Clinical Research Design (CISC8011)
- 15 (0.125 EFTS)
- Provides the knowledge and skills required to conduct clinical trials ethically and safely, giving consideration to the scientific and cultural appropriateness of different clinical trial designs to optimise the contribution to advanced practice.
- Pre-requisites / Co-requisites:
- Students must be admitted to the Master of Health Science or the PGDip in Health Science or the PGCert in Health Science or the Master of Applied Practice or PGDip in Applied Practice or PGCert in Applied Practice to enrol in this course.
- Topics include:
Clinically and ethically appropriate patient recruitment and follow-up (including loss to follow up, missing data, adverse events) and the role of quality assurance external event moderation.
Different randomisation strategies and the need for appropriate control arms randomisation in clinical trials and be able to justify different approaches.
The role of blinding (single and double) and when it is not appropriate.. The CONSORT statement and how it can be used to crucially evaluate clinical trials
Presentation of data and appropriate use of different outcomes (eg, continuous, categorical, time-to-event).. The implications of non-reporting of clinical trial data and the value of clinical trials registries.
Evaluating the sample size requirements for primary end-point and implications of secondary endpoints and sub-group analysis.. The contribution of meta-analyses of randomised clinical trials to evidence.
The ethical and legal framework governing clinical trials and requirements for ethical approval and trial registration in New Zealand.
The rights of participants in clinical trials including the minimisation or harm and the requirements for informed consent.
The role of funders (ie, drug companies) in the management of trials.. Quality assurance and study documentation.
Monitoring study progress, external moderation.. Different clinical trial design - phase I (first in man), phase II/pilot and phase III designs
- Choose your class for this course from the option(s) below. You will need to attend all the sessions in that class to complete the course. Where more than one class number is shown, choose one of them and attend all sessions within that class number. (Note: If a class is held in different locations at the same time, you only need to attend all the sessions in one of the locations.)
- There are no classes on public holidays.
Class: 6408. This timetable is currently unavailable.