Using CluePoints to Identify protocol Deviations in Patient Selection
Every clinical trial protocol requires a set of criteria to be developed that describes the types of patients who are eligible to take part in the research, with the aim of creating a desired population from which study data can be collected.
Patients are included in a trial only when they have satisfied a set of inclusion and exclusion standards based on the research objectives of a particular study and covering factors such as age, disease stage, gender and treatment history.
These eligibility standards are put in place to ensure that new approaches are tested on similar groups of people so that it is clear to which groups a clinical trial's results apply. If the specified selection criteria are not strictly adhered to, the resulting data will be unreliable and less generalizable due to the variation in the characteristics of the selected patients
Download the case study to discover how CluePoints identified the patient selection and treatment discontinuation issues during a phase III trial in cardiovascular disease.