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Tuesday, Apr 20th

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Home Cancer Cancer Topics What is a Clinical Trial?

What is a Clinical Trial?

Review boards
  • Scientific review
    • Panel of Experts.
  • Institutional review boards (IRBs)
    • Qualified people to evaluate new and ongoing trials.
    • All institutions that conduct clinical trials must, by law, have a IRB that approves the protocol.
  • Data and safety monitoring boards:
    • Ensure that risks are minimized
    • Ensure data integrity
    • Stop a trial if safety concerns arise or objectives have been met.
Are they Ethical?
  • Yes, in general they are.
  • We (the scientific community) strive to make them so.
  • Guidelines make it easier for us to check up on ourselves!
Are they safe?
  • Yes (usually)
  • There are stringent guidelines in place
  • Safety and toxicity are closely monitored
  • Trials have built-in stopping rules
  • Subjects are indemnified
How can we tell they are done properly?
  • The Declaration of Helsinki
  • GCP guidelines
  • Transparency and good communication
  • Use of Institutional Ethics committees.
Ruby Hall Clinic Cancer Centre
Clinical Trials
A wide variety of clinical trials are performed. These include phase I/II and III studies of new drugs, and ongoing program in supportive care and psychosocial research.

Breast, Lung, Colorectal, Head & Neck, Myeloma, Lymphoma, Prostate cancer studies are under progress in only Ruby Hall Clinic’s cancer centre.

The Protocol
  • A study plan on which all clinical trials are base (recipe or blueprint)
  • Provides background about the trial.
  • Describes trial’s design and organisation
  • Ensures that trial procedures are consistently carried out.
  • Each study enrolls people who are alike in key ways.
The Sponsor
  • Sponsor can be
    • Pharmaceutical company.
    • Co-operative group (NHMRC, TROG, NSABP)
    • Another Investigator
    • Foundation
  • Responsibilities of the sponsor
    • update available data.
    • liaise with the appropriate regulatory bodies
    • communication between trial centre and sponsor
    • monitoring trial at the site
    • Ensuring all data collected
The Investigator
  • Profile
    • Adequate qualifications to conduct research in a given area
    • Necessary resources
    • Sound knowledge of the investigational drug and protocol
    • Sound knowledge of GCP
  • Responsibilities
    • Training of staff
    • Ethics submission
    • Facilities and equipment
    • Resources for data collection
    • Informed consent
    • Reporting of serious adverse events
The Clinical Trials Nurse
  • Patient education
  • Emotional support
  • Management of side effects
  • Source documentation
    • Vital signs
    • Adverse events - CTC
    • Protocol deviations
    • ECOG Performance status
The Clinical Trial Coordinator or Data Manager
  • Responsible for the collection, handling, manipulation, tracking and quality of the data.
  • Ensure
    • clinicians adhere to the protocol,
    • trial patients receive the therapy dictated by the protocol,
  • provide support to the patients
  • All in accordance with Good Clinical Practice (GCP).
What should a patient consider before participating a clinical Trial
  • What is the purpose of the study?
  • Why do researchers believe the new treatment being tested may be effective?
  • What kinds of tests and treatments are involved?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How long will the trial last?
  • Who will pay for the treatment?
  • How will I know that the treatment is working?
  • Can I leave the study after it has begun?


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