ePRO Technology Benefits Drug Development for Pulmonary Diseases
By Christine Hall
February 26, 2014 | The quest to find new therapies to treat and cure pulmonary disease continues at a rapid pace. According to Centerwatch.com, 27,583 pulmonary studies are ongoing. Asthma studies represent more than 10% of these trials. Chronic obstructive pulmonary disease (COPD) studies make up less than 1% of ongoing studies, but it is the fourth leading cause of death worldwide.
Asthma and COPD trials depend on patient-driven data to prove efficacy, and rely heavily on patient reported outcomes (PROs) and clinical outcome assessments (COAs).
Data from dozens of studies have generated evidence that at-home use of an electronic diary (eDiary) integrated with a peak expiratory flow (PEF) spirometry meter provides a complete, contemporaneous, and accurate dataset that can be used to record and represent change in disease status and therapeutic responses.
Impact of Treating Asthma and COPD
The global asthma and COPD market is expected to reach $26.9 billion in 2017, with asthma drugs representing 57% of this market and COPD drugs constituting 43%. While the market is growing slowly due to price erosion and patent expirations of Advair, Singulair, and Symbicort, the number of ongoing trials for these indications is significant.
The number of clinical studies researching asthma outnumbers COPD 122:1. Together there are almost 11,000 asthma and COPD studies currently ongoing.
The patient population is substantial. In the US alone, it was estimated in 2011 that 25.9 million Americans have asthma, including 7.1 million children under 18. Pediatric asthma patients represent almost 30% of the US market, with asthma as one of the leading causes of school absenteeism.
As the global population ages, the burden of COPD will increase. Advances in COPD research include increased recognition of the importance of comorbid disease, identification of different COPD phenotypes, and understanding how factors other than lung function affect outcomes in patients. The challenge in the next few years will be implementation of cost-effective prevention and management strategies to stem the tide of this disease and its cost.
The respiratory market expanded considerably in the last decade, driven by the expansion of sales in existing classes and the launch of major new products with safety and convenience advantages like route of administration, once-daily administration and combinational therapies. Current competition in the asthma market is intense due to the increased entry of combinational therapies, inhaled corticosteroids and beta-agonists.
Symbicort Approved with ePRO Data
In 2007 AstraZeneca launched Symbicort in the U.S, having collected endpoint data with an ePRO System on a handheld, PHT eDiary. The approved indication was based on data from two pivotal double-blind, placebo-controlled, 12-week trials involving 1,076 patients at 45 sites in the U.S. Patients in the trials were adolescents age 12 and over, each of whom used the eDiary to complete daytime and nighttime diaries.
Patients recorded information on their PEF scores, nighttime awakenings, sputum, coughing and breathlessness in order to provide scientific researchers with insights into treatment improvements in asthma symptoms and health-related quality of life.
Unlike paper diaries, an eDiary diary provided controls on data quality, such as:
• Time response windows
• Reminder alarms
• Inherent legibility
• Completeness rules
• Programmed sequence controls
• Restricted response options while ensuring accurate timestamps
Such data quality controls are especially important for asthma trials when evaluating frequently sampled PEF scores in addition to nighttime and morning symptoms, which impact the quality of life of asthma patients.
In addition to providing trustworthy data for use in submission to the FDA, the eDiary was programmed with patient alerts and site tools to improve trial management. For example, if a patient’s PEF score decreased 20% or more from baseline over three days within a rolling seven consecutive day period, the PHT LogPad eDiary would prompt the patient to contact study personnel to discuss asthma symptoms and discontinuation. Patients reported the eDiary easy to use, and exhibited 87% compliance throughout all studies.
The studies’ success confirms the value of technologies that closer link patients to trials, and more sponsors need to rely on technology for greater efficiencies. Those vetting respiratory drugs are likely to integrate electronic clinical outcome assessment (eCOA) data with PEF meters and additional objective measures to collect submission evidence of efficacy and patient safety.
The combination will expand research and deliver novel results for clinical trials, safety studies, and personal health tracking.
Christine (Chris) Hall is Director of Marketing Programs at PHT Corporation, a company whose mobile eCOA Systems help pharmaceutical companies and CROs conduct clinical trials programs with greater confidence, ease and accuracy. She can be reached at firstname.lastname@example.org.
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