A GreaterUnderstandingA Practical Guideto Clinical Trials

Solving Insurance and Healthcare AccessProblems I since 1996

A Greater Understanding

Patient AdvocateFoundation• MISSION STATEMENT

standard of care treatment. Each study hasrules about who can and cannot participatesuch as age, sex or stage of disease ."Clinical trials have protocols, or actionplans, for conducting a trial. This helpsthe participant understand what will bedone, how it will be done and why eachpart is needed. In the United States, anindependent committee of physicians(Institutional Review Board), statisticiansand members of the community mustapprove and monitor the protocol. Theymake sure that the risks are small and areworth the potential benefits."(http://www.nlm.nih.gov/medlineplus/clini-caltrials.htrnl '

Patient Advocate Foundation is a nationalnon-profit organization that serves as anactive liaison between the patient and theirinsurer, employer and/or creditors to resolveinsurance, job retention and/or debt crisismatters relative to their diagnosis throughcase managers, doctors and attorneys.Patient Advocate Foundation seeks tosafeguard patients through effectivemediation assuring access to care,maintenance of employment andpreservation of their financial stability.

The purpose of this brochure is to addressquestions surrounding clinical trials. Thesenew treatments need to be studied to makesure they are safe and as effective, or moreeffective, than current standard treatmentoptions. We will discuss what clinical trialsare and insurance issues related to reim-bursement. For more in depth informationplease review, Patient AdvocateFoundation's Lighting the Way ..PracticalGuide to Clinical Trials.

Each trial lists eligibility criteria forparticipation. For example, there arestudies that need volunteers with a certaindisease while others are looking for healthypeople. Some trials want all femaleparticipants while others want all maleparticipants. The sponsor of the studywrites the protocol, which explains what thetrial will do, how the trial will be conducted,location of the study, eligibility criteria, andhow and when the participants will beevaluated. There are many sponsors ofclinical trials. The National Cancer Institutehas a webpage for locating clinical trials aswell as a patient recruitment line to screenpotential patients. Other sponsors includephysicians, single institutions, the Departmentof Defense, the Department of VeteransAffairs,and/or ~opharmaceutical manufacturers.

• WHAT IS A CLINICAL TRIAL

A Clinical Trial is a study of new drugs,combinations of drugs (some already FDAapproved for other purposes) and/ortreatments to see how well they work -especially when compared with current

Clinical trials are done to gather information formany purposes. The purpose of the trial defineshow it will be conducted. There are differenttypes of trials:

Treatment Trials test experimental treatments,new combinations of drugs, and newapproaches to surgery or radiation therapy.

Phase 2: When a drug or treatment advances toa Phase 2 trial, the researchers are studying theresults to determine the effectiveness of the drugor treatment. Phase 2 trials collect informationon the safety and benefit of the treatment. Thestudy expands to 100 or more participants.

Prevention Trials look for better ways toprevent disease in people who have neverhad the disease or to prevent a disease fromreturning. Approaches may include medicines,vaccines, vitamins, minerals, or lifestyle changes.

P ase 3 When a drug or treatment advances toa Phase 3 trial, the researchers are studying todetermine if one treatment is better than another.The trial agent is studied in comparison to currentstandard of care treatment. Phase 3 trialsexpand in size to several hundred to thousandsof participants.

Diagnostic Trials are conducted to findbetter tests or procedures for diagnosing aparticular disease or condition.

hase 4 When a drug or treatment advances toa Phase 4 trial, the researchers are monitoringlong-term safety and effectiveness of the treat-ment. These are also known as Post MarketingSurveillance Studies. 2Screening Trials test the best way to detect

certain diseases or health conditions.

Quality of Life Trials (or Supportive Caretrials) explore ways to improve comfort andthe quality of life for individuals with a chronicillness.'

As a drug or treatment advances in each phaseof a clinical trial the number of institutions, orfacilities, offering the trial increases. Majormedical centers across the nation participate inPhase 2, 3 and 4 trials. In some situations, it maybe possible for you to enroll in a clinical trial at alocal facility.What are the phases of clinical trials?

Clinical trial phases are designed to test thenew treatments being proposed. Phases ofclinical trials go from phase 1 through phase 4.As results are obtained, the trial moves to thenext phase. The 4 phases are as follows ordefined as:

~ When a drug or treatment is in a Phase1 trial, the researchers are studying to determinehow the drug or treatment will be administered(by mouth, through the vein (IV), etc). Theresearchers are looking for the proper dose andmonitoring for side effects. The study focuses ona small group of participants.

