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HTA101: Intervention Research and Clinical Trials

presented by Prof Danie van Zyl

HTA101 Course Summary

Intervention research is research undertaken to develop new or improved healthcare interventions and to evaluate the effectiveness of pharmacologic interventions. This is considered to be the most reliable evidence in healthcare research. In a clinical trial setting, the researcher aims to explore whether a medical strategy, a treatment or a device is safe and effective for humans. Clinical trials produce the best data available for healthcare decision making by utilising stringent scientific standards and protocols in the design and development of intervention research.

Learning Outcomes

In this module you will be able to develop tools to evaluate the most current medical research findings, use the skills developed to apply specific research findings to your own setting or patient population by calculating and interpreting the results.

  • Understand the crucial issues regarding validity requirements for designing and developing protocols for intervention research as well as deciding on the appropriate outcome measures and their interpretation. This includes the following:
    • Understanding RCT (randomised controlled trials) and other trial design and clinical endpoints,
    • Validity issues: Randomisation, allocation concealment, blinding and completeness of follow-up
    • Clinical trial result interpretation: Risk, Rate, Relative Risk Reduction, Absolute Risk Reduction, NNT and NNH, p-values, Confidence Interval (CI) and power
    • Superiority, Non-inferiority, Equivalence and Bioequivalence studies
    • Adaptive clinical trials

There will be assignments to complete which will assist in competence evaluation.

Enrolment open

Programme

  • Study Unit 1

    Why RCT (Randomised Controlled Trials)
    Phases of clinical trials
    Good Clinical Practice (GCP)

  • Study Unit 3

    Endpoints
    Validity issues

  • Study Unit 5

    Power
    Subgroup analysis (Multiplicity)
    Interim analysis and stopping rules

  • Study Unit 2

    Erroneous results
    Types of RCT designs
     

  • Study Unit 4

    Interpreting RCT results
    NNT's

  • Study Unit 6

    Revision

  • Study Unit 1

    Why RCT (Randomised Controlled Trials)
    Phases of clinical trials
    Good Clinical Practice (GCP)

  • Study Unit 2

    Erroneous results
    Types of RCT designs

  • Study Unit 3

    Endpoints
    Validity issues

  • Study Unit 4

    Interpreting RCT results
    NNT's

  • Study Unit 5

    Power
    Subgroup analysis (Multiplicity)
    Interim analysis and stopping rules

  • Study Unit 6

    Revision

  • Date

    5 - 30 June 2023

  • 15 Points

    CPD accreditation

  • 15 - 18 hours

    Study time

  • Fees (excl VAT)

    R3856 Corp Members
    R4097 Stand Members
    R4338 Ind Members
    R4820 Non Members

  • 22 June 2023

    Contact session

Meet the Contributor

Prof Danie van Zyl

Prof Danie van Zyl

Head of the Department of Internal Medicine in the Faculty of Health Sciences at the University of Pretoria

Click on image for bio

Scheduled Events

Please note that dates, topics and presenters are subject to change.

Oct
3
Tue
6:30 pm Evening Virtual CPD – 3 October ... @ Zoom - link to register available in the invitation
Evening Virtual CPD – 3 October ... @ Zoom - link to register available in the invitation
Oct 3 @ 6:30 pm – 8:30 pm
Evening Virtual CPD - 3 October 2023 @ Zoom - link to register available in the invitation | Sandton | Gauteng | South Africa
Programme 18h55: Login and sound check 19h00: Tba Presented by: Tba (Tba) 20h05: Wrap up Link to register (Tbc) Attendance free for PTCMA members and HPCSA Medical Practitioners only – not open for Non-Members unless…
Oct
6
Fri
8:30 am Virtual CPD – 6 October 2023
Virtual CPD – 6 October 2023
Oct 6 @ 8:30 am – 10:15 am
Virtual CPD - 6 October 2023
Programme 08h55: Login and sound check 09h00: Tba Presented by: Tba (Tba) 10h05: Wrap up Link to register (Tbc) Attendance free for PTCMA members and HPCSA Medical Practitioners only – not open for Non-Members unless…
Oct
11
Wed
8:30 am Virtual CPD – 11 October 2023
Virtual CPD – 11 October 2023
Oct 11 @ 8:30 am – 10:15 am
Virtual CPD - 11 October 2023
Programme 08h55: Login and sound check 09h00: Tba Presented by: Tba (Tba) 10h05: Wrap up Link to register (Tbc) Attendance free for PTCMA members and HPCSA Medical Practitioners only – not open for Non-Members unless…

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