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Clinical trials in the cloud(Medical Design Via Acquire Media NewsEdge) ARTICLE FOCUS: Complexity of imaging based clinical trialsCloud benefitsApplying SaaSClinical trial image management for medical devices has joined many other technologies in the "cloud," providing on-demand access to software applications via the Internet. This cloud computing approach, known as Software-as-a-Service (SaaS), is offered via a subscription or "pay-as-you-go" model, and is providing numerous benefits to increase the efficiency and effectiveness of clinical trials for devices. In order to appreciate the magnitude of these benefits, it's important to understand the cost and complexity of today's clinical trials. With some medical devices costing in the $25,000 range, and because each clinical trial participant must be given the device, experts have estimated that a clinical trial for a medical device can cost a manufacturer anywhere between $500,000 and $10 million, with implantable devices such as heart defibrillators exceeding those numbers. Therefore, device manufacturers must be able to make cost-effective go/no-go decisions as early as possible during the clinical trial process based on available data, which can be overwhelming. Dealing with overload Moving from paper-based to electronic processes has significantly improved the ability for trial sponsors to capture, analyze, and report data; however, the requirements to collect more data and new types of data has made the management process even more challenging. As technology has advanced, images have become important tools in medical device clinical trials and the ability to integrate them into the overall clinical trial is critical to the success. Images of a human body before, during and after a medical device is used or implanted, can reveal how well the product works and whether it is safe for the patient. Therefore, during the clinical trial process, sponsors collect a wide range of images, often from different sources and at multiple locations. To properly manage these images, it is important that sponsors have cost-effective clinical trial image management solutions in place. The right solution can ensure the quality and integrity of the data from receipt to final data transfer, provide flexibility to enable collaboration; and offer the scalability to grow as the organization and its clinical trial needs increase. With such solutions, medical device manufacturers can also gain back control of their clinical trials and be able to selectively outsource certain components of their trials. Navigating bumps in the road Current technology solutions such as enterprise archival systems, imaging core labs, electronic data capture systems, and custom-developed in-house solutions, are designed to address today's data management issues. Still, challenges remain, including: Potential for errors, due to the increased complexity of clinical trials. When errors occur, delays happen and costs increase. Also with QA/QC done later in the process, the potential for error increases.Lack of control when using external parties to manage trial data. Without timely access to data, trial sponsors are rarely able to make course corrections that may limit risk while containing costs.Inflexible solutions often dictate what sponsors can and cannot do.Expense and inefficiencies related to labor-intensive processes.Lack of standards to follow from trial to trial.Standalone solutions don’t integrate well with other systems, hindering collaboration.Inadequate functionality associated with reverse engineered technology solutions that are not very comprehensive.Back to the cloud Now that we've established where medical device clinical trials have been in terms of cost and complexity, it’s time to head for the "cloud" and discuss the potential for increasing the efficiency and effectiveness of medical device clinical trials. Here, then, are the benefits of a cloud computing approach: Page 2 of 3 Rapid trial start. By accessing the software application via the Web, all the users need is a computer with an Internet connection. There is no need to install and configure software on individual PCs. With this delivery model, clinical trial sponsors have the ability to start a trial and collect data within just a few weeks of using a private or public cloud. If the sponsor has multiple locations, it is a simple, low cost way to get multiple sites up and running with no updates or upgrades required during the process. That is all handled by the software provide via the Internet and the users always have access to the latest version of the software. Real-time access to data. A SaaS-based solution enables a sponsor to bring their full trial, or part of their trial, in house and gain complete control of their data by having real-time access to data throughout the trial. T The more involved the sponsor is in the development process, the greater their learning and subsequent impact will be on the design, execution and outcome. With real-time access to data, sponsors have the transparency they need throughout the trial process and the flexibility to outsource or insource specific components of the trial. Tight security and full compliance. Most clinical trials are performed from multiple locations and have multiple organizations involved in the process. A SaaS-based clinical trial image management solution enables sponsors to easily share image data with external parties without compromising security or regulatory policies. Sponsors can collaborate with readers and scientists anywhere in the world without having to move physical images or risk the integrity of the data. A SaaS-based clinical trial image management solution can also help the sponsor to comply with industry and governmental regulations quicker and at a reduced effort and