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Clinical Trials 101

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A thoughtful presentation on participation in clinical trials from the Thomas Jefferson University team at the 2017 CURE OM Patient & Caregiver Symposium.

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Clinical Trials 101

  1. 1.  The decision to participate in a clinical trial is a very personal one. Your type of cancer, overall condition and priorities are all important in making that decision with your doctor and treatment team.  Here are some of the reasons why people decide to participate in a clinical trial:  Hope – There are no guarantees in a clinical trial. It is a research study designed to test new treatments and learn whether they work, but for many people, trials do offer hope. This is particularly true if you are facing an advanced or difficult-to- treat cancer, or if you have stopped responding to other treatments.  Access – Access to the most innovative therapies. All new cancer treatments are studies in clinical trials and many new agents and approaches are available only through trials before they are approved by the Food and Drug Administration (FDA).  Care – People in clinical trials get the highest quality care and monitoring of their cancers.  Physicians and treatment facilities dedicated to improving treatment – The doctors and cancer center that participate in clinical trials make a commitment to advancing cancer treatment and care.  Progress – By participating in a clinical trial, you contribute to progress in treating cancer. This is true even if the trial does not work for you. Cancer research owes a huge debt to the patients who bring courage, optimism and commitment to being in trials.
  2. 2.  Clinical studies are done to add to knowledge base and develop new therapies and treatments  Interventional: Clinical trials  Receive specific interventions according to research protocol created by investigator  Interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet  Compare a new medical approach to available standard approach  Compare to placebo that contains no active ingredients, or to no intervention  Compare interventions that are already available to each other  Observational:  Review health outcomes in groups of participants  Participants are not assigned to specific interventions  Example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.
  3. 3.  Phase I Trials:  These first studies in people evaluate  How a new drug should be given  How often  What dose is safe  Phase I trial usually enrolls only a small number of patients.  Phase II Trials:  A Phase II trial continues to test the safety of the drug  Starts to evaluate how well the new drug works  Phase II oncology studies usually focus on a particular type of cancer  Phase III Trials:  Test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard or placebo  Typically assigned to standard group or new group at random (like flipping a coin)  Often enroll large numbers of people and may be conducted at many doctor's offices, clinics, and cancer centers nationwide  Phase IV Trials:  Purpose is to evaluate side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in a Phase III clinical trial
  4. 4.  Eligibility  Will I fit the criteria to take part in the study?  Location of the study  How often do I need to be at the hospital?  Ongoing testing during the study and after  Frequency of treatment, tests and follow-up after the study is over  Who will pay for the treatment?  Tests, office visits  Travel  Reimbursement
  5. 5.  Principal Investigator  In charge of carrying out the clinical trial  Clinical Research Nurse  Collects information about baseline medical conditions, side effects, medications for data collections  Coordinates testing/schedules  Refers to social work for assistance  Emotional, Housing, Travel  Clinical Research Coordinator/Data Manager  Inputs data  Coordinates testing/schedules  Social Work  Assists with the psychosocial impact of cancer  Lab Coordinator  Processes and ships specimens
  6. 6.  https://clinicaltrials.gov/ct2/about- studies/learn#WhatIs  http://hospitals.jefferson.edu/departments- and-services/cancer-clinical-trials/phases-of- clinical-trials/
  7. 7.  American Cancer Society’s Clinical Trial Matching Service 800-303-5691 www.cancer.org/clinicaltrials  Cancer Watch 617-856-5900 www.centerwatch.com  Cancer Support Community 800-814-8927 www.cancersupportcommunity.org/clinicaltrials  National Cancer Institute’s Clinical Trial Registry 800-422-6237 www.cancer.gov/clinicaltrials  National Library of Medicine’s Clinical Trials Search www.clinicaltrials.gov  Trials Check www.cancertrialshelp.org/trialcheck
  8. 8.  Cancer Support Community’s (CSC) Resources and Programs are available free of charge. 888-793-9355 or visit www.cancersupportcommunity.org  Cancer Support Helpline 888-793-9355  Open to Options 888-793-9355 or visit www.cancersupportcommunity.org

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