Section outline

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  • Thursday, January 9, 2020 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:      Mission Hall 1400

    • Prospectus:

    • Session Slides:

    • Lecture 1 Slides (revised 1/9/2020) File

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

    • 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: Your ID number contains 02

    • 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: Your ID number contains 02

    • Assignment:

              1) Email your research question(s) to your section leader on Friday, January 10, 2020 by 5pm.

              2) Complete homework assignment #1 and submit to TAs by Monday, January 13, 2020, 5pm at UCSFClinicalTrials2020@gmail.com

              3) Work on protocol assignment #1 and submit to your section leader by Tuesday, January 21, 2020, 12pm. Please scroll down to section 1 (January 23, 2020) for sample protocols.

    • Homework Assignment for Lecture 1 File
    • Protocol Assignment #1 File

    • Assignment Due Date: 

      Friday, 1/10/2020: Research Question due to Section Leaders

      Monday, 1/13/2020, 5pm: Lecture 1 Homework Assignment due to TAs. Email homework to Teaching Assistants at UCSFClinicalTrials2020@gmail.com

      Tuesday, 1/21/2020, 12pm: Protocol Assignment #1 due to section leaders. Email protocol assignments to Section Leaders.


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

  • Thursday, January 16, 2020; 8:45 AM – 10:15 AM

    Lecture: 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:  Mission Hall 1400

    • Session Slides:

    • Blind + Inter 2020 File

    • 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 (4th Edition), Chapter 7.

    • Assignment:

    • Lecture 2 Homework Assignment File
      Not available unless: Your ID number contains 02

    • Assignment Due Date: 

      Homework for lecture 2 is due on Tuesday, January 21, 2020 at 5pm. Please email to TAs at UCSFClinicalTrials2020@gmail.com

      Email your protocol assignment #1 to your Section Leader by 12pm (noon) on Tuesday , January 21, 2020; bring a copy to Section I.

      Protocol assignment due for Section I:
      Draft the following sections of a protocol for a randomized trial to address your own research question (2 pages max).
      1. Research question(s)
      2. Type of randomized trial design
      3. Subjects (target and accessible populations) and inclusion/exclusion criteria.
      4. Outcome measures

      You may summarize, but do not copy from other protocols.

            

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

  • Thursday, January 23, 2020; 8:45 AM – 10:15 AM

    Small Group Discussion Section

    Faculty:  Andy Avins, Willa Brenowitz, Trisha Hue, Patrick Phillips, Alice Pressman, 

    Location:  Avins MH-1105, Brenowitz MH-1106, Hue MH-1107, Phillips MH-2106, Pressman MH-1109

    • Sample Protocols

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

    • Notes & Assignment:

      Please bring the following to section #1:

      1) Protocol assignment #1 (emailed to your section leader by January 21, 2020)

      2) Lecture 1 & 2 homework for review

      Assignment: Work on protocol assignment #2

    • Assignment Due Date:  Protocol assignment #2 due to section leaders by February 17, 2020 @ 12pm (noon)

    • Protocol Assignment #2 File
      Not available unless: Your ID number contains 02

  • Thursday, January 30, 2020; 8:45 AM – 10:15 AM

    Lecture: 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 RCT

    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:  Mission Hall 1400

    • Session Slides:

    • stat issues L3 2020 db 1-29 File

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

    • 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
      Not available unless: Your ID number contains 02

    • Please read/review the abstracts from the following 2 papers. For this lecture, review how statistical issues for multiple treatments, multiple outcomes and subgroups were handled.

    • 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
      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
      Not available unless: Your ID number contains 02

    • Optional Reading:

      Fundamentals of Clinical Trials (4th Edition), Chapter 17

    • Assignment: Lecture 3 homework assignment is due on Monday, February 3, 2020 at 5pm. Email homework assignment to TAs: UCSFClinicalTrials2020@gmail.com

    • AssignL3_2020 File
      Not available unless: Your ID number contains 02

  • Thursday, February 6, 2020; 8:45 AM – 10:15 AM

    Lecture: 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:  Mission Hall 1400

    • Session Slides:

    • outcomes and events 2020 2-5 vers (1) File

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

    • 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

    • Homework Assignment: Exercises from Lecture 4 are due Monday, February 10, 2020 by 5pm: email to Teaching Assistants at UCSFClinicalTrials2020@gmail.com.  Bring a copy to Section II.

      Protocol Assignment due for Section II: Email your cumulative protocol to your Section Leader by 12pm (noon) on Monday, February 17, 2020; bring a copy to Section II.

      Continue to revise the protocol sections developed for Section I. Please see protocol assignment #2 for instructions.

    • Assign L4_2020 File
      Not available unless: Your ID number contains 02

    • Assignment Due Date:  

      Protocol assignment #2 is due Tuesday, February 18, 2020 by 12pm; email to Section Leader.

      Homework exercises from Lecture 4 are due Monday, February 10, 2020 by 5pm; email to Teaching Assistants at UCSFClinicalTrials2020@gmail.com.

