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The ABC’s of Clinical Trials

Jane N. Winter, M.D.Robert H. Lurie Comprehensive Cancer

CenterFeinberg School of Medicine

Northwestern University

• A study to better – Prevent– Detect – Treat*

…….lymphoma.

*Test the safety and effectiveness of new cancer drugs or drug combinations

What is a Clinical Trial??

Different Kinds…

Why Clinical Trials are Important• To find new

treatments

• To improve our understanding of the biology

• To improve survival and the quality of survival for lymphoma patients!

Types of Clinical Trials

• InterventionalPreventionTreatment

• Non-InterventionalQuality of Life

Who Sponsors Clinical Trials??

• National Cancer Institute– Cooperative Groups – LYSC oversight

(ECOG/ACRIN; Alliance; SWOG)

• Academic Medical Centers– Investigator initiated trials (IIT’s)

• Pharmaceutical Industry– Advisory boards– Investigator initiated trials

• Access to a new therapy –– A new drug– A new combination of standard drugs– A combination of a new drug with a standard

combo

• Standardized treatment (protocol), reviewed by experts

• Help others by advancing science

Why join a clinical trial?

Who can participate in a clinical trial?

• Healthy volunteers• Patients at risk for a specific illness • Patients with a specific disease- e.g.

lymphoma

Understanding eligibility for clinical trials

• Age (children, adults)– Often no age limit

• Specific type of blood cancer: myeloma vs. lymphoma

• Stage e.g. in Hodgkin Lymphoma, Stage 3 or 4• New diagnosis vs previously treated• Specific requirements: e.g. platelet count,

kidney, liver function.• Prior diagnosis of another cancer

Informed Consent

• IRB Review• Process- to provide info

– Rationale for trial – Why?– What?– How long? – Risks and benefits?– Who pays for what?– Confidentiality – who has access to my records?

Phases of Clinical Trials• Phase I

– Best dose?? Dose escalation.• First in human. • How absorbed, metabolized, excreted.

– Safety !!! • Phase II

– Specified dose– Larger number of patients– More safety data; How effective??

• Phase III –head to head comparison (standard vs experimental)

• Phase IV- post-FDA approval

Definitions:• Randomization

• Placebo

• Double blind

Where to find Clinical Trials?

• Ask your hematologist/oncologist?• www.clinicaltrials.gov• www.lymphoma.org• www.lls.org (Trialcheck)• Your local Cancer Center’s website

Myth #1: “I might receive a placebo instead of active treatment*”

Fact: Very few studies involve placebos.

Exceptions: • When there is no standard-of-care treatment

available

• When the standard-of-care is observation

• *In some cases a placebo may be given in combination with a standard-of-care therapy

*The consent will tell you if there is a chance of receiving a placebo

Myth #2: “Clinical trials are not safe”

• Fact: Close oversight to ensure the safety and protection of research participants

• Oversight and monitoring of trials includes:

-Scientific Review Committee-Institutional Review Board-Data Safety Monitoring Board

Myth #3: “Clinical trials are free”Facts:

• Routine costs are the responsibility of patient insurer or patient

• Research costs are the responsibility of the clinical trial sponsor

Myth #4: “My insurance may deny clinical trial treatment”

Facts:With the exception of a few select health plans, insurance carriers: (1) may not deny the qualified individual participation

in an approved clinical trial (2) may not deny the coverage of routine patient costs

for items and services furnished(3) may not discriminate against the individual on the

basis of the individual’s participation in the trial.

Myth #5: “Clinical trials are offered only when there is no hope”

Fact:

Clinical trials are available for all stages of cancer, including newly diagnosed patients

What can I expect if I participate in a clinical trial?

• Structured treatment plan, per protocol• Comprehensive care from a clinical trial team• Responses to treatment, labs and clinic visits

followed closely, per trial protocol • Questionnaires, medication diaries

The bottom line…..

Acknowledgements

My patients and their families