Section outline

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    • Clinical Trials 

      (Click for Course Description)

      EPI 205 Winter 2021 (1.5 units).
      Course Director: Dennis Black, MA, PhD.
      Professor, Department of Epidemiology & Biostatistics
    • News forum

    • Summary of Dates for homework, protocol assignments, and all sessions (this can also be found in the syllabus)


      due dates

    • Syllabus

    • Syllabus_03.07.2021 File

    • Roster and Section Leader Contact Info

      • Andy Avins (Andy.L.Avins@kp.org)
      • Willa Brenowitz (Willa.Brenowitz@ucsf.edu)
      • Meghana Gadgil (Meghana.Gadgil@ucsf.edu)
      • Trisha Hue (Trisha.Hue@ucsf.edu)
      • Patrick Phillips (Patrick.Phillips@ucsf.edu)
      • Alice Pressman (PressmAR@sutterhealth.org)
      • Veronica Yank (Veronica.Yank@ucsf.edu)

    • Roster with section leader assignments (as of 1/9/2021) File
      Not available unless: You belong to a group in Registered Students Only

    • Protocol Assignments

    • Protocol Assignment 1 File
      Not available unless: You belong to a group in Registered Students Only
    • Protocol Assignment 2 File
      Not available unless: You belong to a group in Registered Students Only
    • Protocol Assignment 3 File
      Not available unless: You belong to a group in Registered Students Only
    • Protocol Assignment 4 File
      Not available unless: You belong to a group in Registered Students Only

    • Sample Protocols

    • Sample Protocol 1 File
    • Sample Protocol 2 File
    • Sample Protocol 3 File

  • Thursdays, January 7, 2021; 8:45 AM - 10:15 AM

    Lecture: Design, Subjects and Randomization

    Definition and importance of randomized controlled trials (RCT); examples of RCTs; disadvantages; alternatives; reasons for doing RCTs; randomization; inclusion/exclusion criteria; study designs including classical RCT, factorial designs, cross-over designs, matched pairs, cluster or grouped randomization.

    Faculty:  Dennis Black

    Location (Access restricted to registered students): Zoom URL

    • Prospectus:

    • Lecture Videos (watch prior to Thursday): 

    • Epi205 Course Logistics Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 1A Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 1A File
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 1B Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 1b File
      Not available unless: You belong to Registered Students Only
    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

    • Live Session: January 7, 2021 Media Resource
      Not available unless: You belong to Registered Students Only
    • Workshop 1 for Lecture 1 File
      Not available unless: You belong to Registered Students Only

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 10, pages 142-147 and Chapter 11, pages 151-158.

    • Abstract & Video: Schwalm, Jon-David, et al. "A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial." The Lancet 394.10205 (2019): 1231-1242. URL
      Not available unless: You belong to Registered Students Only
    • MODERNA Protocol File

      MODERNA Protocol: Scan the Moderna trial protocol summary and read the following sections within the summary:

      • Randomization
      • Inclusion & Exclusion

      Not available unless: You belong to Registered Students Only
    • Baden et al. "Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine" N Engl J Med (2020) File
      Not available unless: You belong to a group in Registered Students Only
    • Research Summary: Efficacy and Safety of mRNA-1273 SARS-CoV-2 Vaccine File
      Not available unless: You belong to a group in Registered Students Only

    • Optional Reading:

      Fundamentals of Clinical Trials (4th Edition), Chapters 4, 5, and 6.

    • Li, Bai, et al. "The CHIRPY DRAGON intervention in preventing obesity in Chinese primary-school--aged children: A cluster-randomised controlled trial." PLoS medicine 16.11 (2019). File
      Not available unless: You belong to a group in Registered Students Only
    • Manson et al., "Vitamin D supplements and prevention of cancer and cardiovascular disease" NEJM 380.1 (2019): 33-44 File
      Not available unless: You belong to a group in Registered Students Only

    • Assignment & Due Dates for this week:

              1) Research Question: Email your research question(s) to your section leader on Friday, January 8, 2021 by 5pm.

