Recommendations for trials in MRM specifically are contained in the second edition of the IHS guidelines.
Therefore, we propose a practical risk-based framework and recommendations for trials driven by imaging biomarkers, which allow identification of risks at trial initiation to better allocate resources and prioritise key tasks.
The inclusion of such patient centric outcomes was one of the recommendations for trials of non-pharmacological management of common musculoskeletal problems 136 and should be considered in further developing the outcome measures for tendinopathy.
For researchers designing clinical trials, we recommend using the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) 2013 statement, 12 which provides a guide for preparing clinical trial protocols.
The authors suggest the following recommendations for clinical trial involving neurostimulation devices in headache treatment: 1) Trials investigating invasive neurostimulator devices should only involve patients who are considered chronic, following the current IHS definition[38].
If confirmed by further investigation, the results may warrant adoption of relevant recommendations for controlled trial design in psychopharmacology research.
This paper provides recommendations for optimal trial design, conduct and analysis in situations where PFS has the potential to be an acceptable end-point for regulatory approval.
Our primary interest was to gather data on OS, based on previously published recommendations for clinical trial end points dealing with HCC (Llovet et al, 2008).
While there are many definitions of remission, such as that by the American College of Rheumatology (ACR) or based on composite disease activity measures 14 48 49 and all of them are contained in the EULAR/ACR recommendations for clinical trial reporting, 50 51 it is well established that some criteria allow for more residual disease activity than others.
Drawing on data-driven presentations from several focused meetings, this paper synthesizes lessons from past microbicide trials and provides recommendations for future trials of microbicide and other HIV prevention technologies.
