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Clinical Trials: An Overview

Clinical Trials: An Overview. Ted Wun, M.D. Professor of Medicine PI/Director, UC Davis Clinical Translational Science Center Chief, Division of Hematology and Oncology. What Are Clinical Trials?. Research studies involving people

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Clinical Trials: An Overview

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  1. Clinical Trials: An Overview Ted Wun, M.D. Professor of Medicine PI/Director, UC Davis Clinical Translational Science Center Chief, Division of Hematology and Oncology

  2. What Are Clinical Trials? • Research studies involving people • Try to answer scientific questions and find better ways to prevent, diagnose, or treat people with diseases or predisposition to disease

  3. Why Are Clinical Trials Important? • Clinical trials translate results of basic scientific research into better ways to prevent, diagnose, or treat disease • The more people that take part, the faster we can: • Answer critical research questions • Find better treatments and ways to prevent disease

  4. Do Many People Participate in Clinical Trials? • Not enough • For example, only 3 percent of U.S. adults with cancer participate in clinical trials • Nearly 70%+ of pediatric patients participate !

  5. Clinical Trial Protocol A written, detailed action plan that: • Provides background about the trial • Specifies trial objectives • Describes trial’s design and organization • Ensures that trial procedures are consistently carried out

  6. Clinical Trial Design • Eligibility criteria: Can range from general (age, sex, type of cancer) to specific (prior treatment, tumor characteristics, blood cell counts, organ function); eligibility criteria also vary with trial phase • Varies with protocol and phases • Endpoint: Measurable outcome that indicates an intervention’s effectiveness

  7. Phases of Clinical Trials • Phase 1: 15-30 people • What dosage is safe? • How should treatment be given? • How does treatment affect the body? • Phase 2: Less than 100 people • Does treatment do what it is supposed to? • How does treatment affect the body?

  8. Phases of Clinical Trials • Phase 3: From 100 to thousands of people • Compare new treatment with current standard • Phase 4: From hundreds to thousands of people • Usually takes place after drug is approved • Used to further evaluate long-term safety and effectiveness of new treatment

  9. Randomized Trials Participants have an equal chance to be assigned to one of two or more groups: • One gets the most widely accepted treatment (standard treatment) • The other gets the new treatment being tested, which researchers hope and have reason to believe will be better than standard treatment

  10. Randomization

  11. Why Is Randomization Important? • So all groups are as alike as possible • Provides the best way to prove the effectiveness of a new agent or intervention

  12. Types of Clinical Trials • Treatment trials • Prevention trials • Early-detection trials/screening trials • Diagnostic trials • Quality-of-life studies/supportive care studies

  13. Benefits of Participation Possible benefits: • Patients will receive, at a minimum, the best standard treatment • If the new treatment or intervention is proven to work, patients may be among the first to benefit • Patients have a chance to help others and improve care

  14. Risks of Participation Possible risks: • 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 • Health insurance and managed care providers do not always cover clinical trials

  15. Patient Protection • There have, unfortunately, been past abuses in patient protection • Federal regulations ensure that people are told about the benefits, risks, and purpose of research before they agree to participate

  16. How Are Patients’ Rights Protected? • Scientific review • Institutional review boards (IRBs) • Informed consent • Data and Safety Monitoring Boards

  17. How Are Patients’ Rights Protected? • Scientific review • Institutional review boards (IRBs) are required by Federal law for trials that are: • Federally funded • Subject to FDA regulation

  18. How Are Patients’ Rights Protected? Informed consent: • Purpose • Procedures • Risks and potential benefits • Individual rights Informed consent is a process, not a form

  19. How Are Patients’ Rights Protected? 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

  20. Why Do So Few Patients Participate in Clinical Trials? Sometimes patients: • Don’t know about clinical trials • Don’t have access to trials • May be afraid or suspicious of research • Can’t afford to participate • May not want to go against physician’s wishes

  21. Why Do So Few Patients Participate in Clinical Trials? Doctors might: • Lack awareness of appropriate clinical trials • Be unwilling to “lose control” of a person’s care • Believe that standard therapy is best • Be concerned that clinical trials add administrative burdens

  22. Releasing the Results of Clinical Trials • Peer-reviewed journals • Public announcements • Results not made public until end of trial

  23. The Sickle Cell Disease Pipeline What this means in practice: • There are going to be many SCD-related clinical trials in the foreseeable future. • They will all need patients from the same limited population. N>40 SOURCE:; https://clinicaltrials.gov/

  24. Thank you for your willingness to serve your community!

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