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JEOPARDYJEOPARDY!!

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What is the purpose of clinical trials?

To ask specific scientific questions to find better ways to prevent, detect, or treat

diseases or to improve care for people with diseases 

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What is the number one reason cancer patients participate in clinical trials?

a. The doctor recommended it

b. They saw an ad in the newspaper

c. They did research on their own/found it on the internet

a. The doctor recommended it 

RL Comis, D. Colaizzi and J. D. Miller Cancer clinical trials (CCT) awareness and attitudes in cancer of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Vol 24, No 18S (June 20 Supplement), 2006: 6061

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True or False?

Cancer clinical trials are only for people who have no other

options left.

FALSE There are trials for all kinds of

cancers, from the most advanced to the ones found very early.

Fact

Clinical trials are not only for those patients with the most advanced disease; many patients get first line treatment through a clinical trial.

At first treatment, in the adjuvant setting, at recurrence…

How can we ensure that every patient feels confident to ask, “is there a trial

for me?”

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True or False? New approaches being tested in clinical trials are probably more

effective than the current or standard treatment.

FALSENew methods may or may not be better than

current treatment.

A Phase 3 study goal is to determine whether there is a difference. 

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True or False? The reason clinical trials are done is that no one yet knows if a new treatment…

1. Is safe 2. Is effective 3. Will turn out to be better than the

approaches currently being used  

TRUEThese are also the three phases of clinical

trials.

There Are 3 Phases of Clinical Trials

Phase 1 trials• Is it SAFE?

Phase 2 trials• Does it WORK?

Phase 3 trials• Is it BETTER than what is used now to treat this

cancer?

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True or False? Cancer clinical trials seek to find better types of cancer treatments

FALSEThere are many types of cancer clinical

trials.

Fact: There are Many Types of Clinical Trials

• Treatment– Even as 1st line

• Prevention/chemoprevention

– For primary or secondary cancer

• Diagnostic

• Genetics

• Quality-of-life/supportive care

• Screening and early detection

There are different types of cancer clinical trials

• For people who have cancer

– Treatment

– Genetics

– Quality-of-life/supportive care

• For people at high risk for getting cancer

– Prevention

– Genetics• For people being screened for cancer

Another way to look at it…

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3 percent vs. 70 percent

What is the percentage of adult cancer patients participating in cancer clinical trials

vs. pediatric cancer patients?

More children 0-14 surviving cancer due to CCTs

Very Few People Participate

• Less than 3% of all cancer patients receive treatment through a clinical trial (20% eligible)– Participation rate is even lower among people

of color, older people, and the medically underserved

• who tend to have higher cancer mortality rates than the population as a whole.

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True or False?

In randomized clinical trials, patients are assigned to different groups by an objective group of scientists and

physicians. 

FALSE

Patients are usually assigned through a computer. Neither the patients nor the doctors

can choose the group they want.

In Many Clinical Trials, Participants Are Placed into Different Groups

All have an equal chance to be assigned to one of two (or more) groups:

• One gets the most widely accepted treatment

• The other(s) gets the new treatment being tested, which doctors hope will be better

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True or False?In cancer treatment trials, patients may be

given a placebo instead of being appropriately treated for their cancer.

FALSE Placebos are never used to substitute for

appropriate medical care.

• In cancer treatment trials, everyone gets treated

– Placebos or “sugar pills” are almost never used instead of appropriate treatment

Patients Are Always Treated for Their Cancer

Trial 123

Standard Treatment being studied

Trial 456

Standard & Placebo

Standard & “Zing,” a treatment being

studied

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True or False?

Patients who join clinical trials today aren’t going to benefit from taking part

FALSE While it’s not yet known if the new treatment is going to

work better than what is currently used, patients can and do benefit from participating.

Open to many patients, even for first treatment– “The best management for any patient with cancer

is in a clinical trial.” (NCCN, 2008)

– “Therapies offered through CCTs should ideally be considered the preferred treatment choice for physicians and patients, if they are available” (Institute of Medicine, 2010)

Placebos never used instead of appropriate medical treatment

Helping Individual Patients Today: A High Quality Treatment Option

Chance for survival, 1975-1977, all cancers:

50%

Chance for survival, 1999-2005, all cancers

68%

The only way we will find better ways to treat cancer is through clinical trials…

Also important for future patients

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True or False?In general, doctors will always suggest

cancer trials as a treatment option for a patient who is eligible.

FALSE Both health care providers and patients lack

knowledge about clinical trials.

Cancer Clinical Trials

Researchers “have difficulty” in recruitment and retention, especially among minority groups Up to 30% of phase III trials close early

Referrals (or encouragement) from PCPs, surgeons and non-participating oncologists needs to be better

Poor understanding among patients and members of the public Distrust, fear and suspicion

• Most cancer patients are unaware that clinical trials were a treatment option

• Minorities may be as willing to participate in research but are less likely to be asked

• Consider the “narrow window” of opportunity

Who is Offered the Opportunity to Participate?

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What is the main purpose of a clinical trial protocol?

a. To allow physicians to individualize each patient’s case

b. To ensure high-quality patient care

c. To describe how the study will be carried out

d. None of the above

c. To describe how the study will be carried out

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This is something that ACA mandates…

along with 36 states

What is insurance coverage for patient costs in cancer clinical trials

• Health insurance and managed care providers often do not cover the patient care costs associated with a cancer clinical trial.

