August 31, 2020

NISS Meeting on Estimands and Missing Data

On September 1st, the National Institute of Statistical Science (NISS) held an online meeting to investigate topics related to methods or strategies for mitigating disruptions in trials during covid-19, as part of their Ingram Olkin Forum Series. Presenters included Suzie Cro who explored a strategy for handling unplanned disruptions in the analysis of trials using missing data methods. Other presenters included Mouna Akacha (Novartis), who discussed the value of the estimand framework (ICH 2019) in being able to support the proper analysis and interpretation of trials disrupted by covid-19, and David Murray, (Office of Disease Prevention) who provided examples from the Health Care Systems Collaboratory Project and reviewed how these trials adapted in response to various disruptions.

July 05, 2020

Recommendations to visualise treatment harm profiles in Randomised Controlled Trials – a national consensus

In collaboration with the UKCRC CTU Statistics Operation group, Rachel Phillips, Victoria Cornelius and Suzie Cro hosted three half day meetings to develop a national consensus of recommendations to display harm events in Randomised Controlled Trials. The meeting was attended by national senior statisticians from academia and industry, and delegates with info-graphic expertise.  The groups’ aim is to develop practical guidelines to support clinical trial researchers in their choice of visualisations for communicating AE data in publications. The next stage will seek input from clinicians and patients and the group will be publishing their work for trialists later this year.

June 24, 2020

A dose-finding design for early phase trials with continuous re-assessment

As part of the NIHR Statistics – Early Phase Trials Group webinar series on “Practical applications of advanced designs in Phase I Trials” Suzie Cro shared her recent experience of designing a dose finding study. The trial requires two agents to be combined where one has discrete dose levels and the other having doses that are patient specific. In the presentation Suzie Cro and Pavel Mozgunov from Lancaster University explained how they will evaluate the different discrete doses of the primary agent and allow for different ranges of the patient specific doses of the second agent.

June 11, 2020

NIHR Statistics Group Virtual Conference

As part of the 2020 NIHR Statistics Group virtual conference Rachel Phillips and Victoria Cornelius hosted a workshop on the use of visualisations to communicate information on harms in RCTs. In the workshop they demonstrated the use of four graphical displays and contrasted the visual summaries with data presented in the original published journal articles demonstrating impact for interpretation. Delegates provided feedback on the applications across settings. The responses in this session will contribute to the development of practical guidance for communicating harm data.

May 28, 2020

Evidence of unexplained discrepancies between planned and conducted statistical analyses

Different methods of analysis applied to the same clinical trial data set can lead to different conclusions. It is therefore important that the statistical analysis approach for a randomised controlled trial is pre-specified, and any changes or additions to the planned analysis should be flagged alongside trial results. This provides full transparency and allows for a thorough evaluation of the results. In a new review of trials published in high impact journals, we identified a large proportion of trials (61%) with one or more undisclosed change to the planned primary analysis approach. To see more results click the below link for the full open access publication of the review.    

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