sponsors Data belongs to the sponsors
    32

    SMO
    Site Management Organizations (SMOs) Site service clinical research enterprises Site selection Entry into trials Training, enrollment, communication Evaluation

    Maintenance
    Human Resources
    33

    Academic Medical Centers (AMCs)


    Hybrids of CROs and SMOs Site Management personnel Safety Desk Training Consortia Development

    Protocol Development
    Data management, statistical analysis Manuscript FDA filing Data is owned jointly between sponsor and AMC
    34

    Physician Networks
    Physician affiliations of interest

    Generally are specialty specific


    Offer greatest freedom

    35

    Physician Networks
    May be organized as a cooperative group that is clinically oriented towards a common goal.
    Examples:

    American College of Surgeons Oncology Group


    Cooperative Outcomes Group in ENT

    36

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