Plymouth Meeting, PA – April 10, 2012: CRF Health, a world leading provider of global ePRO solutions tailored for the life sciences industry, today announced that it has received approval to use fully validated electronic versions of the Asthma Control Questionnaire (ACQ) & the standardized Asthma Quality of Life Questionnaire (AQLQ(S)) instruments on its TrialMax Touch™ Windows® handheld ePRO devices.
Originally developed by Professor Elizabeth Juniper, these two instruments are considered key outcome measures for high-quality asthma studies. The ACQ measures both the adequacy of, and any changes in, patient asthma control. Worsening asthma control is often indicative of an exacerbation of a patient’s disease, a change that is associated with negative clinical outcomes, and asthma control is a vital component of modern asthma management. The AQLQ measures the functional problems (physical, emotional, social and occupational) that are most troublesome to adults with asthma, and provides an important insight into the impact of the disease on patient’s quality of life.
Following an equivalence study, in collaboration with scientific partners Oxford Outcomes, the TrialMax Touch™ versions can be considered equivalent to the validated paper versions of the questionnaires in accordance with the guidelines published by the ISPOR ePRO Good Research Practices task force. Their report “Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-based Patient-Reported Outcome (PRO) Measures” is widely endorsed as the industry response to FDA PRO Guidance. Additionally, CRF Health met the strict targets for concordance between paper and electronic specified by Professor Juniper to ensure high-quality implementations of her instruments; namely an ICC of 0.90 for the ACQ and 0.95 for the AQLQ.
The electronic versions of the ACQ and AQLQ, now supported on Windows® Mobile devices, provide clinical trial managers more flexibility in designing trials along with the many other benefits of using ePRO, including higher compliance, higher quality data, and more efficient clinical trials. The HTC HD2 device allows for data collection over extended periods of time in a patient’s own home. Patients have consistently expressed a preference for the TrialMax Touch™ electronic diary over paper questionnaires across numerous studies. Combined with CRF Health’s wireless integration between the HTC HD2 and the handheld Vitalograph asma1 FEV1 and peak flow meter, this provides a powerful solution for data collection outside the confines of a clinical visit.
CRF Health’s Paul O’Donohoe, Manager of Health Outcomes, commented, “The extremely impressive results of this validation study demonstrate CRF Health’s expertise in creating high quality and scientifically robust electronic implementations of outcomes measures. Gaining author input is a key step in our scientific strategy, and we worked closely with Professor Juniper throughout the development process. This collaborative process helped create powerful implementations of these important asthma tools.”
Rauha Tulkki-Wilke, VP Product & Service Management continues, “With the support for the ‘gold standard’ asthma instruments on user-friendly Windows® Mobile ePRO devices combined with possibility of capturing PEF measurements electronically, CRF Health offers the most patient engaging asthma ePRO solution for clinical trials. CRF Health is registered as a manufacturer of Medical Device Data Systems ensuring compliance with regulatory requirements.”
About CRF Health
CRF Health is a global leader in eCOA (electronic Clinical Outcome Assessments) solutions for the life sciences industry. eCOA encompasses PRO (Patient Reported Outcomes), ObsRO (Observer Reported Outcomes) and ClinRO (Clinician or Rater Reported Outcomes).
Through innovative technology, a thorough understanding of drug development, and mobile computing, CRF Health is driving the change to higher quality outcomes and more efficient paper-free clinical trials.
CRF Health’s eCOA technology has been used in more than 70 countries, on six continents and 68 regional languages, including several regional Indian dialects. CRF Health consistently demonstrates the industry’s highest patient compliance rates, while delivering unrivaled data accuracy and unmatched patient and site acceptance.
Since 2000, CRF Health has continued to provide true global eCOA delivery and service. CRF Health is headquartered in the US and operates globally with an R&D center of excellence in Helsinki, Finland.
For more information, please visit www.crfhealth.com.
Heather Bilinski, Marketing Manager
4000 Chemical Road, Suite 400
Plymouth Meeting, PA 19462
Phone: +1 267.498.2349 | Fax: +1 215.565.0001