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Introduction to Phase 2 & 3 Clinical Trials

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Introduction to Phase 2 & 3 Clinical Trials

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Webinar Series on Demystifying Phases in Clinical Trials & COVID-19 Updates organized by Institute for Clinical Research (ICR), NIH
Speaker: Dato Dr Chang Kian Meng, Haematologist from Sunway Medical Centre

More information, please visit: https://clinupcovid.mailerpage.com/resources/p9f2i7-introduction-to-phase-2-3-trial-s

Webinar Series on Demystifying Phases in Clinical Trials & COVID-19 Updates organized by Institute for Clinical Research (ICR), NIH
Speaker: Dato Dr Chang Kian Meng, Haematologist from Sunway Medical Centre

More information, please visit: https://clinupcovid.mailerpage.com/resources/p9f2i7-introduction-to-phase-2-3-trial-s

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Introduction to Phase 2 & 3 Clinical Trials

  1. 1. Introduction to Phase 2 & 3 Clinical Trials Dato’ Dr Chang Kian Meng, FRCP SREC Sunway Medical Centre
  2. 2. Disclaimer • This slide was prepared for the Webinar Series Demystifying Clinical Trials and challenges during the COVID-19 pandemic session on 28 July 2021, by Dato Dr Chang Kian Meng, Haematologist from Sunway Medical Centre • This is intended to share within healthcare professionals, not for public • Kindly acknowledge “Clinical Updates in COVID-19 http://www.nih.gov.my/covid-19” should you plan to share the information obtained from this slide with your colleagues.
  3. 3. Outline Drug Discovery and Development Phase 2 & 3 Clinical Trial Challenges related to clinical trial research during the COVID-19 pandemic
  4. 4. Stages of Drug Development To develop ONE successful medicine, it can take: •Testing of 10k drug candidates •Over a decade •Over 1 billion dollars
  5. 5. 5 Critical to the health of a population is the development of safe and effective diagnostic, therapeutic, and vaccine products, processes that depend upon clinical trials … Bierer et al. Journal of Bioethical Inquiry 2020
  6. 6. Phase 2 Clinical Trial • Study Participants: Up to several hundred patients. • Length of Study: Approx. several months to 2 years
  7. 7. Phase 2 Clinical Trial • often referred to as “therapeutic exploratory” • involve small numbers of patients with the disease of interest • primarily to test safety, pharmacodynamics and pharmacokinetics • may help to determine dose, dose frequencies, administration routes for phase III trials • these studies are not large enough to show whether the drug will be beneficial or efficacious • Drug sponsors or sponsor investigators then use these data to refine research questions, develop research methods, and design new Phase 3 research protocols.
  8. 8. Phase 2 Clinical Trial
  9. 9. Phase 3 Clinical Trial • Study Participants: 1,000 to 30,000 volunteers who have the disease or condition • Length of Study: 1 to 4 years
  10. 10. Phase 3 Clinical Trial • “therapeutic confirmatory” or pivotal trial • these studies involve a larger and more diverse target population, 1,000 to 30,000 participants. • confirm efficacy and to estimate incidence of common adverse reactions • however less common adverse reactions may need a larger population, hence Phase IV trials are needed • Vaccine trials
  11. 11. Phase 3 Clinical Trial
  12. 12. Phase 2/3 Clinical Trials in Malaysia 817 registered Phase clinical trial 2, 2/3 and 3 in clinicaltrials.gov • 496 completed • 116 recruiting Sources: www.clinicaltrials.gov
  13. 13. Phase 2/3 Clinical Trials in Malaysia • 86.8% Drugs • 8.7% Biological • 1.4% Device • 1.1% Dietary • 0.5% Procedure • 0.2% Combination • 0.1% Radiation • 1.2% Others Sources: www.clinicaltrials.gov
  14. 14. Phase 3 Clinical Trial Design • Single arm • Randomized Controlled trial • Placebo-controlled • Active-controlled • Adaptive trial
  15. 15. Phase 3 Clinical Trial Design Single arm • Less popular due to lack of controlled group • Used when therapeutic effect is expected to be very huge and obvious (ie. Hepatitis C treatment with SVR12 of above 90%) Follow up Intervention Screening Outcome Study population
