The Paperless Clinical Trial: Closer than You Think

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<strong>London</strong><br />Life sciences companies globally are turning to e-clinical solutions, in particular electronic data capture (EDC) and clinical trials management systems (CTMS), in a bid to improve inefficiencies and cut costs during the most expensive phase of drug development: clinical trials. <br /><br />On average, life science companies spend between $12 and $17 million yearly on mailings and copies of paper case report forms. With the implementation of e-clinical solutions, a company could save anywhere from $10-$15 million a year on paper and postage alone. This is according to the latest report by independent market analyst Datamonitor, titled &ldquo;In Pursuit of the Paperless Clinical Trial: A Look at EDC and CTMS.&rdquo;<br /> <br />The report investigates technology solutions that will be integral to streamlining the clinical trials process and said firms spend nearly $1 billion to bring a new drug to market, of which $500-$700 million is spent on clinical trials. <br /><br />Several pharma companies and CROs have already developed strategies to use EDC for 100 percent of their trials by 2012. Although there are several roadblocks ahead, Datamonitor believes the adoption of EDC will be rapid through 2012, at which point it will plateau out. The industry will also see an increase in the adoption of CTMS as management becomes a greater issue due to the globalization of clinical trials.<br /> <br />&ldquo;The adoption of EDC and CTMS solutions will be integral in enhancing and transforming the data collection and management aspects of a trial,&rdquo; said Ruchi Mallya, pharmaceutical technology analyst at Datamonitor and author of this study. &ldquo;<br /><br />An efficient e-clinical platform will provide companies with substantial cost and time savings and will play a vital role in changing the research process for the better. A comprehensive e-clinical platform will also play an important role in promoting public health.&rdquo;<br /> <br /><strong>E-Clinical Solutions Enable Adaptive Trials</strong><br />Life science companies are facing many challenges, such as declining product pipelines, increasing government regulations, soaring R&D costs, rising safety concerns and severe competition from generic drugs &mdash; all leading to a decrease in yearly sales. <br /> <br />There has been a lot of talk of conducting adaptive trials as a means to accelerate the drug development process. Through this process, pharma and biotech companies have the flexibility to analyze study data before the end of the trial and change its design to either improve the chances for a better positive result or cancel the trial if the drug appears ineffective. <br /> <br />EDC allows for a centralized, standard workflow to easily collect, clean, validate and manage patient data. It provides real-time, permission-based access to high quality data that is critical to a time-sensitive process in which only a limited user-base may be exposed to the data. <br /><br />CTMS provides a platform to track and manage all nonpatient information related to a trial. A CTMS allows sponsors to maximize clinical supply usage based on patient enrolment of each treatment arm that could change midtrial. <br /> <br />&ldquo;E-clinical technologies play a vital role in the successful implementation of an adaptive trial&rdquo;, said Mallya. &ldquo;Adaptive trials require continuous analysis and monitoring of unblinded clinical data, which is performed by a group of statisticians and researchers who are not allowed to communicate with the rest of the clinical research team. E-clinical solutions empower sponsors, researchers and statisticians with real-time data, enabling them to make critical modifications to the trial.&rdquo; <br /> <br /><strong>Interoperability Is the Key to the Future</strong><br />An e-clinical platform does not consist of just an EDC or CTMS solution, but rather a whole suite of systems. Currently, these systems exist in silos and are connected through point-to-point integrations. <br /><br />&ldquo;To fully leverage the benefits of these technologies, e-clinical solutions must be built on an interoperable framework that will enable life science companies to run clinical trials in a more efficient manner since many redundancies which currently exist in the point solutions will be eliminated. An interoperable platform would allow for greater visibility into the clinical research process, and greater collaboration among various departments and stakeholders within an organization.&rdquo; <br /> <br />Life science companies will need to coordinate their R&D and IT priorities to invest in an infrastructure that delivers an interoperable clinical environment. But since pharma companies do not possess expertise in interoperability, they will rely on external expertise to help them develop this framework. <br /><br />According to Mallya, &ldquo;Vendors that provide an interoperable e-clinical platform will be leaders in the clinical technology market, as pharma companies will turn to them to augment their in-house IT departments and boost their business strategies.&rdquo;<br /> <br /><strong>EDC Adoption Requires Major Paradigm Shift</strong><br />While clinical solutions, particularly EDC, have existed for more than 20 years, adoption of these systems has been much slower than initially anticipated, due in large part to a lack of support from end users. <br /> <br />&ldquo;EDC adoption requires a major organizational and process paradigm shift&rdquo;, said Mallya. Many researchers and investigators who are accustomed to the paper-based system are not ready to make that change. Until all stakeholders in the clinical trial process are educated on the true features and benefits of modern clinical technologies, and are willing to make the necessary mental and cultural switch, implementation of e-clinical solutions will remain sluggish.&rdquo;<br />

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