Section outline

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    • Clinical Trials 

      (Click for Course Description)

      EPI 205 Winter 2022 (2 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)

      summary of due dates

    • Syllabus

    • Roster and Section Leader Contact Info

      • Andy Avins (Andy.L.Avins@kp.org)
      • Willa Brenowitz (Willa.Brenowitz@ucsf.edu)
      • Trisha Hue (Trisha.Hue@ucsf.edu)
      • Patrick Phillips (Patrick.Phillips@ucsf.edu)
      • Vinay Prasad (Vinayak.Prasad@ucsf.edu)
      • Alice Pressman (alicecontactinfo@gmail.com)

    • EPI 205 Winter 2022 Section Assignments updated 1.14.2022 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

  • Thursday, January 6, 2022; 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
    • Epi205 2022 Course Logistics File
    • 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.

      Workshop 1:  This live/Zoom session will focus on challenges in interpretation of trial results related to participant inclusion/exclusion (topic in lecture 1) using examples from one of the Remdesivir Covid trials as well as other Covid trials.  The session will also include a brief review and time for Q&A about lecture and course logistics.

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

    • Workshop 1_Black Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • EUA Review_Pfizer File
      Not available unless: You belong to a group in Registered Students Only
    • FDA Fact Sheet_Paxlovid File
      Not available unless: You belong to a group in Registered Students Only
    • Ethics_Paxlovid File
      Not available unless: You belong to a group in Registered Students Only
    • Molnupiravir_Bernal NEJM File
      Not available unless: You belong to a group in Registered Students Only
    • Molnupiravir_Dyer BMJ File
      Not available unless: You belong to a group in Registered Students Only

    • Required Reading:

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

    • 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
    • Baden et al. “Research Summary: 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
    • 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
    • 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

      Read abstract and watch a 3 min video abstract of a cluster randomized, international study. Schwalm et al. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet, 2019 Oct 5;394(10205):1231-1242  

      Not available unless: You belong to Registered Students Only

    • Optional Reading:

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

    • 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
    • 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

    • Assignment & Due Dates for this week:

              1) Research Question: Email your research question(s) to your section leader on Friday, January 7, 2022 by 5pm.

              2) Homework: Complete homework assignment #1 and submit to TAs by Monday, January 10, 2022, 5pm at UCSFClinicalTrials2022@gmail.com

              3) Protocol: Work on protocol assignment #1 and submit to your section leader by Tuesday, January 18, 2022, 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

  • Thursday, January 13, 2022; 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.

    Faculty: Deborah Grady

    Location (Access restricted to registered students): Zoom

    • Lecture Recording (watch prior to Thursday):

    • Blinding Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Blinding File
      Not available unless: You belong to a group in Registered Students Only
    • Interventions & Controls Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Intervention & Control File
      Not available unless: You belong to a group in 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. 

      Zoom Info
      Meeting ID: 974 5907 9678
      Passcode: 013835

      https://ucsf.zoom.us/j/97459079678?pwd=T09paUFhdi91RHNLWG5uTHRrLzBmZz09


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

    • Workshop 2_01.13.2022 Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Required Reading:

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

    • Kong, et al. Effect of Electroacupuncture vs Sham Treatment on Change of Pain Severity Among Adults with Chronic Low Back Pain: A randomized clinical trial. JAMA Network Open 2020. File
      Not available unless: You belong to a group in Registered Students Only
    • 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 18, 2022, 5pm at UCSFClinicalTrials2022@gmail.com

              2) Protocol: Work on protocol assignment #1 and submit to your section leader by Thursday, January 18, 2022, 12pm. Please scroll above for sample protocols.

       

    • Homework L2 File
      Not available unless: You belong to a group in Registered Students Only

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

    • Homework Answer Key for Assignment #2 File

  • Thursday, January 20, 2022; 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 3a_2022 File
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 3b_2022 File
      Not available unless: You belong to a group in Registered Students Only

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

    • Lecture 3A_2022 Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Lecture 3b_2022 Media Resource
      Not available unless: You belong to a group in 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 3: 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 3 File
      Not available unless: You belong to a group in 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 24, 2022 by 5pm: email to Teaching Assistants at UCSFClinicalTrials2022@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 25, 2022; 3:15 PM - 5:00 PM

    Small Group Discussion (see Roster for your section assignment)

     

    Faculty: 

    Location (Access restricted to registered students): In-person at Mission Hall (550 16th Street, San Francisco) unless otherwise noted by your section leader

    Avins, Andy

    MH-2016

    Brenowitz, Willa

    MH-2108

    Hue, Trisha

    MH-2105

    Phillips, Patrick

    MH-2103

    Prasad, Vinay

    MH-2109

    Pressman, Alice

    MH-2107




  • Thursday, January 27, 2022; 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, January 31, 2022, 5pm at UCSFClinicalTrials2022@gmail.com
      2.  Protocol: Continue working on protocol assignment #2 and submit to your section leader by Monday, January 31, 2022; 12pm. 