              2) Homework: Complete homework assignment #1 and submit to TAs by Monday, January 11, 2021, 5pm at UCSFClinicalTrials2021@gmail.com

              3) Protocol: Work on protocol assignment #1 and submit to your section leader by Thursday, January 21, 2021, 12pm. Please scroll above for sample protocols.

    • Homework Assignment #1 File
      Not available unless: You belong to a group in Registered Students Only
    • Biegel et al. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med 2020 File

      This article will be referred to in the homework.

      Not available unless: You belong to a group in Registered Students Only

    • Assignment Answer Key (Access restricted to registered students):

    • Answer Key for Assignment #1 File

  • Thursdays, January 14, 2021; 8:45 AM - 10:15 AM

    Lecture 2: Blinding, Intervention and Controls

    Definition and importance of blinding; strategies if the study can’t be blinded; strategies to evaluate blinding; considerations when choosing the intervention; multiple interventions; importance of the control or placebo; advantages and disadvantages of equivalence trials.

    Please watch Dr. Grady's lecture from 2020.

    Faculty: Deborah Grady

    Location (Access restricted to registered students): Zoom URL

    • Lecture Recording (watch prior to Thursday):

    • Blinding & Interventions File
      Not available unless: You belong to Registered Students Only
    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session. 
    • Q&A Session for Lecture 2 File
      Not available unless: You belong to Registered Students Only
    • 1/14/2021 Live Session Media Resource
      Not available unless: You belong to Registered Students Only

    • Session Audio/Video Recording (Access restricted to registered students):

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 10, pages 147-149.

    • Noseworthy H, et al. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial. Neurology 1994 44: 16-20. File
      Not available unless: Your ID number contains 02
    • Kirkley A, et al. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. File
      Not available unless: Your ID number contains 02

    • Optional Reading:

      Fundamentals of Clinical Trials (5th Edition), Chapter 7.

    • Assignment & Due Dates for this week:

              1) Homework: Complete homework assignment #2 and submit to TAs by Tuesday, January 19, 2021, 5pm at UCSFClinicalTrials2021@gmail.com

              2) Protocol: Work on protocol assignment #1 and submit to your section leader by Thursday, January 21, 2021, 12pm. Please scroll above for sample protocols.


    • Homework Assignment for lecture #2 File
      Not available unless: You belong to Registered Students Only

    • Assignment Answer Key (Access restricted to registered students):

    • Homework Assignment #2 - Answer Key File

  • Thursdays, January 21, 2021; 8:45 AM - 10:15 AM

    Lecture 3: Measuring Outcomes and Adverse Effects

    Clinical outcomes and alternatives. Defining adverse events; elicited vs. volunteered; nuisance adverse events; pitfalls of attribution of cause; FDA adverse events classifications.

    Faculty:  Dennis Black

    Location (Access restricted to registered students): Zoom URL


    • Session Slides:

    • Lecture 3 File
      Not available unless: You belong to Registered Students Only

    • Session Audio/Video Recording (Access restricted to registered students):

    • Lecture 3A Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 3B Media Resource
      Not available unless: You belong to Registered Students Only
    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      In this interactive, live/zoom discussion session we will focus on quandaries and controversies about efficacy and safety outcomes related to Covid-19 trials


    • Workshop Slides_01.21.2021 File
      Not available unless: You belong to Registered Students Only
    • Workshop 3 Video_01.21.2021 Media Resource
      Not available unless: You belong to Registered Students Only

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 10, pages 140-142, Chapter 11 page 162

    • Psaty BM, Lumley T. Surrogate end points and FDA approval: a tale of 2 lipid-altering drugs. JAMA. 2008 Mar 26;299(12):1474-6. File
      Not available unless: Your ID number contains 02
    • Bent S, et al. Brief communication: Better ways to question patients about adverse medical events: a randomized, controlled trial. Ann Intern Med. 2006 Feb 21;144(4):257-61. File
      Not available unless: Your ID number contains 02
    • Knoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. Epub 2020 Dec 8. PMID: 33306990. File

      Please read this article prior to Thursday's workshop

      Not available unless: You belong to Registered Students Only
    • Voysey M, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. File

      Please read this article prior to Thursday's workshop

      Not available unless: You belong to Registered Students Only

    • Homework Assignment: Exercises from Lecture 3 are due Monday, January 25, 2021 by 5pm: email to Teaching Assistants at UCSFClinicalTrials2021@gmail.com.  Bring a copy to Section.


