WorldCare Clinical: Harmonizing Clinical Trial Imaging for Maximum Effectiveness and Cost EfficiencyFaced with extraordinary growth in the cost of developing new therapeutic treatments, companies in the pharmaceutical and medical devices industries are constantly seeking new methods to reduce expenses while maintaining, or increasing, the pace of development. More than ever, these companies are looking to clinical trial imaging service providers – often called imaging CROs -- to help them bring new products to the market in a faster and more cost-effective manner.
Clinical Trial Imaging Today A number of market factors are driving the need for harmonized clinical trial imaging. Among the most important are cost considerations and federal government initiatives. Recent evaluations of biopharmaceutical product development processes for innovative drugs have produced surprising and, to many, worrisome results. Studies show that the costs of bringing a new drug through the discovery and development process to market have more than doubled over the last ten years and have been estimated at between $897 million and $1.78 billion per drug in 2000-2002. A substantial portion of this increase is in the costs associated with clinical research.
While development costs are rising, there is reason to believe that the clinical development phase is actually becoming less productive. Recent analyses have shown that historically, a new medicinal compound process entering Phase 1 trials has a 14% chance of reaching the market. Since 2000, this rate has dropped to an 8% chance of success. Finally, an analysis of drug development spending shows that 75% of total drug development expenses are for products that fail to come to market.
In response to this situation, the FDA has launched its “Critical Path” Initiative, working with industry, academia and regulators to “…identify and prioritize areas that provide the greatest opportunities for rapid improvement and public health benefit.” This is a national effort to modernize the scientific process through which a potential drug, biological product, or medical device is transformed from a discovery into a medical product.
The scope of this effort underscores the growing emphasis placed on imaging in clinical trials. In fact, a recent report issued by the Initiative focuses on imaging as a core technology for the cost-effective assessment and acceleration of the therapeutic development process.
In this approach, a vital role in the successful clinical trial is played by the imaging CRO responsible for collecting consistent, high-quality imaging data and ensuring minimal variability through central reading. Acting as a partner to the sponsor of the trial, the imaging CRO helps design appropriate imaging acquisition protocols and provides the services needed to implement and manage the imaging portions of trials (these include imaging site qualification and coordination, independent radiologist reading services, quality control, regulatory submissions, and other related tasks). In short, the imaging CRO is charged with harmonizing all the elements of the image acquisition and management process.
New research indicates that the use of clinical imaging biomarkers in the early stages of pharmaceutical testing is assisting companies in their ability to make “go/no-go” decisions in the early stages of the drug development process, improving its efficiency and cost effectiveness. Data is available sooner, allowing companies to make critical decisions regarding the progress of a compound.
Key Components of Successful Clinical Trial Imaging Processes In clinical trials, the supervision of imaging centers is part of the overall imaging process managed by an imaging CRO. The imaging CRO oversees the collection of consistent, high-quality imaging data and ensures minimal variability through central reading. When managing multi-site imaging studies, the imaging CRO must take into consideration a number of factors in order to coordinate and standardize protocol to minimize data variability. These include:
Imaging Charter and Image Acquisition Protocols - The imaging CRO can provide clinical trial sponsors with guidance in designing and appropriate Independent Imaging Review Charter (imaging charter) for submission to the FDA. It is also responsible for the image acquisition protocol, typically as part of an image preparation and submission guide, developed before the study begins. The documents specify a standard manner for acquiring, managing, and assessing images to ensure that data from multiple imaging sites is collected consistently.
The imaging charter provides details of how reading interpretations will be executed with the central reviewers and documents how the reader(s) will be qualified and trained, and how response criteria are to be used. The charter serves as the official record of the central reading processes and it is recommended that this document is submitted to the FDA for approval prior to the start of any central reads.
Technologists at imaging sites must receive training so that they fully understand the details of the acquisition protocol. In addition, the imaging CRO will prepare image preparation and submission guidelines and instruct imaging site personnel on the processes for delivering all images, and data to the imaging CRO and for archiving relevant images and data on site.
