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Clinical trials 101


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Clinical trial slides from May 2016 ocular melanoma (OM) support group at Thomas Jefferson University.

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Clinical trials 101

  1. 1. Tracey Newhall, RN, MSN, OCN Clinical Research Nurse, Thomas Jefferson University
  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.  studies/learn#WhatIs  and-services/cancer-clinical-trials/phases-of- clinical-trials/