    • Homework Assignment for Lecture 3 File
      Not available unless: You belong to Registered Students Only

    • Assignment Answer Key (Access restricted to registered students):

    • Homework Assignment for Lecture 3 - Answer Key File

  • Tuesday, January 26, 2021; 3:15 PM - 5:00 PM

    Small Group Discussion (see Roster for your section assignment)

    Faculty: 

    Location (Access restricted to registered students): Zoom URL

    Avins: Meeting ID: 867 1257 3247; Passcode: 707889
    Brenowitz: Meeting ID: 972 2251 5513; Password: 251253
    Gadgil: Meeting ID: 973 2893 4925; Password: 811427
    Hue: Meeting ID: 981 5229 9256; Password: 048118
    Phillips: Meeting ID: 912 1127 1821; Password: 984928
    Pressman:
    Yank: Meeting ID: 946 3354 1410; Password: 744119

  • Thursdays, January 28, 2021; 8:45 AM - 10:15 AM

    Lecture 4: Statistical Issues in Randomized Trials, Review of data analysis for RCTs; Factorial RCT designs and analysis approaches; Subgroups and multiple comparisons: implications for inference from RCTs. Also most informative statistical graphic techniques for RCTs. 

    Pervasiveness of multiple comparisons in randomized trials; the general problem of multiple comparisons and statistical adjustments; multiple endpoints; statistical concerns about subgroup analyses; what to do with an unexpected subgroup finding; adverse experience categorization; multivariate adjustment.

    Faculty:  Dennis Black

    Location (Access restricted to registered students): Zoom URL


    • Lecture Recording (watch prior to Thursday):

    • Lecture 4A Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 4B Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 4A File
      Not available unless: You belong to Registered Students Only
    • Lecture 4B File
      Not available unless: You belong to Registered Students Only

    • Session Audio/Video Recording (Access restricted to registered students):

    • Live Large Group Session (Access restricted to registered students): NO LIVE SESSION THIS WEEK

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 11, pages 164-166

    • Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine--reporting of subgroup analyses in clinical trials. N Engl J Med. 2007 Nov 22;357(21):2189-94. File
      Note: this paper sets the standard for evaluating RCT subgroup analyses.
      Not available unless: Your ID number contains 02
    • Polack, Fernando P., et al. "Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine." N Engl J Med (2020) File
      Not available unless: Your ID number contains 02
    • Lippman S, et al. Effect of selenium and vitamin E of risk on prostate cancer and other cancers. JAMA. 2009;301(1):(doi:10.1001/jama.2008.864) File
      Not available unless: Your ID number contains 02
    • Gaziano J, et al. Vitamins E and C in the prevention of prostate and total cancer in men: The Physicians' Health Study II randomized controlled trial. JAMA 2009;301(1):(doi:10.1001/jama.2008.862 File
      Not available unless: Your ID number contains 02
    • Manson et al. Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease. NEJM 2019 File

      Read and review the abstract

      Not available unless: Your ID number contains 02
    • Manson et al. Marine n−3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer NEJM 2019 File

      Read and review the abstract

      Not available unless: Your ID number contains 02

    • Assignment & Due Dates for this week:

      1.  Homework: Complete homework assignment for lecture #4 and submit to TAs by Monday, February 1, 2021, 5pm at UCSFClinicalTrials2021@gmail.com
      2.  Protocol: Continue working on protocol assignment #2 and submit to your section leader by Thursday, February 4, 2021; 12pm. 


    • Homework Assignment #4 File
      Not available unless: You belong to Registered Students Only
    • Lecture 4 Homework Assignment Answer Key File
      Not available unless: You belong to Registered Students Only

  • Thursdays, February 4, 2021; 8:45 AM - 10:15 AM

    Lecture 5: Follow-up, Adherence to the Protocol, and Post-Randomization and Introduction to Sample Size Planning

    Follow-up in RCTs; what happens after randomization; patient compliance or adherence; effect of incomplete follow-up; strategies to enhance compliance; intention-to- treat and per-protocol analyses; analysis based on post-randomization; subgroup analysis.