– What they cover varies by health plan and by study.

• 36 states currently mandate insurance coverage for these trials.

• Medicare covers many patient care costs in cancer clinical trials.

Fact

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The tragedy of the Tuskegee Study brought this right to all persons participating in any

clinical trial.

a. Randomized study design

b. To be informed about risks

c. Informed consent form

d. Informed consent process

d. Informed consent process

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Why don’t more patients participate in clinical trials?

a. Fearb. Don’t know about them

c. Fear that it won’t be paid for by insurance

d. Mistrust

e. All of the above

e. All of the above

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Why are there restrictions as to who can participate on clinical trials?

a. To protect patients safety

b. To ensure study results are accurate and meaningful

c. To limit trials to a certain number of participants

d. Both a and b

d. To protect patients’ safety and to ensure study results are accurate and meaningful

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In the only study of 6000 cancer patients, this is the percentage that were

actually informed about the possibility of receiving treatment through a

clinical trial.

What is 15%

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20% of all cancer patients;

3% of all cancer patients;

Who is eligible for CCT participation vs. who participates in CCTs?

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What is the Informed Consent Process

The process of providing all relevant information about the trial's purpose,

risks, benefits, alternatives, and procedures to a potential participant.

Informed Consent

They must be told about…

• The purpose

• The procedures

• The risks and potential benefits

• Their individual rights

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FALSE85% of cancer patients surveyed

were uninformed that clinical trials were a treatment option; 75% of them would have been willing to

participate

True or False?

In a national study of 6000 cancer patients, 85% were informed that clinical trials were

a treatment option, but declined to participate.

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True or False?Most patients are uninterested

in participating in research

FALSE

Almost Final Jeopardy

Make Your Wager Now…

Name a barrier for clinical trials from the perspective of a) participating oncologist b)

cancer patient c) primary care provider; d) non

participating oncologist

1 Kinney, A. Y., Richards, C., Vernon, S. W., & Vogel, V. G. (1998). The effect of physician recommendation on enrollment in the Breast Cancer Chemoprevention Trial. Prev Med, 27(5 Pt 1),713-719.

Patient and Physician Barriers to Clinical Trial Access (Source: Cancer Clinical Trials: A Guide for Outreach and Advocacy (NCI) (Unless Otherwise Noted)

Physician Barriers Patient and Environmental Barriers

A physician’s recommendation is often the primary factor influencing patients’ decisions to enroll in a trial.1 Yet, each group of providers involved in patients’ diagnosis and treatment face unique barriers to facilitating patient access to clinical trials. For all Patients For Medically Underserved

Groups in particular *

Participating Oncologists

Non participating Oncologists/ Surgical Oncologists

Primary Care Providers doing diagnostic workup, prior to referral 2

May not offer treatment through a clinical trial to all that would otherwise qualify by: assuming disinterest on the part of

their patients inadvertently discriminating against

older people or the medically underserved3, 4,5

avoiding the subject out of concern they would be seem as insensitive.

May not have the skills, ability or resources to conduct appropriate recruitment within the community6.7 May feel the extra effort required to consent minority patients or the medically underserved is not important for their research.8

May lack awareness of appropriate local clinical trials

May be unwilling to “lose control” of a person’s care

May believe that standard therapy is best, or

May feel that referring to or participating in a clinical trial adds an excessive administrative or cost burden to the practice.

May not feel suited to discuss the topic with patients.9 May lack awareness of appropriate local clinical trials10

May lack awareness11 May lack access May face payment12 or

other logistical barriers May not meet eligibility

criteria May be fearful,

distrusting, or suspicious of research

May believe common myths 13

may have long-standing fear, apprehension, and skepticism about medical research because of past abuses

may hold values and beliefs different from those of Western medicine.

may face language and literacy differences can create additional barriers to effective communication

may have co-morbidities, which disproportionately impact their eligibility 14

*These groups comprise government-designated ethnic and racial groups, including American Indian/Alaska Natives; Asians; African-Americans; Hispanic/Latinos; and Native Hawaiian and other Pacific Islanders. They also include rural residents and people of low income and low literacy.

Awareness Barriers/

Promoters

Knowledge

Attitudes/Beliefs

Self-Efficacy

Organizational Environment

Health Literacy

Opportunity Barriers/Promoters

Provider Knowledge

Provider Attitudes/Beliefs

Eligibility/Exclusions by Design Access

Medical Insurance

Advanced Disease

Co-morbidity

Organizational Environment

Acceptance/Refusal Barriers/Promoters

Perceived Harms/Benefits

Trust in Sponsor/Investigator

Self-efficacy

Altruism

Religious Beliefs

Personal Experience

No Cost Treatment

Financial Incentives

Timing

Opportunity

Awareness Acceptance/

Refusal

Final Jeopardy

Make Your Wager Now…

Name 3 risks and 3 benefits for patients who choose to take part in clinical trials

Final Jeopardy Possible Answers…BENEFITS• Health care provided by leading physicians in the field of

cancer research• Access to new drugs and interventions before they are widely

available• Close monitoring of your health care and any side effects• If the approach being studied is found to be helpful, patient

may be among the first to benefit• An opportunity to make a valuable contribution to cancer

research

RISKS

• New drugs and procedures may have unknown side effects or risks

• New drugs and procedures may be ineffective, or less effective, than current approaches

• Even if a new approach has benefits, it may not work for all

Final Jeopardy Possible Answers…