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

  • Thursday, February 3, 2022; 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: This live interactive session will focus on case studies of follow-up and adherence challenges

    • Workshop 4 Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Workshop 4 File
      Not available unless: You belong to a group in 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 7, 2022, 5pm at UCSFClinicalTrials2022@gmail.com

    • 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

  • Tuesday, February 8, 2022; 3:15 PM - 5:00 PM

    Small Group Discussion #2 (see Roster for your section assignment)
    Review of prior lecture and problem set

    Faculty: 

    Location (Access restricted to registered students): Virtual or hybrid. Please reach out to your section leader for specific instructions.

    If hybrid: In-person at Mission Hall (550 16th Street, San Francisco) 

    Avins, Andy

    MH-2016

    Brenowitz, Willa

    MH-2108

    Hue, Trisha

    MH-2105

    Phillips, Patrick

    MH-2103

    Prasad, Vinay

    MH-2109

    Pressman, Alice

    MH-2107




  • Thursday, February 10, 2022; 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)

    • Non-Inferiority Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Non-Inferiority File
      Not available unless: You belong to a group in 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: 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?

      Zoom

      Meeting ID: 944 6342 3339
      Password: 114926
      Phone or Conference room password: 114926
      ---
      One Click Join from a PC, Mac, Linux, iOS or Android device:
      https://ucsf.zoom.us/j/94463423339?pwd=VkRrTXppMzVVQWlnSlFpdUJzZnNodz09
      ---

    • Workshop: Dr. Prasad Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • 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 Monday, February 14, 2022; 12pm.

  • Thursday, February 17, 2022; 8:45 AM - 10:15 AM

    Lecture 7:  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:

    • Ethics & Interim Monitoring (Huang) File
      Not available unless: You belong to a group in Registered Students Only
    • Statistics for Interim Monitoring File
      Not available unless: You belong to a group in Registered Students Only

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

    • Ethics and Interim Monitoring (Huang) Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Statistics for Interim Monitoring Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15 am PT.  Recorded lecture should be viewed prior to this session.

      Workshop 6: 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.

      Topic: Interactive Discussion - Clinical Trials Ethics and Interim Monitoring Cases

      Meeting ID: 967 9358 6558, Password: 135874

      https://ucsf.zoom.us/j/96793586558?pwd=M2d1WU1rcWFMLzNZaGgzTlZWZWRvdz09


    • Workshop_Huang Media Resource
      Not available unless: You belong to a group in 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 #7 is due February 24, 2022; 5pm. Email assignment to Teaching Assistants (ucsfclinicaltrials2022@gmail.com)
    • Homework_L7 (revised as of 2/16/22) File
      Not available unless: You belong to a group in Registered Students Only

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

    • Answer Key for Homework Assignment L7 File

  • Thursday, February 24, 2022; 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:

    • Nuts & Bolts File
      Not available unless: You belong to a group in Registered Students Only

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

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

    • Live Large Group Session (Access restricted to registered students): Thursday, February 24, 2022; 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.

      Meeting ID: 996 2616 8979; Password: 789440

      https://ucsf.zoom.us/j/99626168979?pwd=dFpjQ0JoTlJZb243elFZejd5eDR2QT09


    • 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 8.
      2. Protocol: Continue working on protocol assignment #4. Send the protocol assignment to your section leader by Monday, February 28, 2022; 12pm.

  • Tuesday, February 22, 2022; 3:15 PM - 5:00 PM

    Small Group Discussion #3: (see Roster for your section assignment)
    Review of prior lecture and problem set

    Faculty: 

    Location (Access restricted to registered students): Virtual or hybrid. Please reach out to your section leader for specific instructions.

    If hybrid: In-person at Mission Hall (550 16th Street, San Francisco) 

    Avins, Andy

    MH-2016

    Brenowitz, Willa

    MH-2108

    Hue, Trisha

    MH-2105

    Phillips, Patrick

    MH-2103

    Prasad, Vinay

    MH-2109

    Pressman, Alice

    MH-2107




  • Thursday, March 3, 2022; 8:45 AM - 10:15 AM

    Lecture 9: 

    Lecture 9A (Black):  Can a surrogate measurement substitute for a clinical endpoint? Don Quixote vs. the windmill (FDA). 

    Lecture 9B (Boxer): Clinical trials for Alzheimer’s disease and related dementias

    Faculty:  Dennis Black & Adam Boxer


    • Session Slides:

    • Boxer: Alzheimer's Clinical Trials File
      Not available unless: You belong to a group in Registered Students Only
    • Black: Surrogate Endpoint File
      Not available unless: You belong to a group in Registered Students Only

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

    • Boxer: Alzheimer's clinical trials Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Black: Surrogate Endpoints Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT.  Recorded lecture should be viewed prior to this session.