    Faculty:  Dennis Black

    Location (Access restricted to registered students): Zoom URL

    • Session Slides:

    • Session Audio/Video Recording (Access restricted to registered students):

    • Lecture 5 Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 5 File
      Not available unless: You belong to Registered Students Only
    • Lecture 5B: Sample Size Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 5B: Sample Size File
      Not available unless: You belong to Registered Students Only
    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

    • Workshop 4 - February 4, 2021 Media Resource
      Not available unless: You belong to Registered Students Only

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 6, pages 55-59 and Chapter 11, pages 160-162.

    • Hollis and Campbell. What is meant by intention to treat analysis? Survey of published randomized controlled trials. BMJ 1999:319;670-4. File
      Not available unless: Your ID number contains 02

    • Assignment and Due Dates

      1. Homework: Complete homework assignment for lecture #5 and submit to TAs by Monday, February 8, 2021, 5pm at UCSFClinicalTrials2021@gmail.com
      2. Protocol: Continue working on protocol assignment #2 and submit to your section leader by Thursday, February 4, 2021; 12pm. 


    • Homework Assignment for Lecture 5 File
      Not available unless: You belong to Registered Students Only

    • Assignment Answer Key (Access restricted to registered students):

    • Lecture 5 Homework Assignment Answer Key File
      Not available unless: You belong to Registered Students Only

  • Tuesday, February 9, 2021; 3:15 PM - 5:00 PM

    Small Group Discussion (see Roster for your section assignment)
    Review of prior lecture and problem set

    Faculty: 

    Location (Access restricted to registered students): Zoom URL


  • Thursday, February 11, 2021; 8:45am - 10:15am

    Lecture 6: Non-Inferiority Trials
    Faculty:  Vinay Prasad

    Non inferiority trials are studies that seek to show a new treatment, compared to an established treatment, is no worse than by some amount. That amount is called the margin or delta.  Equivalence trials are subset of the non-inferiority design

     



    • Lecture Recording (must watch prior to Thursday)

    • Lecture 6 - Non-Inferiority Trials Media Resource
      Not available unless: You belong to Registered Students Only
    • Lecture 6 - No-Inferiority Trials File
      Not available unless: You belong to Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      In this zoom/live session, Dr. Prasad will lead a discussion about the pitfalls of non-inferiority. Who defines the delta?  What happens if the older treatment is delivered sub-optimally?  Can a trial be non-inferior, but actually worse?  And, finally, what percentage of NI trials are non-inferior?

    • Required Reading

    • Kudo M et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet 2018 Mar 24;391(10126):1163-1173. File
      Not available unless: You belong to Registered Students Only
    • Prasad V. Non-Inferiority Trials in Medicine: Practice Changing or a Self-Fulfilling Prophecy? J Gen Intern Med 2018 Jan;33(1):3-5. doi: 10.1007/s11606-017-4191-y. File
      Not available unless: You belong to Registered Students Only

    • Assignment & Due Dates

      1. Homework: There is no homework assignment for lecture 6.
      2. Protocol: Continue working on protocol assignment #3. Due to section leaders on Thursday, February 18, 2021; 12pm.

  • Thursdays, February 18, 2021; 8:45 AM - 10:15 AM

    Lecture 7:  Nuts and Bolts  - Conducting a Trial

    Should one do a trial; pilot studies; funding sources; contracts; budgets; the study team; team management; space; recruitment of study subjects; starting the protocol; forms; compliance and follow-up; final visit and post-trial.

    Faculty:  Deborah Grady & Steven Cummings


    • Session Slides:

    • Session Audio/Video Recording (Access restricted to registered students):

    • Lecture Update: Please use Dr. Grady's 2019 lecture & slides "Nuts & Bolts"

    • Pilot Studies and Nuts&Bolts File
      Not available unless: You belong to Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      In live/Zoom session, Dr. Steven Cummings will lead an interactive session focusing on the use of new technologies to perform “Trials from home”: trials without clinical centers. This is fundamentally changing the way trials can be done.

