Clinical Research

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Clinical Research, presented by Steve Oh, Director, Clinical Research, Springfield Clinic.

Originally presented at Springfield Clinic Me 1st Women's Health Event, May 2010 - All information and images provided by presenter.

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Clinical Research

  1. 1. Understanding Clinical Research Steven S. Oh, Director of Research Springfield Clinic - Department of Research
  2. 2. Clinical Research is… <ul><li>A required step in the development of new medications and treatments to help control, improve and treat diseases </li></ul>
  3. 3. What’s in your medicine cabinet?
  4. 5. Clinical Research - Past <ul><li>The earliest recorded clinical trial dates back to the 605-562 BC by King Nebuchadnezzar II </li></ul><ul><ul><li>Bread and Water diet –vs- Meat and Wine diet </li></ul></ul><ul><li>The 1 st clinical trial of a “novel therapy” was in 1537 by surgeon Ambroise Parè </li></ul><ul><ul><li>Concoction of turpentine, rose oil and egg yolk prevented infections of battlefield wounds </li></ul></ul><ul><ul><li>Adapted from: Clinical Trials Centre / The History of Clinical Trials </li></ul></ul>
  5. 6. Clinical Research - Past <ul><li>The 1 st clinical trial using a control group was in 1747 by James Lind while at sea </li></ul><ul><ul><li>Citrus fruits in the diet could prevent scurvy </li></ul></ul><ul><ul><li>50 years later, the British made lemon juice a compulsory part of the seafarer's diet. </li></ul></ul>Adapted from: Clinical Trials Centre / The History of Clinical Trials
  6. 7. Clinical Research - Past <ul><li>The ethical impact of clinical trials became increasingly important in 1945 </li></ul><ul><ul><li>Led to strict regulation of medical experiments on human subjects </li></ul></ul><ul><li>The 1 st 2 trials using properly randomized treatment and control groups were conducted in 1948 & 1950 by the Medical Research Council, UK </li></ul><ul><ul><li>Adapted from: Clinical Trials Centre / The History of Clinical Trials </li></ul></ul>
  7. 8. Clinical Research - Present <ul><li>Today, because of the knowledge gained from clinical research, substantial advances have been made in the prevention, diagnosis and treatment of thousands of diseases. </li></ul><ul><ul><li>Resulted in life spans that are more than 10 years longer today. </li></ul></ul>
  8. 9. Results <ul><li>Adapted from: National Vital Statistics Report, Vol. 56, No. 9, December 28, 2007 </li></ul>
  9. 10. What does clinical research look for? In some clinical studies, a new drug or treatment is compared with the standard of care therapy Other studies may look to determine whether an existing drug or treatment could be used in a new way, to treat a different medical condition. Does it help other conditions? What are the side effects ? Is it effective ? Is it safe ? What is the best dosage? Does it work better than other SOC treatments? Does it improve a person’s quality of life? Does it improve a person’s health? Does it relieve symptoms? Clinical Research Investigational Product
  10. 11. What happens in a clinical study? <ul><li>Depends on the type of study being conducted </li></ul><ul><li>In general… </li></ul><ul><ul><li>The research team consists of physicians and their research staff (nurses, coordinators, etc) </li></ul></ul><ul><ul><li>Participants are given specific information and instructions for participating in the study </li></ul></ul><ul><ul><li>The participant and their health are monitored carefully during the clinical study </li></ul></ul><ul><ul><li>The participant is contacted after the study is completed for follow up </li></ul></ul>
  11. 12. 5 Different types of clinical research studies Clinical Research Treatment Studies Prevention Studies Diagnostic Studies Screening Studies Quality of Life Studies
  12. 13. 5 Different types of clinical research studies <ul><li>Prevention Studies </li></ul><ul><ul><li>Looks for ways to reduce the risk of getting a disease </li></ul></ul><ul><li>Screening Studies </li></ul><ul><ul><li>Looks for ways to detect certain diseases or health conditions before the symptoms occur </li></ul></ul><ul><ul><li>Adapted from: http://clinicalresearch.nih.gov/how.html </li></ul></ul>
