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Electronic submission of diagnostic medical imaging can be utilized in clinical drug trials to speed the submission and independent analysis of medical imaging diagnostics by central imaging labs while also increasing quality of data.
Introduction
Electronic submission of diagnostic medical imaging can be utilized in clinical drug trials to speed the submission and independent analysis of medical imaging diagnostics by central imaging labs while also increasing quality of data. This message is apparently spreading across the clinical trial space, as we are seeing more and more clinical trials and central labs utilize electronic image submission (EIS) solutions every day. There are multiple companies offering different types of EIS services to clinical trial sponsors and central imaging labs and there are also multiple ways to implement them. For the purposes of this article, we will explore the application of EIS solutions utilizing Java programming language with HTTPS/DICOM protocols in clinical drug trials and how it may specifically benefit them.
How it Works
A “Thin Client” browser-based application allows a clinical investigator site to upload medical diagnostic images (i.e. CT, MR, XRAY, etc…) from their local office to a server hosted by an EIS provider. This technology allows the user to download and use the application without encountering firewall/security issues. An applet can perform trial specific de-identification of the medical diagnostic image data and allows the user to fill out an associated electronic form to capture any additional information necessary for the trial. This type of EIS workflow typically consists of the following simple steps:
- Clinical investigator site acquires images via imaging modality. (ex. Computed Tomography - CT, Magnetic Resonance Imaging - MRI)
- Once images are acquired, the data can be pushed to a local machine containing the EIS software from the modality via PACS, or a CD can be burned for manual upload to the local machine. The PACS can also be queried via the EIS system through user specific parameters. (ex. Patient demographics)
- Site logs into the EIS provider website (with confidential username/password).
a. Site downloads java applet.
- Site uploads images from local machine.
- User performs de-identification
- Site completes the electronic image transmittal form (eITF) (if applicable).
- The e-ITF can contain logic to validate what the user inputs into the form. Edit checks and prompts can be utilized to keep users from making typographical mistakes, as well as force comments for deviating from imaging protocols.
- Image transfer from site to EIS provider is complete and an E-mail notification goes to the central imaging lab to retrieve the images and eITF information from the EIS provider.
- Central imaging lab notifies site of image receipt and acceptance.
What are the Benefits?
Below are some of the most significant benefits of using an EIS solution in clinical trials where medical diagnostic imaging is being centrally collected and analyzed:
- Cost Savings: There is significant potential for cost savings when using EIS. One should generally be able to realize 50% or more reduction in pass-through costs related to transferring images from the clinical sites to a central lab.
- Accelerated Image Submission: When utilizing tradition courier shipping methods to transfer images, delays in getting the images to the central lab are very common. These delays are typically caused by lost packages/customs issues, the time it takes for a package to be physically delivered, and clinical site compliance issues. EIS completely eliminates the chance of lost packages/customs issues, dramatically reduces the time required for the images to reach the central imaging lab (same day with EIS vs. ~2-5 days with courier shipping methods), and also increase site compliance through the user-friendly web-based solution of EIS.
- Increased Data Quality: EIS allows for increased data quality and decreased data discrepancies through its ability to automatically compare, catch, and allow resolution for image discrepancies between the images being submitted by the clinical investigator site and what is required for the trial before the images are actually submitted to the central imaging lab.
- Accelerated Data Delivery: Through the combination of accelerated image submission and increased data quality, the images can be received, processed, and independently analyzed by the central imaging lab significantly sooner than would be possible without EIS.
Conclusion
There are a number of different EIS providers and not all of them provide the same type of service or features. Some considerations to make when selecting an EIS provider: Do they require software/hardware to be installed at the site (this can be problematic)? An alternative solution is a web-based EIS provider that utilizes applet technology which eliminates most security/firewall obstacles faced. Do they offer clinical investigator site training? It is important that the sites feel comfortable using EIS and this comfort can be reached via proper training (EIS provider should train at investigator meetings, provide web-based trainings, and offer one-on-one site trainings if necessary.
Do they offer adequate support? Finding an EIS provider that offers 24/7 helpdesk support to the clinical sites is ideal. Do they offer image blinding/anonymization features? Some sites are unable to remove patient identifiers from the images they acquire prior to submitting them to a central imaging lab. Do they offer the ability to integrate their EIS solution with the technology in place at the central imaging lab you are working with? Some of the benefits listed above cannot be fully realized without this option. Lastly, can their EIS solution allow for transmission of non-DICOM formats (JPEG, AVI…)? This may be critical, depending on the type of medical imaging modality and associated image file types a clinical trial requires.
As the landscape of clinical trial management continuously changes, we are faced with many opportunities to further improve the efficiency and effectiveness in conducting clinical trails and ultimately bringing much needed medical treatments and solutions to the market. Electronic image submission is one of these new opportunities and if utilized correctly, can bring significant benefits to a clinical drug trial utilizing centralized, independent image analysis.
Nicholas R. Enus is Senior Project Manager of the Oncology/Cardiology Medical Imaging Group at Perceptive Informatics Inc, a PAREXEL company. Nicholas joined Perceptive in 2003. During the past six and a half years, he has had extensive experience in a wide range of global clinical trials and imaging techniques, including oncology, cardiovascular and CNS. Nicholas graduated cum laude with a Bachelor of Science degree in Exercise Physiology from the University of Massachusetts, with a double Minor in Clinical Lab Sciences and Psychology.
Keith W. Persson is the Associate Director or Imaging Operations at Perceptive Informatics Inc, a PAREXEL company. Keith joined Perceptive in 2001. During the past 9 years he has gained extensive therapeutic experience in both early and late phase clinical trials, including oncology, CNS, muscular skeletal and cardiovascular areas as well as medical imaging modalities of CT, MRI, Ultrasound, Echocardiography, DCE-MRI, X-ray, Mammography and PET. Keith is a graduate from Quinsigamond College and Bellevue University. (Associates in Occupational Therapy / BS in Computer Science)
Stephen W. Bates is Program Director of the Oncology/Cardiology Medical Imaging Group at Perceptive Informatics Inc, a PAREXEL company. Stephen joined Perceptive in 2001. During the past eight and a half years, he has had extensive experience in a wide range of clinical trials and imaging techniques, including the performance of both oncology (RECIST/Cheson) and CNS volume measurement. Prior to joining Perceptive, Stephen was a U.S. Navy and Nationally Certified Orthopaedic Technician. During his military service, Stephen spent two years in Japan as the Leading Petty Officer for the Orthopaedic Surgery Clinic attached to U.S. Naval Hospital Yokosuka. Stephen has an MS in Technology Management, and holds a BS in Cell/Molecular Biology (summa cum laude), both from Bridgewater State College.
For article feedback contact Enus at Nicholas.Enus@perceptive.com
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