    • NY Times Article: Clinical Trials Are Moving Out of the Lab and Into People’s Homes File
      Not available unless: You belong to Registered Students Only
    • Workshop: Dr. Cummings - Remote Trials Media Resource
      Not available unless: You belong to Registered Students Only

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 11, pages 158-159 and Chapter 17.

    • Assignments and Due Dates: 

      1. Homework: There is no homework assignment for Lecture 7.
      2. Protocol: Continue working on protocol assignment #3. Send the protocol assignment to your section leader by Thursday, February 18, 2021; 12pm.

  • Tuesday, February 23, 2021; 3:15 PM - 5:00 PM

    Small Group Discussion (see Roster for your section assignment)
    Review of prior lecture and problem set

    Faculty: 

    Location (Access restricted to registered students): Zoom URL


  • Thursdays, February 25, 2021; 8:45 AM - 10:15 AM

    Lecture 8:  Ethics in Clinical Trials and Interim Monitoring & Statistical Aspects of Interim Monitoring 

    Ethical issues in clinical trials, including choice of interventions in control and intervention groups, randomization, selection of subjects, and interim analyses

    Why alter/stop a clinical trial early; who should decide to stop the trial; what parameters should be monitored and how often; what statistical methods should be used; statistical approaches

    Faculty:  Alison Huang & Joan Hilton


    • Session Slides:

    • Trial Ethics & Interim Monitoring File
      Not available unless: You belong to Registered Students Only
    • Biostatistical Methods for Monitoring RCTs File
      Not available unless: You belong to Registered Students Only

    • Session Audio/Video Recording (Access restricted to registered students):

    • Trial Ethics & Interim Monitoring Media Resource
      Not available unless: You belong to Registered Students Only
    • Biostatistical Methods for Monitoring RCT Media Resource
      Not available unless: You belong to Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 9:45 am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      In live/Zoom session, Dr. Huang will lead an interactive session about recent clinical trials that have raised special ethical issues or involved controversial early termination.

    • Live Session: Interim Monitoring (Huang) Media Resource
      Not available unless: You belong to Registered Students Only
    • Live Session: Interim Monitoring (Huang) File
      Not available unless: You belong to Registered Students Only

    • Required Reading:

      Fundamentals of Clinical Trials (5th Edition):

      • Chapter 16 “Monitoring Committee Structure and Function” 
      • Chapter 17 “Statistical Methods Used in Interim Monitoring”

    • Lo B. Ethical issues in clinical trials, pages 1-7. File
      Not available unless: Your ID number contains 02

    • Optional Reading:

      Data monitoring in clinical trials: a practical perspective, (2nd Edition), Chapter 9 “Determining When a Data Monitoring Committee is Needed”


    • Assignments and Due Dates

      1. Homework: Homework assignment from lecture #8 is due March 1, 2021; 5pm. Email assignment to Teaching Assistants (ucsfclinicaltrials2021@gmail.com)

    • Lecture 8 Homework File
      Not available unless: You belong to Registered Students Only

    • Assignment Answer Key (Access restricted to registered students):

    • Lecture 8 Homework Assignment - Answer Key File
      Not available unless: You belong to Registered Students Only

  • Thursdays, March 4, 2021; 8:45 AM - 10:15 AM

    Lecture 9: Adaptive and Cluster Randomization Trials

    Faculty:  Joan Hilton


    • Session Slides:

    • Lecture 9 - Cluster RCT File
      Not available unless: You belong to Registered Students Only

    • Session Audio/Video Recording (Access restricted to registered students):

    • Lecture 9 - Cluster RCT Media Resource
      Not available unless: You belong to Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      In live/Zoom session, Dr. Hilton will answer questions related to statistical issues in interim monitoring and adaptive designs. 