  16. 16. Phase 3 Clinical Trial Design Randomized Controlled trial • Placebo-controlled • To maintain blinding, and comparison with standard of care (SOC) • Active-controlled • To compare with gold standard treatment • Randomization to ensure every patient has equal chance to receive any treatment in the study • Control biases and confounders
  17. 17. Phase 3 Clinical Trial Design Follow up Randomization Screening Outcome Study population Outcome Study drug Placebo / Active treatment / SOC Randomized Controlled Trial Design
  18. 18. Phase 3 Clinical Trial Design Adaptive trial design • Utilize the accumulated data to decide any modification in accordance with prespecified rules without affecting the trial integrity and validity • often more efficient, informative and ethical than fixed design, may make better use of resources, time and money and fewer participants
  19. 19. Phase 3 Clinical Trial Design Adaptive trial design • Types of modification may include: • Sample size changes • Early termination due to futility or efficacy endpoint achieved • Addition or removal of intervention arms • Study population eligibility criteria, new subgroup • Hypothesis (ie. superiority and non-inferiority) • Randomization ratio
  20. 20. Adaptive Trial Design Follow up New subgroup Screening Outcome Study population Outcome Study drug Placebo / Active treatment / SOC Outcome New study drug Subgroup ↑ sample size Superiority vs non-inferiority
  21. 21. Challenges to clinical research during the COVID-19 pandemic • COVID-19 first reported in Dec 2019, Wuhan, China • WHO declared COVID-19 a Public Health Emergency of International Concern Jan 30, 2020 • WHO declared pandemic on Mar 11, 2020 • As of July 1, 2021, 182 mil Covid-19 cases and 3.9 mil deaths • Global disruption to healthcare, supply chain, economy and social interaction Ethical Challenges in Clinical Research During the COVID-19 pandemic. Bierer et al. Journal of Bioethical Inquiry 2020
  22. 22. Challenges to clinical research during the COVID-19 pandemic • Shift of resources and focus on COVID-19 patient management and research • need to triage non-Covid clinical trials • trial location and resources • indication for trial • urgency for continuation • safety of participants and healthcare workers • risks to trial integrity Ethical Challenges in Clinical Research During the COVID-19 pandemic. Bierer et al. Journal of Bioethical Inquiry 2020
  23. 23. 23 Summary of clinical trials registered on ClinicalTrials.gov as of October 31,2020 Hashem et al. Frontiers in Medicine ● 2,145 interventional studies for COVID-19 covering a spectrum of potential therapeutics ● Designing research with scientific and social value is still paramount even with public pressure and demand ● Drug Repurposing ● Evidence vs Emotional based medicine ● Avoid therapeutic misconception ○ Hydroxychloroquine ○ Ivermectin
  24. 24. COVID-19 Vaccine Trial Updates 24 https://covid19.trackvaccines.org/vaccines/#phase-3
  25. 25. Vaccine candidates in Phase 3 Clinical Trial 25 https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
  26. 26. Pandemic Response to the Evolving Knowledge on Treatment for COVID-19 • Large volume of data and publications from RCT, observational cohorts, case series at rapid pace, some peer reviewed, some not yet peer-reviewed and others, press releases • The panel continuously review all data and assess scientific rigor and validity and make recommendations • Whenever possible, promising, unapproved or unlicensed Rx be studied in well-designed, controlled clinical trials incl drugs approved for other indications 26 NIH COVID-19 Treatment Guidelines
  27. 27. Pandemic Response to the Evolving Knowledge on Treatment for COVID-19 • However the panel also realize many patients and providers cannot access these potential treatment via clinical trials and need guidance • Finally, it is important to stress the recommended treatments are not mandates. The choice of what to do for an individual patient is ultimately decided by the patient and his provider 27 NIH COVID-19 Treatment Guidelines

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