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How to Find and Access Clinical Trials

How to Find and Access Clinical Trials. New Treatments, No Tricks A Seminar on Minority Participation in Clinical Trials June 15, 2010. Before You Start: Understanding Clinical Trials (What they are, Why they are important, The risks and benefits to participating).

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How to Find and Access Clinical Trials

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  1. How to Find and Access Clinical Trials New Treatments, No Tricks A Seminar on Minority Participation in Clinical Trials June 15, 2010

  2. Before You Start: Understanding Clinical Trials (What they are, Why they are important, The risks and benefits to participating)

  3. What Is a Clinical Trial? • Clinical trials are an important part of the research process. • A clinical trial is a research study • Conducted with people • As compared to laboratory research or animal studies (pre-clinical) • To answer specific health or health-related questions • That follows a study plan called a Protocol • The majority of clinical trials conducted in the U.S. test new drugs. • Source: National Medical Association

  4. Stages in the Development of Drugs Laboratory Research  Animal Studies  Clinical Trials Source: National Medical Association

  5. What is a Protocol? • Clinical trials are conducted according to a plan called a Protocol. • A Protocol is a study plan that describes, among other things: • The types of individuals that may or may not enter the study • Age, gender, the type and stage of a disease, previous treatment history, and other medical conditions • The schedule of services and procedures, drugs, dosages, and length of the study • How the outcomes of the study will be measured

  6. Why Are Clinical Trials Important? • Clinical trials are an important step in discovering new treatments for conditions and diseases • As well as new ways to detect, diagnose, and reduce the risk of disease. • Clinical trials help determine what does and does not work in people. • Many people have been helped and are alive because other people (you!) chose to participate in a trial that resulted in a new, more effective treatment.

  7. Do Many People Take Part in Clinical Trials? • Few people participate. • One 2008 study showed that less than 1% of the American population participate in clinical trials. • In addition, women, older people, minorities, disabled individuals, and rural populations have been underrepresented in clinical trials for decades. Why?

  8. Who Sponsors Clinical Trials? • Clinical trials are sponsored or funded by a variety of organizations: • Federal agencies • National Institutes of Health (NIH) • Department of Defense (DoD) • Department of Veteran’s Affairs (VA) • Pharmaceutical companies • Device companies • Foundations • A type of nonprofit corporation that may either donate funds and/or provide support to other organizations for charitable activities.

  9. What Types of Clinical Trials are There? • The NIH organizes trials into five (5) types: • Prevention • Looks for better ways to prevent disease in people who have never had the disease or prevent the disease from returning • Screening • Tests the best ways to detect certain diseases or health conditions • Diagnostic • Tests the best ways to detect certain diseases or health conditions

  10. What Types of Clinical Trials are There? • The NIH five (5) types continued: • Treatment • Tries to find better tests and procedures for diagnosing a particular disease or condition • Quality of Life • Studies options for improving the quality of life for people who have certain medical conditions

  11. What are the Phases of Clinical Trials of New Drugs? • Phase I • Researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate • safety, • determine safe dose range, and • identify side effects. • Phase II • The experimental study drug or treatment is given to a larger group of people (100-300) to see if it is • effective and to • further evaluate its safety.

  12. What are the Phases of Clinical Trials of New Drugs? • Phase III • The experimental drug or treatment is given to a large group of people (1,000-3,000) to confirm • effectiveness, • monitor side effects, • compare it to commonly used treatments, and • collect information that will allow the experimental drug or treatment to be used safely.

  13. What are the Phases of Clinical Trials of New Drugs? • Phase IV • Post marketing studies (drug has been approved by the Food and Drug Administration) that • gather additional information, including the drug’s risks, benefits, and optimal use. Source: ClinicalTrials.gov

  14. Potential Benefits of Taking Part • Opportunity to get actively involved in your health care • Potentially receive free health screenings and exams • Gain access to potentially new research treatments • Access to expert medical care for the condition being studied and close monitoring • Since investigators are often specialists in study area • Have the chance to help others and improve medical care

  15. Potential Risks of Taking Part • Unpleasant and serious side effects • Treatment may not be effective for all study subjects • Protocol may require more time and attention than standard treatment • May need to visit the study site on a regular basis • More treatments than normal • For some trials, there may be expenses not covered by the sponsor of the trial. • Possible costs are discussed during the informed consent process and documented in the informed consent form.

