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Many years before the FDA offered its eSource Guidance in September 2013, Sirion Therapeutics launched its first two pivotal Phase III studies using entirely electronic source data collection.
In September 2013, Sirion Therapeutics launched its first two pivotal Phase III studies using entirely electronic source data collection. In those trials for the safety and efficacy of Difluprednate for the management of inflammation following ocular surgery, Kim McLeod, former Vice President of Clinical Operations at Sirion and currently Director, Prospective Research at Xcenda, said, “Electronic source made the most practical and economic sense; however in researching the topic, we discovered a lack of FDA guidance, an absence of industry case studies, and no subject matter expertise such as consultants with experience in submitting a 100% electronic source study to the Agency.”
Kim continued, “The objective was to enroll 120 subjects into each study quickly, and from start to finish – complete the development, preparation, execution, enrollment, analyses and reporting of the studies in less than six months and within a tight budget. Centers were ophthalmic surgical suites with varying degrees of clinical trial experience. The need for a mobile data collection process was imperative to the success of the study as data collection would come from originating sources to include the surgical investigators, study coordinators and EMRs.” A mobile collection process are processes that would support mobile devices that would allow for direct data entry and devices connected to the Internet.
According to Kim, Sirion needed an intuitive, all encompassing, reasonably priced data collection system to obtain reliable data in real time while managing study related costs. Also, a mobile data collection process was critical due to the various sources and the need for investigators to remain in motion.
The company selected DSG, Inc. to meet those requirements, and it designed, programmed, validated and launched a single, seamless solution. Sirion experienced fewer anomalous data points and the data was cleaner upon data entry due to the proprietary nature of the eCaseLink EDC system, which used a higher quantity of complex edit check protocol validations than what would be considered industry standard.
For the sites, Sirion provided each with a wireless tablet and equipment required for wireless access to the EDC system, which allowed them to enter patient data directly into the EDC system--with no intervening paper step. Electronic source and the use of WIFI internet-enabled tablets gave surgeons and study coordinators the mobility they coveted while completely eliminating paper source documentation. This removed the need for source data verification, and dramatically decreased monitoring time and costs for Sirion.
Company executives were kept current on the progress of the study via reports generated within the eCaselink system. Due to the efficiencies of eSource, the time to database lock following last subject--last visit was significantly shorter, allowing Sirion to proceed to conducting the analysis and to receive study results expeditiously.
When the FDA conducted in-house and site audits as part of the NDA process, Sirion and DSG worked together to support the use of eSource captured directly into eCaselink EDC with IWRS (randomization with drug tracking and allocation). The FDA auditor assigned to Sirion was unaccustomed to these methods of data collection and drug tracking, however, could easily understand the validations and documentation. The auditor thoroughly investigated the database design and validation; data collection process at the sites; drug accountability and tracking; and remote monitoring procedures. He closed the audit with a positive review, ultimately leading to FDA approval of Difluprednate on June 24, 2008.
“As one of the original EDC companies taking a product to market back in 1999, we remember well the push-back against what was then a new technology promising to substantially reduce resources needed to conduct a trial. eSource for pivotal studies was also regarded as taboo amidst warnings and fear mongering of NDA rejections when in fact, FDA desires eSource, and so here is your proof, “ said Tony Varano, CEO of DSG. “We are always excited to see new applications complimenting EDC and dramatically reducing resources required to perform a clinical trial. Eliminating paper data review with eSource and now with risk-based monitoring are resource game changers for our industry.”
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