The imaging CRO ensures that the image acquisition is managed according to protocol, and constantly provides feedback to the imaging sites to ensure that consistent, high-quality data is obtained. To ensure protocol compliance and reduce data variability, continual review and monitoring of the imaging sites should occur over the duration of the trial as part of a rigorous and well-documented quality control process. For example, the imaging site should be responsible for blinding any identifying patient data from image and data records before sending data to the imaging CRO. As part of the quality control process, the imaging CRO verifies the blinding of patient identifiers. The process should also include a thorough quality review of images received by the imaging CRO, as well as monitoring to ensure that the acquisition protocol is being followed. All deviations require the issuance of a query to the image acquisition site and should be recorded and archived. Throughout the study, the imaging CRO performs a quality assurance review to determine that in-house procedures are being followed appropriately.
Images and data collected from multiple imaging sites will inevitably be delivered to the imaging CRO in many different formats. Depending on a site’s technical capabilities, the imaging CRO may receive DVDs, tape drives, optical disks, or even sheets of film or videocassettes. Data transfer between imaging sites and the imaging CRO may happen electronically or via overnight delivery service. Even though modern imaging equipment is generally compliant with the Digital Imaging and Communication in Medicine (DICOM) standard, some devices produce files that need special decoding or translation. The imaging CRO will have specialized image processing software that can read and translate multiple electronic formats to a common file format, as well as the ability to digitize film and videocassettes. To reduce the potential for errors, this data management software should avoid the use of manual techniques as much as possible. A multi-site imaging clinical trial will result in mountains of electronic information. An imaging CRO should have the technology and skills to manage large volumes of data. This is particularly true when it comes to submitting studies—secure electronic filing technology makes it easier for regulatory agency reviewers to access and wade through reams of data. Reading Services - Imaging CROs offer blinded reading services from qualified radiologists who are either on-staff or are independent of the sponsor and clinical imaging site. Imaging CROs that follow a decentralized reading service model often achieve the most effective results, because they are able to utilize the most appropriate, expert reader for each particular image regardless of their location or affiliation.
Before the study begins, the imaging CRO develops radiology review guidelines that detail the response criteria, review process, and training for the duration of the study. These processes and criteria are shared with readers who are on staff or work in partnership with the CRO, bringing specific expertise in such fields as oncology and radiology. Careful management and monitoring of the process allows the CRO to reduce reading variability because all physicians are similarly trained and have the same “reading culture.” Any reading issues can be addressed immediately and consistently.
Workflow Management - Workflow management is a critical component of managing multi-site clinical trials. The best imaging CROs use technology that is configurable to the specifications of each clinical trial— generating events, notifications, and task lists for each trial segment.
Such a workflow technology can deliver advance notification to clinical sites of subject visits to ensure site preparation and timely image receipt. Because receiving images from multiple sites can be complicated to track, good workflow management software delivers notification of receipt of scans to CRAs and IRAs so that they can begin processing.
An imaging CRO with advanced workflow management software allows imaging sites with web-based image and data transfer capabilities to send study information directly via secure portal. The best software provides a complete audit trail, centralized database, and image management tracker that make it easier to track the receipt and processing of images from multiple sites.
The WorldCare Clinical Advantage WorldCare Clinical (WCC) is setting the standard for the use of imaging in the development of new therapeutic compounds through its unparalleled legacy of radiological excellence, its world-renowned medical expertise, and its technological innovations. WCC offers end-to-end, fully harmonized imaging services in support of clinical trials for the pharmaceutical, biotechnology and medical device industries. Assembling radiology teams with world-class therapeutic expertise, WCC offers independent reader services in multiple modalities and disease states, an extensive global teleradiology network and workflow process that ensure maximum data set cleanliness and consistency, and proven experience in managing the imaging process for clinical trials.
