Not only are positive results essential for a study’s success, but the quality of data is just as vital. In the case of oncology clinical trials, an even greater level of intricacy is present with respect to data collection and cleaning. Precision Oncology understands the importance of compiling and reporting quality data, and also possesses the expertise to traverse the complexity of an oncology trial, this is an absolute must for the success of your study.
To optimize the end interpretability of the data, it is critical to ensure the key aspects of the protocol requirements have proper adherence at the site level. To ensure this is done consistently throughout a trial, Precision Oncology applies the use of Study Quality Metrics as a management tool to identify possible adherence issues at the site level in real-time. These metrics objectively assess the adherence at the site level to key protocol aspects including:
• Proper dose and dose modifications
• Completeness and correctness of data entry
• Adherence to tumor assessments per protocol including schedule (timing of when performed) and completeness
• Toxicity reporting above and below the mean at the site level
Study Quality Metrics reports (SQM) are an important part of global project management. We have had our SQM reports reviewed as part of the FDA review process and they have been key factors in demonstrating our “due diligence” for protocol adherence and how trial oversight was maintained throughout the trial.