cost. Comprehensive functionality. SaaS-based does not mean sponsors have to sacrifice functionality; in fact, there are solutions that provide all the key functionality of an imaging core lab, plus more. First, by selecting a solution that was purposefully built for clinical trials will provide more comprehensive functionality than a product that has been reversed engineered for clinical trials, such as PACs or RIS systems. A product that has been designed specifically for clinical trial sponsors will allow the management of DICOM and non-DICOM data and offer the workflow functionality needed to standardize processes throughout all stages of the trial. A robust solution will offer the ability to customize workflows for each trial and also set standardized workflows from trial to trial for increased productivity. An example of a company that offers SaaS-based solutions specifically designed to meet the challenges of medical device clinical trial sponsors, is Belmont, MA-based Radiant Sage. The company’s solutions, Core-Lab-in-a-BoxTM and RadVista Viewer, enable rapid trial start and increased overall efficiency of the collection, distribution, and processing of images and related data without any capital infrastructure investments. In addition to Core-Lab-in-a-BoxTM, Radiant Sage also offers a cost-effective SaaS based archival solution called Image Collaborative Portal,TM which is ideally suited for archival of trial data for a long period of time after product approval with real-time access as required. This not only meets the regulatory requirements but also provides access to relevant data across multiple trials to aid critical R&D efforts of sponsor organizations. Data queries and retrieval can be done via easy to use tools using standardization rules, a variety of query interfaces with the ability to re-use complex queries. Intended for small, quick trials (e.g. proof of concept and methodology trials), the SaaS-based delivery model enables sponsors to retain control of their clinical trials by leveraging cost-effective, efficient, and accurate image management solutions either by conducting the trial in-house or outsourcing all or part of it. With remote access, clinical trial sponsors can make use of skilled and low-cost resources anywhere in the world using the company’s remote rendering feature. And to ensure data integrity and compliancey with regulatory requirements, Radiant Sage’s secure, real-time software enables testing of the image output from devices (e.g. scanners and ultrasound machines). Page 3 of 3 Applying SaaSStents and orthopedics are two good examples of how SaaS-based clinical trial image management solutions can be used by medical device manufacturers. When an imaging CRO is contracted to oversee the clinical trial process for a cardiovascular stent device, the CRO receives images from multiple sites. Some images are sent via FTP, others are sent on electronic media by mail, while yet others are sent on film by courier. Some of the electronic data is DICOM, others are in vendor proprietary formats. Upon receiving the image, the imaging CRO scans the films into a digital format, converts the proprietary formats to DICOM, edits the DICOM fields to remove private tags and patient identifying information, adds any essential meta data that is not already with the image data, performs image QA/QC, and loads the data into the Saas-based clinical trial image management system. A digital scan is done before and after the procedure, which may show an inclusion with a 5% change. Another image done six months later to determine if any change has occurred will establish whether the stent is working or not. The loaded images can then be shared with project team members, management, the development team, and any external collaborators using customized workflows. The images can also be reviewed or analyzed as necessary and “read” using blinded reading protocols. The costs associated with using the system are far less than costs associated with traditional methods due to the utilization of cloud computing technology. Another example of applying SaaS is a hip replacement clinical trial. After the collection of the study data is complete, the CRO pulls the images from the repository. A semiautomated software tool is used to segment a region of interest on the images. The segmentation bit map is stored in the system. The data is blinded and randomized for the read. Multiple radiologists are recruited to interpret the segmentation results, and they are allowed to make adjustments to the computer generated bitmap. The data is read multiple times with each radiologist blinded to the findings of the other radiologists. Results are stored back into the Saas-based clinical trial image management solution and final reports are generated. A SaaS-based solution makes the entire process highly efficient providing role-based, real-time access to images and related data to various participants to fulfill their responsibilities in the clinical trial process. Radiologists, key opinion leaders and other experts can be anywhere in the world and access the images without the need for a physical transfer of images – and it can all be done in a secure, regulatory-compliant environment. Today’s forecast: plenty of cloud Clinical Image management technology has come a long way and cloud computing is now enabling more medical device companies to leverage sophisticated technology without making significant financial investments. Today, speed and accuracy are a must for medical device manufacturers. SaaS-based clinical trial image management solutions provide an easy-to-access central repository of images and associated data that enable trial sponsors to make go/ no go decisions as early as possible and hopefully bring more safe and effective products to the market quicker and at a lower cost. © 2011 Penton Media |