Standardizing the design, analysis, and interpretation of patient-reported outcomes in cancer clinical trials.

12th April 2021

Patient-reported outcomes, or PROs, are important considerations when new cancer therapies are being investigated, including in benefit and risk assessments. PROs include how patients themselves experience and report their symptoms, as well as other health-related quality of life (HRQOL) issues

On 16 and 17 March, the SISAQOL-IMI consortium will convene virtually for a second consensus meeting involving all 41 members.

SISAQOL-IMI aims to generate international recommendations on how to analyse, interpret and present patient reported outcome (PRO) data collected in cancer clinical trials. A primary aim is that the recommendations generated in SISAQOL-IMI will be agreed through consensus and used by all stakeholders involved PRO data analysis to ensure consistency and improve patient-centred treatment and care. You can read more about consortium goals here.

About the consensus meeting

The SISAQOL-IMI consensus meeting will help stakeholders discuss, debate and agree the recommendations generated so far via literature reviews. These recommendations are on the following topics:

  • The design, analysis and interpretation of PRO data in cancer randomized controlled trials (RCT) – work package 2
  • The use of PRO measures for single arm trials – work package 3
  • Terminologies and definitions related to clinically meaningful change in cancer clinical trials – work package 6

During the consensus meeting, 47 recommendation “statements” will be discussed, debated and voted by a representative from each of the 41 SISAQOL-IMI stakeholder groups.

Any disagreements raised on day one will be addressed and aimed to be resolved on day two. By the end of the consensus process, it is hoped that the consortium will have a series of recommendations to take forward.

Next steps

Following the consensus meeting, the next steps will be to create a detailed technical document including the statements and how to implement them. The technical document will be supported by a layperson version that will be interpretable for patients and the general public.

Further consensus meetings are planned in the coming years to agree recommendations generated from other SISAQOL-IMI work packages.

If you have any questions about the meeting or SISAQOL-IMI please contact us.

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