WCC’s customer-centric approach, technological expertise and industry heritage deliver a number of significant advantages to sponsors:
WorldPro reduces study shipment costs associated with image acquisition as images are uploaded remotely and provides efficiencies to the image acquisition process by reducing queries and providing increased image quality, consistency and reducing turnaround time and costs for the sponsor.
In addition to providing clean data, the advanced WorldPro technology platform ensures the most logical and efficient workflow among the imaging sites, WCC, radiology readers, and the trial sponsor. A smooth and productive operational process enables WCC to meet the demand for fast turnaround times, without sacrificing data quality.
Sponsors have ultimate control, with the ability to view the entire imaging component of the trial through the WorldView web portal. And the advanced transmission technology and efficient network allows for the radiologists of their choosing – no matter where they are in the world – to provide reading services.
Tailored to each sponsor’s specific needs, WorldPro can be configured to the unique specifications of any trial providing clean data for faster FDA submission. Customizable tools include:
WorldPro provides one of the most stringent audit trails in the industry, and ensures all study images and other collected data are of the highest quality and are completely secure throughout the course of the trial.
WCC’s extensive experience working with challenging imaging sites allows the company to qualify sites that may otherwise by rejected. By focusing on an individual site’s hardware and software, WCC can customize an imaging protocol that maximizes the quality of images obtainable in even the most remote regions.
WCC provides the industry standard for reader consistency through reader training and testing at study startup. WCC’s WorldPro technology provides a 21 CFR Part 11 compliant platform in a controlled environment to house data sets while monitoring reader consistency throughout the trial. This ensures high-quality real-time reads.
Based on its access to this expertise, WCC is able to offer sponsors its unique thought leadership in working through review criteria to determine appropriate imaging modalities and design trial protocols. WCC’s proactive project management ensures quick resolution of issues at imaging sites, leading to consistent, high-quality data and images.
In addition to its strategic partnerships, WCC’s secure image transfer capabilities make it possible to send images for review to any radiologist at any location the sponsor chooses, as long as the receiver has high-speed Internet access and a correctly configured reading station.
This unique business model, which uses independent reader services provided by the sub-specialty radiologists at some of the world’s preeminent medical institutions rather than an in-house radiological staff, means that WCC can augment its medical image analysis and interpretation capabilities and scale up to accommodate sponsors’ needs for a nearly unlimited number of reads. With radiologists offering sub-specialty expertise in such fields as oncology and neurology, WCC’s partners bring specialized image reading services to its clinical trial capabilities for sponsors. Adding to WCC’s strategic relationships with ProScan Imaging, the Massachusetts General Physicians Organization, and UCMC, WCC’s ability to securely send images to any radiologist in the world expands the staff of expert radiologists available for each clinical trial.
The highly trained sub-specialty radiologists are a tremendous asset to the WCC team. Its partners bring their analytic capabilities to WCC’s imaging core lab services to help WorldCare Clinical achieve its mission -- to increase the efficiency of the drug development process and speed the time to market of new drugs cost effectively.
WCC provides sponsors with radiologists and technologists with expertise in a variety of imaging modalities, including PET, SPECT, CT, MRI, ultrasound, DEXA, ECG, X-ray and Bonescan. WCC’s rigorous quality assurance and control processes safeguard the integrity of images and data.
By accessing sub-specialty radiologists, WCC is able to consult on protocol development and identify appropriate imaging techniques. In addition its scientific advisory board comprises nine widely respected experts in their fields, which include medical, radiology and digital imaging.
WorldCare Clinical – Harmonizing the Clinical Trial Imaging Process As the use of imaging in therapeutic drug development continues to grow, so does the need for harmonization of imaging procedures. WorldCare Clinical is dedicated to continuing to lead the industry by employing its therapeutic knowledge, modality expertise, innovative technology, operational excellence and proven regulatory experience in complete harmonization to speed the discovery and delivery of new therapeutic treatments that improve patient quality of life. |