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

  • Thursday, February 13, 2020; 8:45 AM – 10:15 AM

    Lecture: 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:      Mission Hall 1400

    • Session Slides:

    • Follow up and adherence 2-12-20 FINAL File

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

    • 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:

      Exercises from Lecture 5 are due February 18, 2020 by 5pm; email to Teaching Assistants at UCSFClinicalTrials2020@gmail.com

    • Assign L5_2020 File
      Not available unless: Your ID number contains 02

    • Assignment Due Date:  February 18, 2020 by 5pm

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

  • Thursday, February 20, 2020; 8:45 AM – 10:15 AM

    Small Group Discussion Section

    Faculty:  Andy Avins, Willa Brenowitz, Trisha Hue, Patrick Phillips, Alice Pressman, 

    Location:  Avins MH-1105, Brenowitz MH-1106, Hue MH-1107, Phillips MH-2106, Pressman MH-2107

    • Section reminders: Email your cumulative protocol to your section leader by 12pm (noon) on Tuesday, February 18, 2020; bring a copy to section.

      Bring your Lecture 3-5 homework for review.

    • Assignment: Work on protocol assignment #3.

    • Protocol Assignment #3 File
      Not available unless: Your ID number contains 02

    • Protocol Assignment Due Date: Email your cumulative protocol assignment to your section leader by 12pm (noon) on March 16, 2020. Bring a copy to section #3.

  • Thursday, February 27, 2020; 8:45 AM – 10:15 AM

    Lecture: 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 

    Location:      Mission Hall 1400

    • Session Slides:

    • Multictr-Industry 2020 FINAL File

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

    • Required Reading:

      Fundamentals of Clinical Trials (4th Edition), Chapter 8, pages 159-161.

      (Other readings may be distributed before the lecture)

    • Assignment: There is no homework assignment for Lecture 6.

  • Thursday, March 5, 2020; 8:45 AM – 10:15 AM

    Lecture:  Ethics in Clinical Trials and 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

    Location:     Mission Hall 1400

    • Session Slides:

    • Trial Ethics and Interim Monitoring 2020 for slides File

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

    • Required Reading:

      Designing Clinical Research (4th Edition), Chapter 11, pages 163-164 and 168-169.

    • Lo B. Ethical issues in clinical trials, pages 1-7. File
      Not available unless: Your ID number contains 02
    • Dixon D, Freedman R et al.. Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees. Clinical Trials 2006. Nov 3: 314-19. File
      Not available unless: Your ID number contains 02
    • Bryant J and Wolmark N. Letrozole after tamoxifen for breast cancer--what is the price of success? N Engl J Med. 2003 Nov 6;349(19):1855-7. File
      Not available unless: Your ID number contains 02

    • Optional Reading:

    • DeMets DL, Pocock SJ, Julian DG. The agonizing negative trend in monitoring of clinical trials. Lancet 1999:354:1983-88. File
      Not available unless: Your ID number contains 02

    • Homework Assignment: Exercises from Lecture 7 are due March 9, 2020 by 5pm; email to Teaching Assistants at UCSFClinicalTrials2020@gmail.com

      Protocol Assignment: Email your cumulative protocol to your section leader by 12pm (noon) on March 16, 2020; bring a copy to section #3.

      Assignment due for Section III:

      Continue to develop and finalize sections of your protocol started in prior sections. Draft the following sections stated in protocol assignment #3

    • AssignL7_2020 File
      Not available unless: Your ID number contains 02
    • Sample Protocol 1 File
    • Sample Protocol 2 File
    • Sample Protocol 3 File

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

  • Thursday, March 12, 2020; 8:45 AM – 10:15 AM

    Lecture:  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

    • Lecture Update: Please use Dr. Grady's 2019 lecture & slides "Nuts & Bolts" for 2020.  A zoom meeting will not be held.

    • Session Slides:

    • Pilot Studies and N+B 2019 File

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

    • Required Reading:

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

    • Assignment: There is no homework assignment for Lecture 8.

    • Final Exam: Take Home Final Exam to be posted on course website on March 12, 2020; and is due by 10am on Friday, March 20, 2020. Email to Teaching Assistants at UCSFClinicalTrials2020@gmail.com

    • Epi205 Final Exam_2020 File

  • Thursday, March 19, 2020; 8:45 AM – 10:15 AM

    Small Group Discussion Section

    Faculty:  Andy Avins, Willa Brenowitz, Trisha Hue, Patrick Phillips, Alice Pressman, 

    Location:  Sections will be held by Zoom. on 3/19 @ 8:45am - 10:15am Please connect with your section leader for zoom details.

    • Final Exam: 

      Take Home Final Exam to be posted on course website on March 12, 2020; and is due by 10am on Friday, March 20, 2020. Email to Teaching Assistants at UCSFClinicalTrials2020@gmail.com

    • Final Exam Due Date:  Friday, March 20, 2020, 10am.