Podcast
Questions and Answers
What is the primary purpose of a clinical trial?
What is the primary purpose of a clinical trial?
Which of the following is NOT typically included in a clinical trial protocol?
Which of the following is NOT typically included in a clinical trial protocol?
What types of interventions can be evaluated in clinical trials?
What types of interventions can be evaluated in clinical trials?
What aspect is crucial for ensuring participant safety in a clinical trial?
What aspect is crucial for ensuring participant safety in a clinical trial?
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In clinical trials, which of the following comparisons might researchers make?
In clinical trials, which of the following comparisons might researchers make?
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Which of the following statements about observational studies is true?
Which of the following statements about observational studies is true?
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Which type of trial evaluates only existing treatments without introducing a new intervention?
Which type of trial evaluates only existing treatments without introducing a new intervention?
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Which factor is part of the inclusion criteria in a clinical trial protocol?
Which factor is part of the inclusion criteria in a clinical trial protocol?
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What criteria must be met for a subject to be included in the study regarding the association of periodontitis and Alzheimer's Disease?
What criteria must be met for a subject to be included in the study regarding the association of periodontitis and Alzheimer's Disease?
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In the informed consent process for clinical trials, participants have the right to do what?
In the informed consent process for clinical trials, participants have the right to do what?
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What is the primary purpose of the Investigational New Drug (IND) application to the FDA?
What is the primary purpose of the Investigational New Drug (IND) application to the FDA?
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What role does the European Medicines Agency (EMA) play in the context of rare diseases?
What role does the European Medicines Agency (EMA) play in the context of rare diseases?
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Which of the following could lead the FDA to place a clinical hold on an IND application?
Which of the following could lead the FDA to place a clinical hold on an IND application?
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Which of the following is NOT considered a method to reduce bias in clinical research?
Which of the following is NOT considered a method to reduce bias in clinical research?
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What is an exclusion criterion for the study associated with periodontitis and Alzheimer’s Disease?
What is an exclusion criterion for the study associated with periodontitis and Alzheimer’s Disease?
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Which aspect of research design is essential for ensuring that study results are not influenced by external factors?
Which aspect of research design is essential for ensuring that study results are not influenced by external factors?
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What is the primary goal of Phase I clinical trials?
What is the primary goal of Phase I clinical trials?
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Which statement about Phase 0 trials is correct?
Which statement about Phase 0 trials is correct?
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What is the main focus of Phase II clinical trials?
What is the main focus of Phase II clinical trials?
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What is a significant characteristic of Phase III clinical trials?
What is a significant characteristic of Phase III clinical trials?
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What phase of clinical trials addresses whether a drug may assist patients with a specific disease?
What phase of clinical trials addresses whether a drug may assist patients with a specific disease?
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In what type of study are preliminary effects of a treatment observed on cells grown in a lab?
In what type of study are preliminary effects of a treatment observed on cells grown in a lab?
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Which of the following statements regarding side effects in clinical trials is most accurate?
Which of the following statements regarding side effects in clinical trials is most accurate?
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Why are Phase 0 trials not widely used?
Why are Phase 0 trials not widely used?
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What is the primary purpose of phase III clinical trials?
What is the primary purpose of phase III clinical trials?
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What does the term 'double-blind' signify in clinical trials?
What does the term 'double-blind' signify in clinical trials?
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Why might a phase III clinical trial be halted early?
Why might a phase III clinical trial be halted early?
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Which of the following describes the role of the FDA after phase III trials?
Which of the following describes the role of the FDA after phase III trials?
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What is a randomized trial designed to reduce?
What is a randomized trial designed to reduce?
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What does NDA stand for in the context of drug approval?
What does NDA stand for in the context of drug approval?
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What is NOT a characteristic of phase III clinical trials?
What is NOT a characteristic of phase III clinical trials?
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What is the benefit of a double-blind study in clinical trials?
What is the benefit of a double-blind study in clinical trials?
