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

1. Tracey Newhall, RN, MSN, OCN
Clinical Research Nurse, Thomas Jefferson University

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.  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.  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.  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.  https://clinicaltrials.gov/ct2/about-
studies/learn#WhatIs
 http://hospitals.jefferson.edu/departments-
and-services/cancer-clinical-trials/phases-of-
clinical-trials/