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QA Data rescue services: Phase IV case study
QA Data who have a large amount of experience in clinical rescue studies – taking on management of clinical trial, previously run by a different CRO or vendor on paper or in electronic data capture (EDC).
Rescue becomes necessary when an existing trial begins to run seriously behind schedule, when doubts arise over basic integrity of data or reporting systems or when relationships break down between sponsor and contractor. Quite possibly, all these problems apply simultaneously.
Conducting an effective and timely rescue requires knowledge, experience, flexibility and resources, all of which QA Data have as they are a fully functional clinical data management company with over a decade of experience with a vast array of different clients from large pharmaceutical companies to academic institutes and infant companies that are new to these types of challenges.
In short, rescue studies pose very specific challenges, as the following case study will show.
Scenario: Phase IV study in prophylaxis for chemotherapy-induced Neutropenia
QA Data was asked to take over the data management of a large Phase IV (post approval) clinical trial among patients with solid tumors receiving prophylaxis for chemotherapy-induced Neutropenia.
The neutropenic fevers and sepsis induced by chemotherapy are among the most severe complications in oncological treatment. These kill up to ten per cent of the overall cancer population, with higher fatality rates among patients with invasive fungal infections and other comorbid conditions.
Neutropenia can also require hospitalization or modification of subsequent chemotherapy doses which consequently reduced quality of life and higher treatment costs. Chemotherapy-induced neutropenia thus forms the most serious dose-limited adverse effect for most chemotherapy regimens (Lohr, 2006).
Neutropenia prevention strategies include use of colony-stimulating factors (filgrastim, pegfilgrastim and sargramostim) and using prophylactic antibiotics and antifungal medications tailored to the most likely bacterial infections.
However, use of prophylactic antibiotics remains controversial, with counter arguments including lack of survival benefit and the risk of inducing antibiotic resistance (Lo and Cullen, 2006). Therefore, there has been intense research focusing on antibiotic prophylaxis with fluoroquinolones in acute leukemia and high-dose chemotherapy patients, commencing at the same time as chemotherapy.
The Phase IV clinical trial in question formed part of this valuable research effort, involving a large international pharmaceutical company.
Although the study research had already completed, with all patient data gathered, problems began to occur at the data analysis stage. The sponsor became increasingly concerned about quality and integrity, with the existing CRO seen as unresponsive on critical details of the data cleaning process.
In September 2011, the sponsor asked QA Data to take over the data management activities on the study, with a request to have the work done in a timely fashion QA Data managed to complete this in just under eight weeks.
QA Data had to build and validate a new database, ready to input and clean the 400 CRFs involved.
This rescue project was successful because QA Data was able to follow a well-proven methodology, based on powerful tools and extensive experience. These included:
- Identifying project scope to define timelines, costs and deliverables
- Managing risks, significant way-points and defining quality measurements
- Creating liaison and contact framework
- Reviewing and redesigning eCRFs
- Creating an accurate project technical specification, including file specifications, import formats, input mechanisms, and mapping fields
- Assigning responsibilities for reviewing and validating files and processes for resolving file discrepancies
- Defining timelines for entering data and migration through to new database
- Establishing robust processes for data cleaning and validation
QA Data has significant capabilities that can be applied to rescue studies. These include strong and experienced project teams, a powerful single interface EDC system that can aggregate eCRFs, adverse events and other data within a unified database to allow accurate reporting with no additional reloading overheads.
The QA Data EDC system supports the full range of standards import formats (SAS, Excel, csv, text, XML, etc.) along with pharma industry standards such as SDTM, HL7 ECG, and CDISC. It incorporates scripting functions that can support complex edit checks and onscreen alerts, custom filters, individual form management and project overview.
Rescue study success depends on focused initial review and redesign, developing realistic timelines and liaison mechanisms to meet client expectations and, above all, ensuring and maintaining quality of data import and mapping.
In the case of this Phase IV study in prophylaxis for chemotherapy-induced Neutropenia, QA Data was able to meet all these fundamental requirements with a strong project team, highly capable systems and effective processes.
This project was successfully completed ahead of schedule with sponsor kept updated and ‘in the loop’ at every stage, resulting in glowing client feedback.
QA Data offers a rescue service for all aspects of clinical trials, ranging from problems with compliance or data integrity to providing extra resources to meet initially defined timelines. This CRO has been involved in several successful rescue studies and welcomes such briefs as providing particular opportunities to prove its capabilities and delight its clients.