From the Guidelines
The resolution of a clinical trial is the outcome or result of the trial, which is typically measured by primary end-points such as mortality and morbidity.
Key Points
- The primary end-points in clinical trials are used to assess the intervention effects on participants, and are typically established parameters such as mortality and heart failure related morbidity [ 1 ].
- The CONSORT-Outcomes 2022 extension provides guidance on what outcome-specific information should be reported in publications of clinical trials, including 17 outcome-specific items that should be addressed in all published clinical trial reports [ 1 ].
- In clinical trials, well-defined and reliable outcome measures are crucial, and should directly measure factors that are important to patients, such as how the patient feels, functions, and survives [ 1 ].
- The choice of end points for clinical trials should be based on factors that are important to patients, and should be measured in a well-defined, standardized, and reliable way, while minimizing bias in the assessments [ 1 ].
Outcome Measures
- All-cause mortality is a commonly used outcome measure in clinical trials, and is often measured 14-21 days after randomization and initiation of study interventions [ 1 ].
- Nonfatal clinical events, such as extension of disease or protocol-defined disease, can also be used as outcome measures in clinical trials [ 1 ].
- Composite end points can be used to test multiple clinically relevant end points, either singly or in combination [ 1 ].
From the Research
Definition of Resolution in Clinical Trials
The resolution of a clinical trial refers to the outcome or conclusion of the trial. This can include:
- The determination of the efficacy and safety of a treatment or intervention
- The comparison of outcomes between different treatment groups
- The identification of any potential benefits or risks associated with the treatment or intervention
Factors Affecting Resolution
The resolution of a clinical trial can be influenced by various factors, including:
- Trial design and methodology 2
- Data collection and analysis 3
- Study protocol and organization 3
- Endpoint selection, such as overall survival (OS) or progression-free survival (PFS) 4
Importance of Resolution
The resolution of a clinical trial is crucial in informing healthcare decisions and practices. Clinicians and decision-makers rely on the results of clinical trials to: