Clinical Trials What You Need to Know


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Anyone intererested in participating in a clinical study should feel comfortable about the study and know as much as possible regarding participation in clinical research.

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Clinical Trials What You Need to Know

  1. 1. Clinical Trials – What You Need To KnowClinical Trials – What You Need To Know
  2. 2. The following will provide you withsome information about participation in clinical research.Before a medication can be used, drug companies conduct clinical trials to ensure that it is safe and effective.
  3. 3. WHAT IS A CLINICAL TRIAL?A clinical trial is aresearch study inhuman subjects underthe direct supervisionof experiencedphysicians.
  4. 4. SAFETY IS FOREMOST These trials study new treatments following strict rules set by the Food and Drug Administration (FDA). A independent group from the community called an IRB* helps protect study participants by making sure the study is compliant with the law.* Independent Review Board
  5. 5. Every medication currentlyavailable is the result of agroup of people whoparticipated in a clinicaltrial.
  6. 6. WHY PARTICIPATE?People join clinical trials for a variety ofreasons.Many people with a chronic healthcondition choose to join a clinical trial toreceive a study medication that couldpotentially improve their symptoms.
  7. 7.  Other people want the satisfaction of knowing they may ultimately help someone with a chronic or serious illness by advancing medical research today.
  8. 8.  Some people join a clinical trial to have access to no-cost health assessments. • All study-related clinic visits, physical examinations and diagnostic tests are provided to those who qualify at no charge.
  9. 9. A carefully conducted clinical trial is the fastest and safest way to find treatmentsthat lead to new and improved medicines.
  10. 10. CAN ANYBODY PARTICIPATE? All clinical trials have guidelines. These are based on things like age, gender, previous medical treatments and other conditions. Not everyone who wants to participate in a clinical trial will be accepted. Some studies need healthy volunteers, while others studies require patients with the illness or condition being studied.
  11. 11. ARE THERE RISKS? The Informed Consent Form will clearly list the known side-effects of the study medicine. Because the medications being tested are new, some side effects may still be unknown. Known risks are fully explained by the clinical trial staff. Medications being tested can have unpleasant or serious side effects.
  12. 12. WILL MY PRIVACY BE PROTECTED? All medical records and research materials that identify participants are kept confidential as required by law.
  13. 13. If accepted into a clinical trial, you can stopyour participation in the trial at any time for any reason.
  14. 14. FIND OUT MOREIf you think you are a good subject and havean interest in clinical trials, there are a manygood websites with additional information,including:•••
  15. 15. FIND OUT MORE• Visit our current enrolling studies.• Read more about participation.