      Workshop: Dr. Boxer will present "The sad and lamentable story of a drug called Aduhelm: a tragedy from multiple perspectives"

      Meeting ID: 955 5325 5749; Password: 655637
      https://ucsf.zoom.us/j/95553255749?pwd=R2N0aVdsZzFONzdmQ1JBWHpmRTF5dz09&from=addon

    • Aducanumab Workshop File
      Not available unless: You belong to a group in Registered Students Only
    • Aducanumab Workshop Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Required Reading:

    • Comments for readings - README File
    • Black DM, et al. "Treatment-related changes in bone mineral density as a surrogate biomarker for fracture risk reduction: metaregression analyses of individual patient data from multiple randomised controlled trials". Lance Diab Endocrinol 2020. File
      Not available unless: You belong to a group in Registered Students Only
    • Surrogate endpoints table from FDA website File
      Not available unless: You belong to a group in Registered Students Only
    • Dunn B. "Approval of Aducanumab for Alzheimer Disease— The FDA’s Perspective". JAMA 2021 File
      Not available unless: You belong to a group in Registered Students Only

    • Optional Reading:

    • Assignments and Due Date:

      1. Homework: There is no homework assignment for this week (updated as of 2/28/22).

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

  • Tuesday, March 8, 2022; 3:15 PM - 5:00 PM

    Small Group Discussion #4 (see Roster for your section assignment)
    Review of prior lecture and problem set

    Faculty: 

    Location (Access restricted to registered students): Virtual or hybrid. Please reach out to your section leader for specific instructions.

    If hybrid: In-person at Mission Hall (550 16th Street, San Francisco) 

    Avins, Andy

    MH-2016

    Brenowitz, Willa

    MH-2108

    Hue, Trisha

    MH-2105

    Phillips, Patrick

    MH-2103

    Prasad, Vinay

    MH-2109

    Pressman, Alice

    MH-2107



  • Thursday, March 10, 2022; 8:45 AM - 10:15 AM

    Lecture 10: 

    • Trials of COVID Interventions
    • Global Health Trials

    Faculty:  David Glidden & Patrick Phillips

    Dr. Glidden will discuss challenges in Trials of Repurposed Medications for Outpatient Treatment of COVID-19

    Dr. Phillips will discuss global health trials.

     


    • Session Slides:

    • Glidden: Trials of COVID-19 Therapeutics File
      Not available unless: You belong to a group in Registered Students Only
    • Phillips_Global Health Trials File
      Not available unless: You belong to a group in Registered Students Only

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

    • Glidden: Trials of COVID-19 Therapeutics Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Phillips_Global Health Trials Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • Live Large Group Session (Access restricted to registered students): Thursday, 8:45am - 10:15am PT. 

      In person @ Mission Hall: MH-2105, and live-streamed on Zoom.

      Workshop 9: Dr. Phillips will present material on the COVID intervention trials or global trials.

    • Workshop: Dr. Phillips Global Health Trials Media Resource
      Not available unless: You belong to a group in Registered Students Only

    • 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: Homework assignment for lecture 7b due on Monday, March 14, 2022 at 5pm.

    • Interim Analysis Presentation Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Black_Short Interim Analysis File
      Not available unless: You belong to a group in Registered Students Only
    • Hernan 2008 File
      Not available unless: You belong to a group in Registered Students Only
    • Hulley et al. HERS study. JAMA 1998 File
      Not available unless: You belong to a group in Registered Students Only
    • Hulley et al. Data Monitoring in HERS File
      Not available unless: You belong to a group in Registered Students Only
    • Assignment L7b File
      Not available unless: You belong to a group in Registered Students Only

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

    • Homework Assignment L7B Answer Key File

  • Thursday, March 17, 2022; 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 Pt 1 (from 2021) File
      Not available unless: You belong to a group in Registered Students Only
    • Multicenter Studies Pt 2 (from 2021) File
      Not available unless: You belong to a group in Registered Students Only

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

    • Multicenter Studies, Pt 1 (from 2021) Media Resource
      Not available unless: You belong to a group in Registered Students Only
    • Multicenter Studies Pt 2 (from 2021) Media Resource
      Not available unless: You belong to a group in Registered Students Only

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

      Dr. Black will hold a workshop to provide a summary of multicenter/Industry collaborations and questions about final (any topic!)

    • 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 March 14, 2022, 10am and due on March 25, 2022, 12pm. Email final exam to Teaching Assistants (ucsfclinicaltrials2022@gmail.com). Final exams will not be accepted past the due date.

    • Final Exam_2022 File
      Not available unless: You belong to a group in Registered Students Only