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Clinical Trials 101

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This webinar will tell you what you need to know about clinical trials, their history, and help you prepare for a trial. If you’re currently considering participating in a clinical trial, we hope that this webinar helps to answer many of your questions.

In the presentation you'll learn the difference between different types of clinical trial and the design and purpose of clinical trials, and you'll get an inside look at the approval process.

The webinar was hosted by Dawn Richards, Director of Patient and Public Engagement at Clinical Trials Ontario and featured a panel of patients, James Davidson, Eric Pitters and Kathie LaForge.

Published in: Health & Medicine
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Clinical Trials 101

  1. 1. Clinical Trials 101 & Clinical Trial Participation Webinar for the Canadian Cancer Survivor Network Dawn Richards Director, Patient & Public Engagement November 2, 2017
  2. 2. OUR VISION To make Ontario a preferred location for global clinical trials, while maintaining the highest ethical standards. OUR MISSION To strengthen, promote and capitalize on Ontario’s competitive advantages to conduct high-quality clinical trials. About Clinical Trials Ontario • Supported by the Ontario Ministry of Research, Innovation and Science • Established to address the decline in clinical trials in Ontario and leverage Ontario’s clinical research capabilities to attract more trials
  3. 3. FOCUS 2016-21: CTO strategic priorities • Advancing the Streamlined Research Ethics Review System • Streamlining Clinical Trial Agreements review and other processes • Supporting research sites for improved performance • Developing program tools and supports • Encouraging active involvement of the public • Increasing public awareness of clinical trials • Supporting healthcare providers • Industry recognition of the advantages of conducting clinical trials in Ontario and Canada • Awareness of the exceptional and world-leading clinical research conducted in the province • Engagement with the broader research community in advancing and promoting initiatives that improve the clinical trials climate in Ontario
  4. 4. The world’s first clinical trial • Recorded in the “Book of Daniel” in the Bible. • Conducted by King Nebuchadnezzar of Babylon. • Ordered his people to eat only meat and drink only wine, a diet he believed would keep them in sound physical condition. • But several young men of royal blood, who preferred to eat vegetables, objected. The king allowed these rebels to follow a diet of legumes and water —for 10 days. • When Nebuchadnezzar's experiment ended, the vegetarians appeared better nourished than the meat-eaters, so the king permitted the legume lovers to continue their diet. Source: A. Bhatt, Perspect Clin Res. 2010 Jan-Mar; 1(1): 6–10. Evolution of Clinical Research: A History Before and Beyond James Lind
  5. 5. James Lind (1716-94): First physician to conduct a clinical trial ”On the 20th of May 1747, I selected twelve patients in the scurvy, on board the Salisbury at sea. Their cases were as similar as I could have them. They all in general had putrid gums, the spots and lassitude, with weakness of the knees. They lay together in one place, being a proper apartment for the sick in the fore-hold; and had one diet common to all, viz. water gruel sweetened with sugar in the morning; fresh mutton-broth often times for dinner; at other times light puddings, boiled biscuit with sugar, etc., and for supper, barley and raisins, rice and currants, sago and wine or the like. • Two were ordered each a quart of cider a day • Two others took twenty-five drops of elixir vitriol three times a day • Two others took two spoonfuls of vinegar three times a day • Two of the worst patients were put on a course of sea-water • Two others had each two oranges and one lemon given to them every day • The two remaining patients, took an electary recommended by a hospital surgeon” Dr. James Lind's “Treatise on Scurvy” published in Edinburgh in 1753 Source: A. Bhatt, Perspect Clin Res. 2010 Jan-Mar; 1(1): 6–10. Evolution of Clinical Research: A History Before and Beyond James Lind
  6. 6. James Lind’s clinical trial “The consequence was, that the most sudden and visible good effects were perceived from the use of oranges and lemons; one of those who had taken them, being at the end of six days fit for duty … The other was the best recovered of any in his condition; and … was appointed to attend the rest of the sick. Next to the oranges, I thought the cyder had the best effects …” Dr. James Lind's “Treatise on Scurvy” published in Edinburgh in 1753 Source: A. Bhatt, Perspect Clin Res. 2010 Jan-Mar; 1(1): 6–10. Evolution of Clinical Research: A History Before and Beyond James Lind
  7. 7. Clinical trials • Research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people • Involve an intervention, i.e., test something; different from health questionnaires, chart review studies etc. • Often one of the final stages of a long and careful research process. For example, with drug development, research first takes place in a lab and then in animals • Produce the “best data available” for health care decision making • May find that a new strategy, treatment, or device improves patient outcomes; offers no benefit; or causes unexpected harm • All of these results are important because they advance medical knowledge and help improve patient care
  8. 8. Phases of clinical trials Phase 0 •Effect on the body Phase 1 •Safety, dose, side effects •Duration of weeks •Small number of participants (usually healthy) (20-80) Phase 2 •Does the treatment do what it is supposed to do? Should the dose be changed? Side effects •Duration of months •Larger number of participants (100-300) Phase 3 •How long effects last, side effects •Duration of years •Large number of participants (1000s) Phase 4 •Long term treatment effects and any side effects) •Duration of years (ongoing) •Large population
