May
22
Precisely how can this tool help investigators design trials to achieve practical answers to “real world” questions?
Portland, USA

Speaker: Kirsty Loudon, Andrew Cook, Adel El Feky, Heidi Gardner, Paula Lipman, Shaun Treweek

This is a workshop at the Society of Clinical Trials annual meeting, to be held 20th – 23rd May (date to be confirmed) at the Hilton Portland & Executive Tower. 921 SW Sixth Avenue, Portland, Oregon 97204, USA.

Designing clinical trials is challenging and there is a risk that trial design decisions such as the choice of outcome, eligibility criteria or comparator could render the trial irrelevant to its intended users. The PRECIS-2 tool: Designing trials that are fit for purpose was published in the BMJ 2015 and describes a tool to help clinical trial designers think more carefully about the impact their design decisions have on the applicability of the trial results. PRECIS-2 is being used by the National Institute of Health (USA) to assess proposed trial designs, is named by the National Institute of Health Research (UK) as one of eight “useful papers” for trialists and recommended by the Irish Review Board to support grant applications. The PRECIS-2 tool was developed and validated together with over 80 international trialists, clinicians, and policymakers.

This interactive workshop, which ran successfully in Liverpool at the joint SCT/ICTM conference in May 2017 will be aimed at the North American audience. We will introduce the key design domains that need to be considered to ensure that a trial is relevant to those you hope will use its results. We will then describe how the tool can facilitate decision-making and conversations among investigators and other stakeholders, and small group work will give workshops participants the opportunity for hands-on experience of applying the tool to a trial. Current projects using the PRECIS-2 tool will be used to illustrate different applications of PRECIS-2 and highlight how it can be applied to a wide range of trials. The workshop facilitators will lead an interactive discussion of how workshop participants could use the tool in their own trial design work, including how to handle challenges such as cluster designs, trials with multiple arms and considering whose perspective is important. The possible uses of the tool in future pragmatic and comparative effectiveness trial research will also be discussed.

Designing clinical trials is challenging and there is a risk that trial design decisions such as the choice of outcome, eligibility criteria or comparator could render the trial irrelevant to its intended users. The PRECIS-2 tool: Designing trials that are fit for purpose was published in the BMJ 2015 and describes a tool to help clinical trial designers think more carefully about the impact their design decisions have on the applicability of the trial results. PRECIS-2 is being used by the National Institute of Health (USA) to assess proposed trial designs, is named by the National Institute of Health Research (UK) as one of eight “useful papers” for trialists and recommended by the Irish Review Board to support grant applications. The PRECIS-2 tool was developed and validated together with over 80 international trialists, clinicians, and policymakers.

This interactive workshop, which ran successfully in Liverpool at the joint SCT/ICTM conference in May 2017 will be aimed at the North American audience. We will introduce the key design domains that need to be considered to ensure that a trial is relevant to those you hope will use its results. We will then describe how the tool can facilitate decision-making and conversations among investigators and other stakeholders, and small group work will give workshops participants the opportunity for hands-on experience of applying the tool to a trial. Current projects using the PRECIS-2 tool will be used to illustrate different applications of PRECIS-2 and highlight how it can be applied to a wide range of trials. The workshop facilitators will lead an interactive discussion of how workshop participants could use the tool in their own trial design work, including how to handle challenges such as cluster designs, trials with multiple arms and considering whose perspective is important. The possible uses of the tool in future pragmatic and comparative effectiveness trial research will also be discussed.

 

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