  13. 14. 5 Different types of clinical research studies <ul><li>Diagnostic Studies </li></ul><ul><ul><li>Evaluates better tests or procedures for diagnosing a particular disease or condition in its early stages </li></ul></ul><ul><li>Treatment Studies </li></ul><ul><ul><li>Tests new treatments, new drug combinations, or new approaches to see which is the best treatment for a disease </li></ul></ul><ul><li>Quality of Life Studies </li></ul><ul><ul><li>Explores and measures ways to improve the comfort and quality of life of people with a chronic illness </li></ul></ul><ul><ul><li>Adapted from: http://clinicalresearch.nih.gov/how.html </li></ul></ul>
  14. 15. 4 Phases of Clinical Research Phase I Phase II Phase III Phase IV
  15. 16. 4 Phases of Clinical Research <ul><li>Phase I </li></ul><ul><ul><li>1 st time the investigational product / treatment is given to humans </li></ul></ul><ul><ul><li>~10-100 healthy / patient volunteers </li></ul></ul><ul><ul><li>Helps to figure out the best dosage, safety, and side effects </li></ul></ul><ul><ul><li>Adapted from: http://clinicalresearch.nih.gov/how.html </li></ul></ul>
  16. 17. 4 Phases of Clinical Research <ul><li>Phase II </li></ul><ul><ul><li>~100-300 patient volunteers / study </li></ul></ul><ul><ul><li>Very strict guidelines / criteria </li></ul></ul><ul><ul><li>Tests an investigational product with a known dose and side effects </li></ul></ul><ul><ul><ul><li>How does the body use it? </li></ul></ul></ul><ul><ul><ul><li>How does it help the condition / disease? </li></ul></ul></ul><ul><ul><li>Adapted from: http://clinicalresearch.nih.gov/how.html </li></ul></ul>
  17. 18. 4 Phases of Clinical Research <ul><li>Phase III </li></ul><ul><ul><li>~1000-3000 patient volunteers / study </li></ul></ul><ul><ul><ul><li>Continued evaluations of safety and efficacy </li></ul></ul></ul><ul><ul><li>Compared to Standard of Care treatments </li></ul></ul><ul><ul><li>Information for package insert and labeling </li></ul></ul><ul><ul><li>Adapted from: http://clinicalresearch.nih.gov/how.html </li></ul></ul>
  18. 19. 4 Phases of Clinical Research <ul><li>If the FDA approves the treatment… </li></ul>
  19. 20. 4 Phases of Clinical Research <ul><li>Phase IV </li></ul><ul><ul><li>Tracks long-term safety </li></ul></ul><ul><ul><ul><li>More information about long term safety, side effects / risks, benefits, and optimal use </li></ul></ul></ul><ul><ul><li>Larger groups of patient volunteers </li></ul></ul><ul><ul><li>Looks for drug interactions with other drugs, foods, and environment </li></ul></ul><ul><ul><li>Adapted from: http://clinicalresearch.nih.gov/how.html </li></ul></ul>
  20. 22. Who is involved? <ul><li>Physicians, pharmaceutical companies, FDA, and patient volunteers work to identify better ways for treating, preventing, diagnosing, and understanding human diseases </li></ul>
  21. 23. Pharmaceutical companies <ul><li>Pharmaceutical companies around the world work to develop new treatments, medicines, and vaccines targeted at specific diseases </li></ul>
  22. 24. Physicians and research <ul><li>Qualified physicians and their research teams are asked to assist in studying these investigational treatments by conducting clinical research at their clinics </li></ul>
  23. 25. <ul><li>Cutting Edge Research for Tomorrow’s Medicine </li></ul>
  24. 26. Springfield Clinic Department of Research <ul><li>55 Physicians / Providers currently participating in Clinical Research </li></ul><ul><li>Chief Clinical Officer </li></ul><ul><ul><li>Mary Stewart, RN, BSN </li></ul></ul><ul><li>Director of Research </li></ul><ul><ul><li>Steven Oh, BA </li></ul></ul><ul><li>Research Business Manager </li></ul><ul><ul><li>Candice Bears, BS, CCRP </li></ul></ul><ul><li>Clinical Research Manager </li></ul><ul><ul><li>Peg Carter, LPN, CCRP </li></ul></ul><ul><li>Clinical Research Coordinators </li></ul><ul><ul><li>Justin Roth, BS, CCRP </li></ul></ul><ul><ul><li>Sandi Shields, RN, OCN </li></ul></ul><ul><ul><li>Suzanne Shaffer, RN </li></ul></ul><ul><ul><li>Merri Ellen King, RN </li></ul></ul><ul><ul><li>Carlene Cowan, RN </li></ul></ul><ul><li>Clinical Recruitment Coordinator </li></ul><ul><ul><li>Jennifer Swan, BS </li></ul></ul><ul><li>Regulatory Specialist </li></ul><ul><ul><li>Marge Adams, CCRP </li></ul></ul>