  9. 9. Clinical trials in a nutshell Approved protocol Investigator selection Approval process Participant recruitment Data entered & reviewed Data analysis Presentation & publication of results Data filed & registration obtained
  10. 10. Development of clinical trials / protocols Industry Sponsored Pharma, medical devices, biotech Focus is developing treatments that: •Improve health/well being •Provide data to have products approved for use, or expanded use Investigator Initiated Physicians & health care providers, university professors Focus is developing treatments that: •Improve health/well being •Advance science Usually grant funded, through competitive processes
  11. 11. Protocols Clinical trial protocols are usually lengthy, detailed documents that provide the information regarding why the trial is being done, who it will involve, how it will be done and how the results will be gathered, analyzed and shared. Typical parts of a clinical trial protocol: • Scientific/medical justification for the trial; may include lab/animal results, prior clinical trial results • Key measurements or “endpoints” for the trial (e.g. disease remission, survival, quality of life, side effects) • Who can and can’t be in the trial (eligibility and ineligibility criteria) • The number of participants needed for the trial (and why) • Exactly what treatments will be used and how; adjustments to treatment • Assessments – when and what, e.g. doctors visits, blood tests, questionnaires • Safety reporting • Data collected • How results will be analysed and shared • Sample consent form for participants
  12. 12. Investigator selection Investigators must be qualified to conduct the trial Industry Sponsored Trials Many are conducted in locations around the world. In selecting investigators industry may consider: • Investigator (e.g. physician) expertise – KOLs or Key Opinion Leaders • Where they can get the trial started and finished efficiently • Where potential patients may be • Where they might want to market their product Investigator Initiated Trials Multi-site trials—may access an investigator network • Cost may be an issue
  13. 13. Approval process for clinical trials Regulatory Approval • Health Canada receives and reviews clinical trial application for pharmaceuticals, biologics, medical devices and natural health products • Trials can not proceed until this approval is in place Research Ethics Approval • Protocols and information to participants must be approved by a research ethics board (REB) • REB focuses on the ‘ethical acceptability of the research’ - risks and benefits and protecting the rights of participants Institutional (hospital/university) Approval • Each institution must approve the research taking place under its auspices
  14. 14. Clinical trials in a nutshell Approved protocol Investigator selection Approval process Participant recruitment Data entered & reviewed Data analysis Presentation & publication of results Data filed & registration obtained
  15. 15. Clinical Trial Participation
  16. 16. CTO patient & public engagement • Encouraging active involvement of the public • Increasing public awareness of clinical trials • Supporting healthcare providers
  17. 17. Who CTO is aiming to help Patient Participant Public
  18. 18. Protection of participants If you have been asked to volunteer to participate in a clinical trial, there are a few things that you should know and think about when considering your decision. • Clinical trials must follow regulations and ethical standards. • Clinical trials must be reviewed and approved by a Research Ethics Board. A Research Ethics Board also provides ongoing oversight during the clinical trial. • Every clinical trial should have a protocol that explains how the clinical trial will be conducted and that has information such as potential benefits and risks, contact information, etc.. • Except for in a few unique cases, you will be asked to provide informed consent before the clinical trial starts. • Steps are taken to try to ensure confidentiality about participants. • If you decide to participate in a clinical trial and you feel it’s no longer right for you, you can stop participating at any time. You may be asked for a reason, but you do not need to provide one if you don’t wish to.
  19. 19. Things participants may wish to consider • Are you comfortable with the potential benefits and risks? Have these been explained to you in clear language that you understand? • Are you happy with and do you understand the responses to questions you have about the clinical trial? Do you know that there is a protocol for the clinical trial? Do you feel able to make an informed decision about your participation? • Are you comfortable with and trust the healthcare provider or research team you are working with? • Have you been asked to pay to participate in the clinical trial? • E.g. parking, transportation • There should not be a fee to participate in the clinical trial itself.
  20. 20. Finding a clinical trial • Talk to your healthcare provider(s). • Contact an organization that may be able to help you find a clinical trial. • Search a website such as: • www.canadiancancertrials.ca • www.health-products.canada.ca/ctdb-bdec/index-eng.jsp • www.clinicaltrials.gov. • Contact an academic research centre.
  21. 21. Contact information Website: www.ctontario.ca E-mail: dawn.richards@ctontario.ca @clinicaltrialON linkedin.com/company/clinical-trials-ontario Clinical Trials Ontario 661 University Avenue, Suite 460 MaRS Centre, West Tower Toronto, Ontario Canada M5G 1M1 Tel / 416.276.1381
  22. 22. Canadian Cancer Survivor Network 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 Telephone / Téléphone : 613-898-1871 E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca Web site www.survivornet.ca Instagram: @survivornet_ca Twitter: @survivornetca Facebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/ Canadian Cancer Survivor Network Contact Info

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