  16. Finding a Clinical Trial: The Next Steps

  17. Finding Clinical Trials • Your healthcare provider • Remember – your best starting point is your doctor and other members of your healthcare team • They can help you determine whether a clinical trial is a good option. • The newspaper, radio, television • Local universities, health providers, and hospitals • Examples - The University of Tennessee Health Science Center, Methodist Foundation, The Regional Medical Center at Memphis, UT Medical Group, Inc. • The Internet

  18. Using the Internet to Find A Clinical Trial • ClinicalTrials.gov • ClinicalTrials.gov is maintained by the National Library of Medicine and is a service of the National Institutes of Health. • It is a registry of federally and privately supported clinical trials conducted in the United States and around the world. • Internet address: http://clinicaltrials.gov • Will provide you with information on a trial such as: • The trial’s purpose • Who may participate • Locations • Phone numbers for more details

  19. Fill in as much or as little as you wish!

  20. Using the Internet to Find a Clinical Trial • CenterWatch • CenterWatch is a third-party clinical trial website that is not operated by funders, sponsors, or organizations carrying out clinical trials. • It offers information on clinical trials, news and analysis, study grants, and trial listings to professions and patients. • Internet address: http://www.centerwatch.com/ • Can search clinical trials by: • Medical condition • Therapeutic area

  21. Note the different pages listed by letters of the alphabet!

  22. Using the Internet to Find a Clinical Trial • Industry-Sponsored Sites • If you are aware of a treatment and know the company that manufactures it, locate the Website of the company. • Try a search engine like Google • Some of largest pharmaceutical companies: • Johnson & Johnson - http://www.jnj.com/ • Pfizer - http://www.pfizer.com/ • Roche – http://www.roche.com/ • GlaxoSmithKline - http://www.gsk.com/ • Find company’s customer service telephone number • When you call, ask to speak to the company’s clinical trial department • Tell them that you are looking for a trial that you might be eligible to join

  23. After Finding a Clinical Trial: Whether or Not to Participate

  24. Make a List of Potential Trials • Trial objective • Make sure the trial’s main objective matches your goals • Eligibility criteria • Does your diagnosis and current overall state of health match the eligibility criteria? This may tell you whether you qualify for the trial. • Trial location • Is the location of the trial manageable for you? Is parking available? Look carefully at how often you will be required to go to the trial site and decide how far and often you are willing to travel. • Study duration • Will the time commitment work for you and your family?

  25. Contact the Clinical Trial Team • Contact the team directly • Through your research, you should have the name and telephone number of someone you can contact for more information. • Ask to speak with the study coordinator • A study coordinator works under the direction of the principal investigator and is responsible for the organization and coordination of a research project. • For example - Screening, recruiting, and enrolling participants, consenting, collecting data, and scheduling • The study coordinator can answer questions about a trial. • The trial coordinator may also be responsible for determining whether you are likely eligible to join the trial.

  26. Questions To Ask • Is the trial still open? • What is the purpose of the trial? • Am I eligible for the trial? • Who is sponsoring the trial? • How long will the trial last? • What kind of tests, procedures, or treatments will be performed? • How many? • How often?

  27. Questions to Ask • What costs will I be responsible for? • Service and/or procedures • Will I be paid for childcare, travel, and other expenses? • What are the risks and benefits? • How do the risks and benefits compare to my current treatment? • Can I leave the trial at anytime? • How will participating in the trial affect my everyday life?

  28. After Finding a Clinical Trial: Final Steps

  29. Discuss and Review Options • It is helpful to talk with your doctor, family members, and/or friends before joining a trial. • Be sure to know all the various treatment options and understand possible risks and benefits • You may decide that joining a trial is your best option or you may decide not to join. It is your choice

  30. Schedule an Appointment • If you decide that the clinical trial is the best option for you, schedule an appointment with the study coordinator.

  31. Learn as Much as You Can about the Clinical Trial Before Deciding to Participate

  32. For More Information • National Institutes of Health • An agency of the Department of Health and Human Services and is the primary Federal agency for conducting and supporting medical research. • http://www.nih.gov/ • ClinicalTrials.gov can be accessed through the National Institutes of Health website • Food and Drug Administration • An agency of the Department of Health and Human Services responsible for protecting and promoting public health through the regulation and supervision of many areas, including pharmaceutical drugs and medical devices. • http://www.fda.gov/

  33. How to Find and Access Clinical Trials Alisa M. Firehock, MHA, FACHE Executive Director Tennessee Clinical Trials Network alisa.firehock@tctn.org 901-448-6977 office 901-448-1512 fax Please visit the Tennessee Clinical Trials website at: http://www.tctn.org

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