  25. 27. Why do we do it? <ul><li>To provide the patients throughout the Midwest with “Cutting Edge Research for Tomorrow’s Medicine.” </li></ul><ul><li>Only through clinical studies can new treatments be evaluated, which may lead to treatments for life’s most deadly diseases. </li></ul>
  26. 28. Patient volunteers <ul><li>Patients are given the opportunity to participate in research studies by volunteering to receive investigational treatments that may not be readily available </li></ul>
  27. 29. Why participate? <ul><li>An opportunity to receive a medical research treatment that is not widely available </li></ul><ul><li>Access to quality medical care from doctors who specialize in the condition being studied </li></ul><ul><li>A chance to advance medical knowledge </li></ul><ul><li>The satisfaction of helping others who are suffering from a chronic, serious or life-threatening illness </li></ul>
  28. 30. Feedback from our patients <ul><li>We come up here </li></ul><ul><li>to one place and get </li></ul><ul><li>everything done. </li></ul><ul><li>Everyone has been </li></ul><ul><li>so helpful through </li></ul><ul><li>the whole process. </li></ul><ul><li>Wanda, Research Patient </li></ul><ul><li>They just amazed me…On my first day, the Research Department was waiting for me at the front door and personally escorted me through the entire process. That’s what it’s all about – taking care of patients. </li></ul><ul><li>Pat, Research Patient </li></ul>
  29. 31. Where do the studies come from? <ul><li>Springfield Clinic Department of Research is contacted on a weekly basis by pharmaceutical companies </li></ul><ul><ul><li>The “protocol” (study cookbook) is carefully reviewed </li></ul></ul><ul><ul><ul><li>What type of study is it? </li></ul></ul></ul><ul><ul><ul><li>Do we have the proper patient population? </li></ul></ul></ul><ul><ul><ul><li>Could our patients benefit from the study? </li></ul></ul></ul>
  30. 32. Where do the studies come from? <ul><li>If we agree to conduct the study, we must be officially chosen to participate in the study by the pharmaceutical company </li></ul><ul><li>After all of the necessary reviews and approvals have been received, the study is launched and is open for patients to participate. </li></ul><ul><ul><li>Research Committee </li></ul></ul><ul><ul><li>IRB </li></ul></ul>
  31. 33. How do we get access to it? <ul><li>Each clinical study has specific (inclusion / exclusion) criteria that determines whether a patient is eligible to participate in the study </li></ul><ul><li>Clinical Recruitment Coordinator </li></ul><ul><ul><li>Springfield Clinic Department of Research </li></ul></ul><ul><ul><li>217-582-7541 </li></ul></ul><ul><ul><ul><li>x4434 (Clinical Recruitment Coordinator) </li></ul></ul></ul><ul><ul><ul><li>X4664 (Dept. of Research Main Number) </li></ul></ul></ul>
  32. 34. If I qualify for study participation… <ul><li>Your written consent to participate will be obtained </li></ul><ul><li>You will have an assigned study coordinator who will guide you through the study </li></ul><ul><li>Access to the research team 24 hours / day, for any study related issues / concerns </li></ul><ul><li>Your progress, health, and safety will be followed by trained professional(s) throughout the study </li></ul><ul><li>You may decide to withdraw from the study at any time, without consequence to your medical care </li></ul>
  33. 35. How are Participants Protected? <ul><li>The ethical and legal codes that govern medical practice also apply to clinical research </li></ul><ul><li>Clinical trials are federally regulated with built in safeguards to protect the participants </li></ul><ul><li>Clinical trials follow carefully controlled protocols, or study plans, which detail what researchers will do throughout the study </li></ul><ul><li>Individual participant names and the personal health information of the participants will be kept confidential </li></ul><ul><li>IRBs, Data Monitoring Committees, FDA Inspections </li></ul>
  34. 36. References <ul><li>http://www.fda.gov/ </li></ul><ul><li>http://www.ich.org/ </li></ul><ul><li>http://centerwatch.com/ </li></ul><ul><li>http://www.clinicaltrials.gov </li></ul><ul><li>http://www.springfieldclinic.com/ </li></ul>
  35. 37. QUESTIONS?

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