Clinical trials (FS-05)

Frontiers in clinical trials

Rob Herbert (Australia), Sallie Lamb (United Kingdom), Rebecca Craik (United States of America), Chris Maher (Australia)

Focused symposium

Saturday 2 May 2015, 08:30-10:00, Hall 404

Frontiers in clinical trials

Herbert R. 1, Lamb S. 2, Craik R. 3, Maher C. 4

1NeuRA, Sydney, Australia, 2University of Warwick, Clinical Trials Unit, Coventry, United Kingdom, 3Arcadia University, Department of Physical Therapy, Philadelphia, United States of America, 4The George Institute for Global Health, Musculoskeletal Division, Sydney, Australia

Learning objectives

  1. By the end of the symposium participants should be able to identify some of the distinguishing features the highest quality clinical trials in physiotherapy, and
  2. describe important recent developments in the conduct, analysis, dissemination and publication of randomised controlled trials in physiotherapy.

Description

The structure of the symposium will be as follows:

Introduction (Professor Chris Maher, 10 minutes).

Chris will provide a context for the symposium by briefly describing the current extent and quality of evidence from randomised controlled trials in physiotherapy. He will argue the physiotherapy profession needs to transition from having individuals or small groups conducting small scale, low quality trials to collaborative teams conducting large scale, high quality trials addressing the questions of fundamental clinical importance.

Developments in design and conduct of clinical trials (Professor Sallie Lamb, 15 minutes).

Using the examples of recently published large-scale trials in physiotherapy, Sallie will discuss:

 

  • processes for evaluation of established and novel physiotherapy interventions and for development of novel interventions, particularly complex interventions,
  • the continuum from early-phase explanatory trials to late-phase pragmatic trials, when to choose which, and how to design them,
  • common pitfalls in the design and conduct of pragmatic trials to inform health policy, commissioning and clinical practice, and
  • infrastructure requirements and teams needed to deliver high quality randomised evidence, and insights into project management for large-scale trials.

Developments in analysis of clinical trials (Professor Rob Herbert, 15 minutes).

 

Rob will briefly summarise current standards in the statistical analysis of randomised controlled trials and discuss new developments. Specifically, he will consider:

 

  • the emergence of efficient methods for analysis of trials with longitudinal data (repeated measurement of outcomes),
  • advances in methods used to minimise bias associated with missing data, especially data missing because of loss to follow-up,
  • new, rigorous approaches for generating estimates of the effect of intervention in people who comply with intervention, and in understanding the mediating role of post-randomisation covariates,
  • preliminary developments of methods for estimating between-person variability of effects of interventions, and
  • design and interpretation of randomised trials in the context of existing research evidence.

Developments in publication and dissemination of clinical trials (Professor Rebecca Craik, 15 minutes).

 

Rebecca will discuss new standards in publication and dissemination of randomised controlled trials. This will focus on:

 

  • the mandating, by most leading physiotherapy journals, of pre-trial registration of randomised trials. The history and logic of this important initiative will be explained,
  • the CONSORT guidelines for reporting of randomised trials, particularly the recent extension for pragmatic clinical trials, and
  • new possibilities for reporting of clinical trials afforded by online publication.

Discussion (30 minutes).

 

The audience will be given opportunity to comment on remarks made by the speakers, contribute additional points of view, and ask questions.

Summary (Professor Chris Maher, 5 minutes).

Chris will summarise the main points made in the presentations and the Discussion session.

Implications / Conclusions

It is hoped that the symposium will contribute to acceleration of the development of high quality clinical trials in physiotherapy.

Keywords

Clinical trials; Research methods

Funding acknowledgements

None

Relevance to WCPT and expected audience

Many of the delegates attending the WCPT congress will be physiotherapy researchers and consumers of physiotherapy research.

Target audience

Physiotherapy researchers and readers of reports of randomised trials in physiotherapy.