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

    Adaptive RCTs
    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

    Adaptive RCTs
    Revision

  • Date

    6 - 31 May 2024

  • 15 Points

    CPD accreditation

  • 15 - 18 hours

    Study time

  • Fees (excl VAT)

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

  • 23 May 2024

    Contact session

Meet the Contributor

Prof Danie van Zyl

Prof Danie van Zyl

Principal Specialist Physician and Adjunct Professor;
Head of Clinical Department, Department of Internal Medicine at Kalafong Provincial Tertiary Hospital;
Lecturer in Clinical Epidemiology

Click on image for bio

Scheduled Events

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

Apr
25
Thu
8:30 am Virtual CPD – 25 April 2024
Virtual CPD – 25 April 2024
Apr 25 @ 8:30 am – 10:15 am
Virtual CPD - 25 April 2024
Programme 08h55: Login and sound check 09h00: Management Updates in Severe Eosinophilic Asthma Presented by: Prof. Guy Richards (Pulmonologist and Intensivist) 10h05: Wrap up Link to register Thank you to AstraZeneca for providing the unconditional…
May
7
Tue
8:30 am Virtual CPD – 7 May 2024
Virtual CPD – 7 May 2024
May 7 @ 8:30 am – 10:15 am
Virtual CPD - 7 May 2024
Programme 08h55: Login and sound check 09h00: TbaPresented 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 specifically…
May
8
Wed
6:30 pm Evening Virtual CPD – 8 May 2024 @ Zoom - link to register available in the invitation
Evening Virtual CPD – 8 May 2024 @ Zoom - link to register available in the invitation
May 8 @ 6:30 pm – 8:30 pm
Evening Virtual CPD - 8 May 2024 @ Zoom - link to register available in the invitation | Sandton | Gauteng | South Africa
Programme 18h55: Login and sound check 19h00: TbcPresented by: Tbc 20h05: Wrap up Link to register (Tbc) Attendance free for PTCMA members and HPCSA Medical Practitioners only – not open for Non-Members unless specifically stated.…

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