Wednesday, October 3, 2012

Guest Post: CLEAR Study Update: A look inside the collaboration between ERT and UCLA

Today's guest post is from the ERT Blog.  ERT is a sponsor of the Partnerships in Clinical Trials Event taking place April 22-24, 2013 in Orlando, Florida.

CLEAR Study Update: A look inside the collaboration between ERT and UCLA

Written by: Michael Taylor – Senior Director, Healthcare Solutions

As some of you may remember, back in February 2012, ERT collaborated with the University of California, Los Angeles (UCLA) to launch the CLEAR study, an innovative program aimed at helping patients suffering from Chronic Obstructive Pulmonary Disease (COPD). You can read the press release.

For the first time in the industry, UCLA and ERT worked together to design a study that would enable home-based spirometry. If the trial is successful, it will represent a major step forward for the treatment management and continued care of COPD. It is hoped that if the methods used within this study demonstrate better, more reproducible data that indicate more specificity or sensitivity to predict exacerbations, it could change the future of clinical trials. The on-going study has already made significant progress in the first six months, something which couldn’t have been achieved without the combined expertise, knowledge and support of ERT and the UCLA teams. The broad range of skills and experience within the partnership has ensured that the methodology for the study is completely focused on improving the lives of individuals living with COPD.

ERT’s wide understanding of how to efficiently record data in clinical trials was the basis on which the study was built. Prior to meeting with the UCLA team, ERT had already developed a series of hypotheses for the trial and prepared an initial protocol covering the objectives to be achieved, the type of equipment that would be used and the specific aims of the program. Dr. Christopher Cooper, MD, Professor of Medicine and Physiology at the David Geffen School of Medicine at UCLA, took ERT’s protocol and applied his many years of experience to expand the hypotheses, getting to the very core of ERT’s objectives. Together, the two parties went on to co-develop an extensive protocol comprising primary and secondary outcomes, the entire study design, baseline assessments and specifications about how the study would work based upon the patients that it would be monitoring (view press release for more information). Once the study protocol was finalized, ERT implemented methods and criteria within its instruments that were specifically adapted for the study and trained UCLA’s team on how to efficiently and effectively record optimized data. This involved ensuring they knew how to use the devices, how to train patients to effectively use electronic PRO devices, and how to analyze the data reported on the online portal. This helped to expand UCLA’s knowledge of how technology can improve the quality of patient data in studies, demonstrating the mutual benefits of partnerships between manufacturers and academia.

The first of the study’s 200 patients were recruited in February 2012 with trial results to be reported in late 2013. Upon enrollment, each patient was provided with a full physical examination and an exit consultation planned for when the study is concluded. To date, the study has been developed to address the needs of physicians with the aim of achieving better treatment for patients living with COPD. The data being collated in the study is wide-ranging, to ascertain exactly which treatments and therapies are most effective. Due to the large population used within the study, there has been a large volume of interest generated about the program across the industry. Throughout the duration of the study, ERT and UCLA remain in constant contact to discuss what’s working, revisit the objectives, ensure progress is in line with their goals and ascertain if there are any improvements that could be implemented. Some of the main challenges associated with the study have been the high number of participants required for the ambitious project and, consequently, the high volume of data resulting from the program. As a result, additional time and effort has had to be contributed by both parties to ensure that all the data is collected and analyzed in the most efficient and effective way possible.

Built on a 12 year relationship, ERT and UCLA both demonstrate a clear understanding of and commitment to helping each other achieve their aims. A key difference between this trial and similar ones is the dedication of both parties to developing new methods that will provide information about what is really important to COPD patients. This patient-centric approach goes further than simply mimicking existing research; it has resulted in the development of a questionnaire tailored to the specific objectives of the study by collating information on multiple parameters including not only data on sufferers’ symptoms, but also information on physical activity and patients’ medications. ERT and UCLA have combined their technologies, knowledge and expertise, with the aim of changing the lives of patients living with a condition where the burden of illness is high and the need for quick intervention, vital. Without the involvement of either party, the volume of data and participant numbers would simply not be attainable by the organizations individually. Bringing their resources together means that the study will be able to successfully demonstrate the benefits of on-going symptom management, early intervention of exacerbations, and on-going patient assessments for medication; helping to progress the adoption of remote healthcare monitoring.

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