Clinical Trials Signal Detection
Recent withdrawals of approved drugs have increased regulatory attention to evaluation of a drug’s safety profile prior to approval. Many advances have been made in the mining of post-marketing adverse event data in recent years. Clinical trial data has typically not been amenable to safety data mining techniques due to small sample sizes and narrow populations. However, the depth of clinical information available from trial databases and the level of data integrity enforced by the clinical trials data collection process make these sources particularly rich in information. The promise of results from clinical trial databases is enormous, but specific analysis techniques are required to fully leverage this source. For this reason, Phase Forward's Lincoln Technologies developed the Clinical Trials Signal Detection (CTSD™) product.
CTSD™
Built upon Phase Forward’s Lincoln Technologies WebSDM electronic data submission platform, which was developed in conjunction with the FDA, the CTSD system integrates data from clinical trials into a CDISC SDTM-compliant data repository and performs automated screening for potential safety issues. This revolutionary tool provides an effective means for detecting potential safety problems early in the pre-marketing clinical trial stage. Using CTSD, biopharmaceutical companies can improve their understanding of a drug’s safety profile earlier in the development cycle.
The CTSD system offers graphical, tabular and statistical tools to assist clinical safety staff in examining, analyzing and classifying potential signals prior to drug approval. The Sector Map graph pictured below highlights adverse event terms with higher than expected counts in red for patients treated with a study drug.
Events that occur with higher than expected frequency for a comparator or placebo group appear in green, helping reviewers prioritize investigational efforts. This Sector Map groups the events into MedDRA System Organ Classes (SOCs) denoted by the rectangles outlined in white.
This viewpoint allows the analysis of associated events or syndromes in an easy-to-interpret graphical format. Users may click on the rectangles and drill down to view the patient data associated with each patient experiencing each term for more detailed analysis.
The CTSD systems includes a full range of other advanced graphical visualization tools to better understand the safety profile of products in development.