Clinical Research Laws & Guidance

  • The Federal Policy for the Protection of Human Subjects (the official name of the Common Rule). Published 1991 and codified into separate regulations.
  • Heavily influenced by the Belmont Report
  • The Department of Health and Human Services (DHHS) has codified their regulations under 45 CFR part 46 (section which is generally referred to when discussing the “Common Rule”)
  • The Common Rule does the following:
    • Describes the types of research subject to regulation
    • Defines key terms such as research, human subject and minimal risk
    • Requires a written assurance of compliance with the common rule
    • Sets forth requirements for an Institutional Review Board’s (IRB) membership, authority, review procedures, records and criteria for approval

A Cancer Clinical Trial is an important research study that aims to improve the safety and effectiveness of a step-based treatment. It is also:

    • A research study conducted with actual people.
    • A controlled and monitored study in which new drug treatments or new approaches for diagnosing, controlling, or preventing cancers are compared to what is currently available.
    • A study designed to answer key scientific questions that will advance medical knowledge.
    • Always a voluntary choice for participation.

The Four Types of Cancer Clinical Trials are:

    • Treatment Trials: to find superior drugs or test for more effective approaches in using surgery or radiation for treating people who already have cancer.
    • Prevention Trials: to test new approaches, such as certain medications, vitamins, minerals, or food supplements, which may lower a person’s risk of a certain type of cancer. These trials are for reducing the risk of developing cancer in healthy people who do not have cancer or preventing the return of cancer in those who have already had cancer.
    • Diagnostic/Screening Trials: to compare new techniques for finding cancer, especially early-stage cancers.
    • Supportive Care/Cancer Control (also Quality of Life) Trials: to test new ways to improve comfort and quality of life for people with cancer. Some of these trials may also be referred to as “symptom control” trials which address the side effects that often accompany chemotherapy.

The Important Parts of a Clinical Trial are:

    • A Protocol…
      • Provides the blueprint of how the trial is conducted.
      • Defines the trial’s action plan.
      • Explains the purpose of the clinical trial.
      • States the research questions the trial is designed to answer.
      • Defines who is and who is not eligible to participate.
      • Outlines what will be done to the trial. For example, how many of a drug will be given, how often it must be taken, and what medical tests will be required to check on the progress of the study.
    • Eligibility Criteria…
      • Defines the inclusion and exclusion factors to protect participant safety.
      • Ensures that the new treatment or approach is being tested on similar groups of people.
      • Ensures key similarities among participants, i.e. the same type of stage of cancer.
    • An Informed Consent…
      • Is an ongoing process; the participant should receive any new information about the treatment as it is learned.
      • Explains key facts of the clinical trial – what will be done in the trial, what type of therapy will be conducted, i.e. radiation, chemotherapy, variation of drug dosages, and how long the intervention will last.
      • States the potential benefits and potential risks/possible side effects of the clinical trial.
      • Explains what kinds of tests will be conducted (X-rays, blood tests) during the trial to monitor study response.
      • Must be signed by each participant. Individuals can freely decide to take part in a trial.

Why are Participants Randomized?

Participant’s randomization is needed to provide non-biased information for the clinical trial. The randomization process provides random selection of participants (similar to flipping a coin). A clinical trial can have two or more treatment assignments (also referred to as “arms”) that are being examined. For example, a drug study may compare the dosage of “Arm A”, to “Arm B” and to “Arm C”.

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