CROS NT looks at the respiratory market and discusses how to efficiently conduct respiratory clinical trials to mitigate risk and reduce costs – especially in Phases II/III trials.
15% of the world’s population suffer from a respiratory disease. Asthma and chronic pulmonary disease (COPD) are the two largest indications being researched in respiratory clinical trials. These two indications are set to grow at a rate of 4.4% annually over the next 5 years given that around 300 million people suffer from some form of asthma, and COPD is one of the leading causes of death worldwide. There is also a rising demand for respiratory devices, including inhalers and nasal sprays, for the treatment of asthma. In recent years, the FDA made the development of generic inhalers a challenge, and companies are struggling to get market approval for bioequivalent generics.
Centralizing Clinical Data by Product
By centralizing data for a particular respiratory product, you can achieve a series of benefits that will lead to a much smoother and cost efficient clinical trial program. The biometrics team are able to align objectives and ensure continuity. Other benefits include uniform traceability of data, one set of biometrics SOPs, centralization of study metrics and study reports and quicker integrated summaries.
In terms of database, CRF and TFL standards, it may not be necessary to pay for design, build and table programming for CRF pages such as demography, medical history, physical examination, local laboratory, vital signs, ECG, concomitant medications, adverse events, study conclusion and patient’s VAS. Such pages will often exist already within a global library, needing only minor alteration, from a previous study.
Outsourcing to a CRO that also has the appropriate technology solutions in place can be strategic and beneficial. Being able to integrate questionnaires with an intuitive ePRO device, such as smartphones and tablets, and then being able to integrate that device with an EDC system for real time patient data collection and reporting creates operational efficiencies for respiratory clinical trials.
The respiratory clinical trials process should pair technology with proven processes. Consider using an EDC system to simplify the gathering of data coupled with an integrated system to allow the Investigator to download data from the device. CRFs developed electronically can significantly improve patient compliance, and devices such as smartphones and tablets allow patients to respond to questionnaires from home and communicate with Investigators via a wireless connection.
CROS NT and Respiratory Trials
Respiratory is a therapeutic area of expertise for CROS NT, given that we have completed over 100 studies in this area involving over 50,000 patients. The majority of our respiratory experience lies in asthma and COPD studies – both for drug and device development. CROS NT has supported several Phase III studies evaluating the treatment of COPD. Analysis involved repeatability assessments, correlation and Deming Regression.
In a recent asthma study, a large pharma company contracted CROS NT for data management and statistics services for a double blind treatment Phase IIIb study. The contract included the development of the study using EDC and the integration of data from a respiratory device, called a Spirometer, with the eCRF. The study included over 2,000 subjects (1,700 randomized using eCRF) and 196 sites across 14 European countries.
Based on CROS NT’s past experience and internal project governance between biometrics and clinical trial technology, the project was streamlined by developing the eCRF using RDC which simplified the gathering of data coupled with an integrated system to allow the Investigator to download data from the device. The implementation of the Spirometer device with Oracle Clinical to record health measures and diary data has been fully validated and used in respiratory trials.