In the United States, the FDA (Food and DrugAdministration) requires all new drugs ortreatments complete multiple years of testingbefore approving them for use as standard ofcare. All current drugs have been throughClinical Trial testing at some point to achievethe standard of care label from the FDA. Someconsider clinical trials the most advanced cancertreatment therapy we have. Making the decisionto enroll in a clinical trial is a personal one.Because of advances in medical science,clinical trials can offer you a chance to partici-pate in cutting edge treatments, before they areavailable to th~ general public.

• Age and gender

• Type .ot cancer

• Stage (extent) of the cancer

• Previous treatments that you must, ormust not, have had

• Length of time since you last receivedtreatment

• Results of certain laboratory tests

• Medicines that you are taking

• Other medical conditions

• Previous history of any other cancer

• Other conditions that are specific toeach clinical trial

Investigational. This means the insurancecompany does not recognize the proposedtreatment as a standard of care and will notpay for it. Some policies may cover trials incertain stages - for example, coverage forPhase 3 or Phase 4 trials. This information willbe explained in your insurance policy language.Health plans may specify specific criteria a trialmust meet to be covered. The trial might haveto be sponsored by a specified organization, bejudged "medically necessary" by the health plan,not be significantly more expensive thantreatments the health plan considers standard,or focus on types of cancer for which nostandard treatments are available. In addition,the facility and medical staff might have tomeet the plan's qualifications for conductingcertain procedures, such as bone marrowtransplants.

• How will I know if I am eligible toparticipate in a clinical trial?

Each clinical trial has eligibility criteria, whichare requirements that patients must meet beforethey can participate. Eligibility criteria mightinclude information about:

Many states have passed laws or developedpolicies requiring health plans to cover thecosts of certain clinical trials.For more information, visit the NCI's Web site athttp://www.cancer.gov/clinicaltrials/develop-ments/laws-about -cl inical- trial-costs

If you have found a clinical trial you might qualifyfor, talk to your doctor, or contact the clinicaltrial's principal investigator or research nurse.A member of the study team will ask youquestions about your medical history to see ifyou meet the study's eligibility criteria. Thesecriteria are not used to reject potential participants,but rather to ensure safety. In addition, utilizingthese criteria ensures the information obtainedwill answer the researcher's questions .

Patient Advocate Foundation700 Thimble Shoals Blvd., Suite 200

Newport News, VA 23606Toll Free 1 800-532-5274 Fax: 757-873-8999

Email: help@patientadvocate.orgInternet: www.patientadvocate.org

Publication No. 13 9/2009

• Insurance Issues related to clinicaltrials

Many times participation in a clinical trial requireslearning more about your insurance policy. Manypolicies do not provide coverage for clinicaltrials that are considered Experimental and/or

1 Medline Plus, Clinical Trials. Retrieved2/25/2009 fromhttp://www.nlm.nih.gov/medlineplus/clinicaltrials.html2 Understanding Clinical Trials, retrieved2/28/2009 fromhttp://clinicaltrials.gov/ct2/info/understand

Patient Advocate Foundation is dedicated to ensuringthat all Americans have access to healthcare. CaseManagers are available to assist patients affected bydebilitating or life threatening diseases by empower-ing them to be able to make informed decisionsregarding their healthcare options. For further infor-mation, call the Patient Advocate Foundation at:

1-800-532-5274or visit our website at

www.patientadvocate.org

• Patient Advocate FoundationPublications

• Managed Care Answer GuideAvailable in English & Spanish

• Too Young To Be IILA PracticalGuide for Caregivers of Children andYoung Adults

• Your Guide to the Appeals ProcessAvailable in English & Spanish

• Your Guide to the Disability ProcessAvailable in English & Spanish

• First My IIIness ... Now JobDiscriminationAvailable in English & Spanish

• Promoting a Healthier AfricanAmerican Community

• Lighting the Way...Practical Guide toClinical Trials

• The National Financial ResourceGuide for Patients: A State-by-StateDirectory

• A Greater Understanding ... SeriesA series of 13 pamphlets written toprovide answers to the most frequentlyasked questions regarding healthcare,available for download atwww.patientadvocate.org