    • Q&A Session - Cluster RCT (Hilton) Media Resource
      Not available unless: You belong to Registered Students Only

    • Required Reading:

    • Brown AW, Li P, Bohan Brown MM, Kaiser KA, Keith SW, Oakes JM, Allison DB. Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials. Am J Clin Nutr. 2015 Aug;102(2):241-8. File
      Not available unless: You belong to Registered Students Only
    • Coronado GD, Petrik AF, Vollmer WM, et al. Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial. JAMA Intern Med. 2018;178(9):1174–1181. File
      Not available unless: You belong to Registered Students Only

    • Optional Reading:

    • Covariate Balancing Strategies URL

      Optional video for viewing

      Not available unless: You belong to Registered Students Only

    • Assignments and Due Date: 

      1. NO HOMEWORK ASSIGNMENT

    • Assignment Answer Key (Access restricted to registered students):

  • Tuesday, March 9, 2021; 3:15 PM - 5:00 PM

    Small Group Discussion (see Roster for your section assignment)
    Review of prior lecture and problem set

    Faculty: 

    Location (Access restricted to registered students): Zoom URL


  • Thursday, March 11, 2021; 8:45 AM - 10:15 AM

    Lecture 10: 

    • Trials of COVID Interventions
    • Global Health Trials

    Faculty:  David Glidden & Patrick Phillips

    Dr. Glidden will discuss the issues that have presented themselves in COVID-19 therapeutic trials.

    Dr. Phillips will discuss global health trials.

     


    • Session Slides:

    • COVID Therapeutics File
      Not available unless: You belong to Registered Students Only
    • Global Health Trials File
      Not available unless: You belong to Registered Students Only

    • Session Audio/Video Recording (Access restricted to registered students):

    • Glidden: COVID Therapeutics Media Resource
      Not available unless: You belong to Registered Students Only
    • Phillips - Global Health Trials Media Resource
      Not available unless: You belong to Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Brief formal review of lecture followed by question and answer discussion. Recorded lecture should be viewed prior to this session.

      In live/Zoom session, Dr. Glidden or Dr. Phillips will present material on the COVID intervention trials or global trials.

    • Required Reading:

      Science Magazine: “WHO's treatment megatrial is at a standstill”: https://science.sciencemag.org/content/371/6533/972

      New York Times: “How the Search for Covid-19 Treatments Faltered While Vaccines Sped Ahead”: https://www.nytimes.com/2021/01/30/health/covid-drugs-antivirals.html


    • Optional Reading:

    • Assignment and Due Date: 

      1. Homework: There is no homework assignment for lecture 10.

    • Assignment Answer Key (Access restricted to registered students):

  • Thursdays, March 18, 2021; 8:45 AM - 10:15 AM

    Lecture 11: Multicenter Studies and Industry-sponsored trials
    The anatomy and physiology of multicenter trials. How to work effectively and make use of data from such trials. How industry trials operate. Pros and cons of participation in industry sponsored trials and principles that may minimize bias.

    Faculty:  Dennis Black 

    • Session Slides:

    • Multicenter Studies Pt1 File
      Not available unless: You belong to Registered Students Only
    • Multicenter Studies Pt2 File
      Not available unless: You belong to Registered Students Only

    • Session Audio/Video Recording (Access restricted to registered students):

    • Multicenter Studies PT1 Media Resource
      Not available unless: You belong to Registered Students Only
    • Multicenter Studies Pt2 Media Resource
      Not available unless: You belong to Registered Students Only

    • Live Large Group Session (Access restricted to registered students):

      There will be no live session / workshop on Thursday. Dr. Black will hold office hours on Wednesday, 3/17 from 8:30am - 9:30am. Please use the zoom link below.

    • Required Reading:

      Fundamentals of Clinical Trials (5th Edition), Chapter 21

      (Other readings may be distributed before the lecture)

    • Assignment: There is no homework assignment for Lecture 11.

    • Final Exam:

      The final exam will be posted on 3/18/2021, 10am and due on March 26, 2021, 12pm. Email final exam to Teaching Assistants (ucsfclinicaltrials2021@gmail.com). Final exams will not be accepted past the due date.

    • Final Exam 2021 File
      Not available unless: You belong to Registered Students Only