Covered in this presentation Basic information about clinical trials Information about finding a clinical trial Information about participating in or leaving a clinical trial Vision Mission Make Ontario a preferred location for global clinical trials while maintaining the highest ethical sta ID: 1043843
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1. The Basics about Clinical Trials
2. Covered in this presentationBasic information about clinical trialsInformation about finding a clinical trialInformation about participating in or leaving a clinical trial
3. VisionMissionMake Ontario a preferred location for global clinical trials, while maintaining the highest ethical standards.Strengthen, promote and capitalize on Ontario’s competitive advantages to conduct high-quality clinical trials.Strategic PrioritiesStreamlineStreamline processes to help make high-quality clinical trials more timely, efficient and cost-effective.EngageEngage with patients and the public to increase awareness, foster collaboration and improve how clinical trials are conducted.PromotePromote Ontario’s competitive advantages and clinical trial capacities to attract more trials and industry investment to the province.
4. Additional Informationwww.ctontario.ca/learn-about-trialsLearn About Clinical Trialswww.trial-finder.ctontario.caFind a Clinical Trial
5. The basics about clinical trials
6. A type of research involving peopleTest health-related interventions & outcomesOften answer questions like:Is the intervention safe?Does the intervention improve or cure disease, or help people live longer with disease than other treatments?Does the intervention help people feel better?What are clinical trials?
7. Treatments or interventions on their own or in combination with others. These might include:DrugsDevicesSurgeryRadiationtherapyDiagnosticproceduresDiet &lifestyleHealth interventions studied in clinical trials
8. Why are clinical trials done? To provide research data (evidence) about the intervention(s) testedHelp decide what therapies or other interventions might work best for people
9. The phases of clinical trials for drugs Phase 120 – 80 peoplePhase 2100 - 300 peoplePhase 31000+ peoplePhase 410,000+ people
10. Phase 120 – 80 peopleAlso called “first in humans”Aim to establish safety, dose and side effect informationSmall number of participantsPhase 1 clinical trials for drugs
11. Aim to establish efficacy, learn more about dose and side effect informationFor a larger number of participantsPhase 2 clinical trials for drugs Phase 2100 - 300 people
12. Aim to see how long effects last, learn more about dose and side effect informationFor a large number of participantsA randomized clinical trial is when two or more interventions or treatment arms are compared to each other.Participants are assigned by chance to one of the interventions to reduce bias.Phase 3 clinical trials for drugs Phase 31000+ people
13. Also called post-marketing surveillanceStudy long term side effectsFor a very large number of participantsPhase 410,000+ peoplePhase 4 clinical trials for drugs
14. An inactive therapy (such as a drug, natural health product, or device) that looks like an active therapyNot intended to have any effect on the condition being studiedIs used to make the results of the study more reliableUsed if there is no ‘standard of care’ for a condition or diseasePlacebo
15. Finding a Clinical Trial
16. To find a clinical trial, you may wish to: Talk to your health care providerAsk a health charity or patient organizationContact a hospital or organization that does researchFollow up on a newspaper, tv, or radio adUse CTO’s Clinical Trial Finder
17. Are all costs of the clinical trial covered (for example, the study treatments)?What are the qualifications of the clinical trial team?Has the clinical trial application been reviewed by a regulatory agency?Has the clinical trial been reviewed and approved by a research ethics board?Was the clinical trial reviewed and approved by the institution or organization where it is taking place?Questions to ask to determine if a clinical trial is reputable or credible
18. All of the costs of the clinical trial covered (for example, the study treatments)You are satisfied qualifications of the clinical trial teamThe clinical trial application been reviewed by a regulatory agencyThe clinical trial been reviewed and approved by a research ethics boardThe clinical trial reviewed and approved by the institution or organization where it is taking placeYou meet the eligibility criteria to be in the clinical trialDetermining if a clinical trial is a good clinical trial for you
19. Receiving no treatmentOPTION 1OPTION 3Talking to your doctor about potential known benefits and risks of these options (including no treatment) may be helpful Other options you may wish to considerReceiving standard treatment or a different form of treatment than what you are currently onOPTION 2Participation in a different research studyOPTION 3
20. What if you can’t find a clinical trial? If there is a clinical trial in another location that you are interested in, contact the study team (Is it possible? How will this affect you?)There may be ways to bring the clinical trial closer to youKeep up to date on research and check time to time on clinical trials
21. Can you say no if your health care provider offers a clinical trial?You can say no if you feel this clinical trial isn’t the right choice for you Your relationship with your health care provider should not change no matter what you decide about a clinical trialYes
22. Participating in or withdrawing from a clinical trial
23. If a participant withdraws consent, the participant can also request the withdrawal of their data or human biological materials.Consent is voluntarilyConsent can be withdrawn at any timeConsent is an ongoing processInformed consent
24. It is up to you to decide if the potential benefits outweigh the potential risksPotential benefits and risks will be different for each clinical trial and described in the informed consent formAsk questions about potential benefits and risks until you feel satisfied Potential benefits and risks
25. Can end your participation at any time without providing a reason Are encouraged to contact the study doctor/staff about your decision or to ask questions before you make itMay be asked questions about your experience, and to have lab tests and physical exams to safely stopMay be able to withdraw your permission to use information that was collected about youLeaving a clinical trial - withdrawal
26. Leaving a clinical trial - withdrawalwww.ctontario.ca/learn-about-trials
27. Thank you!dawn.richards@ctontario.cawww.ctontario.caCTO is supported by the Ontario Ministry of Colleges and Universities