Clinical Trials and YOU

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1 Clinical Trials and YOU

2 What are clinical trials? Controlled studies to determine how a particular anti-cancer strategy ( i.e. treatment ) affects the people who receive it Involve rigorous scientific testing May be randomized

3 Phases of Clinical Trials Phase I ( ): find a safe dosage, build a toxicity profile, determine pharmacokinetics and determine how the agent is to be given Phase 2 ( ~100 ): to determine if the agent has an effect on certain tumor types and to further build toxicity profiles Phase 3 (100s-1000s): Compares an investigational agent against a current standard treatment Phase 4 (1000s): to further evaluate long-term safety and effectiveness ( look for side effects that were not seen in earlier trials ). Also called post-marketing surveillance trial.

4 Types of Trials Treatment: new agents are investigated for their effects on cancer Prevention: interventions (such as drugs, lifestyle changes or diet) are investigated to see if they may prevent cancer from occurring Screening: investigates what sorts of tests may be predictive for a disease as early as possible Diagnostic: investigates new tests to identify a suspected cancer earlier and more accurately Quality of Life: investigates the sorts of interventions that can improve comfort and quality of life of people with cancer

5 Why you may want to consider participating in a clinical trial If a new treatment is proven to work and you are receiving it, you may be among the first to benefit. By looking at all your treatment choices, including clinical trials, you are taking an active role in a decision that affects your life. You have the chance to help others and improve cancer treatment.

6 What to Expect in a Phase I Clinical Trial Informed Consent a document that is signed by a patient/subject, to the degree he/she is capable, to be given the opportunity to choose what shall or shall not happen to them mandated by federal law lays out the course of the study, potential risks and benefits, and purpose of the study even after you sign the consent form, you can leave the study at any time.

7 What to Expect in a Phase I Clinical Trial A lot of information presented to you during your screening/informed consent process! ASK QUESTIONS Added assessments above and beyond what you would normally encounter with an approved therapy Extra blood draws for pharmacokinetics and standard hematological and metabolic labs More frequent visits with your provider than usual, at least until your first scan CT or PET/CT scans every 6-8 weeks to track your disease Side effects: these can be mild or severe but are presented in the informed consent document

8 Costs related to Phase I Clinical Trial Most assessments ARE paid by the sponsor/drug company but you will be responsible for co-pays or other financial obligations that are associated with standard of care assessments ( weekly CBCs, scans, monthly doctor visits ) What is standard of care? A SOC assessment is something which would occur during the course of your treatment irrespective of which treatment you are on.

9 Efficacy in Phase I Clinical Trials Efficacy is not a primary endpoint but definitely a hopeful one Phase I trials are about establishing dosing regimens, building toxicity profiles and looking for any potential efficacy Efficacy MAY be less at lower doses but this is never really known as these agents are first in man. Efficacy is hypothesized from all of the pre-clinical animal data and molecular research

10 Efficacy in Phase I Clinical Trials Newer targeted agents used against patients who possess the target have a much better chance for response Example: ALK mutation in NSCLC Only 5% of all NSCLC patients have this mutation Anyone who has this mutation and is placed on a targeted therapy to it will respond, often dramatically As research uncovers more of these targets, patients will be able to be pre-screened for a battery of targets to determine which treatment will work best for them

11 When is entry into a Clinical Trial appropriate? No further curative options are available or the cancer has developed resistance to standard therapy Patient has a relatively good performance status Patient has relatively good organ function ( kidney, liver and heart ) When patients believe the potential benefits to outweigh the potential risks

12 Things to think about when selecting a clinical trial Costs Will I have to pay for any of the treatments or tests? What costs will my health insurance cover? Daily life How could the trial affect my daily life? How often will I have to come to the hospital or clinic? Will I have to travel long distances to take part? Efficacy What are the possible side effects or risks of the new treatment? What are the possible benefits?

13 How to find and choose the right clinical trial Referral from primary oncologist to a research center

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