How do you define the importance of data quality in clinical trials? An accurate reflection of a subject’s experience during a trial? Uniformity and completeness of the data collected? Frequency of deviations? All of the above. The need to define quality standards and implement structured data collection methods is imperative in order to reduce variability in the analysis and improve outcomes of clinical trials.
Data quality and integrity are key aspects of Good Clinical Practice (GCP) and sponsors are expected by regulators to demonstrate oversight of clinical studies to ensure proper conduct, safety of study subjects and accuracy and completeness of the clinical study data.
Traditionally oversight of a clinical study has included on-site data monitoring, performed by or on behalf of the sponsors, with monitors visiting each study site at regular intervals to confirm that study procedures are being carried out according to the protocol and performing Source Data Verification (SDV), i.e. confirming that the data in the CRF accurately reflects the source notes. This is a labour-intensive and costly process. In terms of the amount of errors uncovered, is 100% SDV really worthwhile as a quality control measure?
Quality is paramount to all programming work carried out at PHASTAR to ensure accurate reporting and analysis of clinical trials. In order to maintain our high standards, we have SOPs and Work Instructions that detail our standardised internal processes for SAS programming and QC across studies and sites.
Other resources available to staff include our checklist of hints and tips collated from over 1500 years of industry experience, “The PHASTAR Discipline”; a CDISC specific checklist; and we also a run full day internal training course on delivering to quality that includes a practical workshop which is given to all new starters and offered as a refresher for experienced staff.
PHASTAR's annual SAS Art Competition closed at the end of November and it is time to reveal this year's winner!
Every year we are really impressed by the entries we receive from statisticians and SAS programmers; however, there can only be one winner...
Traditionally the focus of pharmaceutical development has been on generating evidence to satisfy regulatory authorities’ assessments of efficacy, safety, and quality. There is increasing focus on the “4th hurdle to market entry” - the assessment by payers of newly approved products. This is based on cost effectiveness – assessment of the value of the incremental benefit provided by a product. One of the challenges in this area is the considerable variation in the evidence requirements across markets. Regional variation also occurs in assessments for the registration of pharmaceuticals, but here ICH does provide harmonisation across the major markets on key principles.