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Study Notes
Workshop 5: Clinical Trials
- 3rd Medicine, Aa 2024-25, Vittoria Carrabs PhD
- Clinical studies use human volunteers to expand medical knowledge
- Two main types:
- Clinical trials (interventional studies)
- Observational studies
What is a Clinical Trial?
- Research study evaluating safety, effectiveness, and side effects of new treatments, drugs, or medical interventions in humans
- Participants receive specific interventions (e.g., drugs, devices, procedures, behavioral changes) outlined in a protocol
- Comparisons may include a new treatment vs. current standard, treatment vs. placebo, or a comparison between two existing interventions
- Researchers measure outcomes to assess the intervention's impact (e.g., administering a drug to high blood pressure patients to see if it lowers blood pressure)
Clinical Trial - Protocol
- Protocol is a research plan for the trial.
- Protocol details include:
- Rationale (why the study is conducted)
- Participant eligibility criteria (inclusion and exclusion)
- Examples: age, gender, disease type, and prior treatment
- Research design (e.g., control group, methods for bias reduction)
- Treatment details (dose, administration)
- Assessment and data collection methods
- Data review and analysis
- Study duration
- Sample size needed
- Participant information to be collected and recorded
Clinical Trial - Example of Inclusion/Exclusion
- Study on periodontitis and Alzheimer's
- Inclusion criteria: diagnosed Alzheimer's patients, periodontal patients, diagnosed periodontitis subjects, non-periodontal subjects
- Exclusion criteria: pregnant patients, subjects with a history of psychiatric treatments
Clinical Trial - Informed Consent
- Researchers must provide information about the study to potential and enrolled participants.
- Participants choose whether to enroll or continue participating
- Participants can withdraw from the study at any time, even if the study isn't over.
Clinical Trial - Approval by Health Authorities
- Submission of Investigational New Drug (IND) application to FDA before starting clinical research
- FDA review team investigates the IND application (time limit: 30 days) to protect clinical trial volunteers from unreasonable risks
- FDA response:
- Approval for clinical trials
- Clinical hold delaying or stopping the investigation (reasons: unreasonable or significant risks to participants, unqualified investigators, misleading materials, missing information)
Phases of Clinical Trials
-
Preclinical studies (laboratory studies)
- Cell studies ("in vitro" - using cells grown in labs to evaluate treatment effectiveness)
- Animal studies ("in vivo" - treatments studied in animals)
-
Clinical trials phases (used once a treatment shows promise in the pre-clinical studies)
- Phase 0: Test a very small dose on a limited number of people to understand initial drug processing by the body (pharmacokinetics and pharmacodynamics). Not mandatory
-
Phase I: Testing for the optimum dosage with the least side effects in a small group of healthy patients
- Higher doses are given, increasing dosages until side effects become severe, or the desired effect is observed
- Purpose: safety testing
-
Phase II: Further tests safety and effectiveness of the drug for patients with specific diseases in a medium group compared to Phase I
- closely monitors to see if it works
- If the drug works, the next phase can be initiated
-Phase III: Compares the experimental drug to standard drug to see which is more effective and safe
- done in larger numbers of patients
- If the drug shows better results, it can be considered for approval by the FDA -Randomized and double-blind studies are common
-
Phase IV: Trials of the drug after approval
- testing in hundreds or thousands of patients
- looking for short-term and long-term side effects
- evaluating other effects like quality of life and cost effectiveness
- done using observational or registry studies
Clinical Trial - FDA Approval
- New drug application (NDA) is submitted to the FDA upon completion of phase III trials if the new drug is better than the current standard treatments.
- FDA reviews the clinical trial results for approval or rejection of new drug application
- FDA may request further information or additional clinical trials to demonstrate adequate benefits and minimize the new drug’s risks.
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Description
Explore the fundamentals of clinical trials in this informative quiz. You'll learn about the different types of clinical studies, including interventional and observational studies, and how research protocols are developed. Test your understanding of how clinical trials assess the safety and effectiveness of new medical treatments.
