Cancer Support Group

Tuesday, Apr 20th

Last update:06:42:40 AM GMT

Home Cancer Cancer Topics What is a Clinical Trial?

What is a Clinical Trial?

Early detection/screening/diagnosis
  • Early-detection trials/screening trials.
    • Test the best way to detect early cancer.
      • Pap smears, Mammograms.
      • Blood tests, X-rays.
    • Detect disease at an earlier stage, resulting in improved outcomes.
  • Diagnostic Trials.
    • Develop better tools for classifying types and phases of cancer and managing patient care.
    • Usually include people who have signs or symptoms.
  • Quality-of-life/supportive care studies.
    • Aim to improve comfort and quality of life for patients and their families.
  • Genetic trials
    • Determine how one’s genetic makeup can influence detection, diagnosis, prognosis, and treatment.
    • Broaden understanding of causes of cancer.
    • Develop targeted treatments based on the genetics of a tumor.
What happens in a clinical trial?
  • Clinical research team check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
    • Tests.
    • Doctors visits.
    • Frequent follow up.
Who can participate in clinical trials?
All clinical trials have guidelines about who can participate. Exclusion / inclusion criteria help produce reliable results Criteria based on factors such as.
  • Age / Gender.
  • Type and stage of disease.
  • Previous Treatment.
  • Medical conditions.
Do Many People Participate in Cancer Clinical Trials?
  • Less than 5% of Adults with cancer participate in clinical trials.

Barriers to Participation in Clinical Trials
Physicians and other health professionals may:
  • Be unaware of appropriate trials.
  • Be unwilling to lose control of patient’s care.
  • Believe that standard therapy is best.
  • Believe that clinical trials are more work.
  • Have concerns about the patient’s care or how the person will react to suggestion of clinical trial participation.
Patients May:
  • Be unaware of clinical trials.
  • Lack access to trials.
  • Fear, distrust, or be suspicious of research.
  • Have practical or personal obstacles.
  • Be unwilling to go against their physicians’ wishes.
Benefits of Participation in Clinical Trials
  • At a minimum, the best standard treatment
  • Early access to new treatments. If the new treatment or intervention is proven to work, patients may be among the first to benefit.
  • Participation in advancing medical knowledge. Patients have a chance to help others and improve cancer care.
  • Active role in own health care.
  • The medical team conducting the trial will carefully and regularly monitor the patient’s progress
Risks of Participation in Clinical Trials
  • New treatments or interventions under study are not always better than, or even as good as, standard care.
  • Even if a new treatment has benefits, it may not work for every patient.
  • Unpleasant, serious or even life threatening side effects.
  • May require more time and attention than a non-protocol treatment.
How Are Patients’ Rights Protected?
  • Ethical and legal codes that govern medical practice also apply to clinical trials.
  • Informed Consent
  • Review Boards
    • Scientific Review
    • Institutional Review Boards (IRBs)
    • Data Safety and Monitoring Boards.
Informed Consent
  • Informed consent is a document designed to inform the patient of the purpose and design of a clinical study, possible side effects and benefits and if there are any other options. It should also include information on
    • Voluntary Participation
    • Duration of Trial
    • Insurance and Compensation
    • Name and Phone Number of Contact Person
    • Procedures
    • Individual Rights and Confidentiality.


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