A thoughtful presentation on participation in clinical trials from the Thomas Jefferson University team at the 2017 CURE OM Patient & Caregiver Symposium.
APM Welcome, APM North West Network Conference, Synergies Across Sectors
Clinical Trials 101
1.
2. 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.
3. 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.
4. 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
5. 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
6. 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
8. 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
9. 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