Applied Clinical Trials
Clinical professionals can recreate CTMS by applying modern technology in a new way.
Reinventing eClinical is not about breakthrough technology. Pharmaceutical companies and a highly-regulated clinical trial environment just don't work that way. Many elements are changing, but we still need to do the same things-track enrollment, randomize patients, and, of course, collect the data in a secure and verifiable fashion. What's not the same? Clinical trials have increased in size and complexity, partly the result of more global trials being conducted with sites across multiple geographical regions. The need to scale across partners, across vendors, and across the globe has combined with new business models and economic imperatives to fundamentally transform the requirements. Mix in the expectations generated by the everyday exposure to technology all around us and it's easy to see why yesterday's solutions just don't cut it anymore.
If reinvention isn't new technology, then what is it? It's re-imagining the processes and then applying modern-yet-proven technology with a fresh approach. By taking advantage of technology already in use within the IT infrastructure and on most business computers, such as Microsoft® Office, life science companies can change the way clinical professionals interact with their clinical trial management system information. When an organization is ready to look at a new CTMS, here are some of the capabilities that should be included in the RFP.
A CTMS should help mine a list of clinical investigators and pinpoint the ones that are best for a trial. For example, for an asthma trial the user can search all investigators with pulmonary experience, and then narrow it down by focusing on those investigators that have acceptable enrollment rates and/or those who have fewer protocol deviations. In the past, this type of information was scattered throughout the organization with each clinical team maintaining their own list of clinical investigators and separate quality metrics. A CTMS should centralize this data and make it more accessible to the decision makers that need it.
Good Clinical Practice (GCP) regulations stipulate which documents must be collected by the clinical sponsor, but no study is completely straightforward. The list of regulatory documents that a sponsor requires varies with the type of study, sponsor preferences, and even the location and experience of the site. Using CTMS, studies can be configured to require different documents for each study phase: initiation, startup, maintenance, and closeout. A CTMS should prompt the correct personnel to collect the required documents as each qualifies to participate in the study. Details about each document and the document files are accessible by permitted users and routed for review and/or approval. This process replaces the disconnected spreadsheets and checklists traditionally used by study personnel by maintaining a centralized, up-to-date list of all required regulatory documents, eliminating the need to check and recheck study binders.
How much of a study budget has been spent? How much remains? Answering these two questions can be challenging when using a CTMS without inherent clinical payment features. Calculating all the payments to various vendors, contractors, and clinical sites is a task that takes many companies days or weeks to perform.
To be truly useful, the CTMS should support options such as holdback and overhead percentages. It should allow you to simply define your study budget and specify the key factors that will determine payment amounts such as the type of services that may be provided for each vendor and the number of subjects projected for each site. Sites can then be paid on completed CRFs, procedures, milestones, or a combination of factors. EDC should easily integrate with your CTMS to automate the process and provide full traceability from sites entering data into EDC through payments going out the door on time and in the correct amounts.
Speed. Collaboration. Flexibility. Words not typically associated with traditional CTMS implementations, which are usually heavyweight, on-premise systems that require extensive customization and expensive, time-consuming upgrades to make process changes. Shouldn't technology support and foster better processes? Consider the value of software-as-a-service. If your vendor does more than simply host the application, it will be self-service without the worry associated with supporting the application and infrastructure.
Speed applies to implementing a new system as well as supporting new studies. The faster you can deploy studies, the better your flexibility to support new business processes. Legacy technology requires so much customization that it can be out of date before it's fully functional while impeding process improvements. Speed naturally supports flexibility.
Collaboration means more than just being able to share data. It translates that data into targeted information based on user roles and support for better communication between teams. Tools like global contact databases and document repositories help to ensure clarity and support speed. Configurable workflow distributes work amongst the team with appropriate approvals and audit trails along the way.
You need to be able to integrate with other systems using open interfaces both to efficiently consolidate information from other systems as well as to share it with the many authorized participants who may benefit. It is indispensable for a CTMS to have accurate data on information such as patient enrollment and CRF completion. Manually entering data into your CTMS after they have been entered into other systems is labor-intensive, error-prone, and necessitates costly conflict resolution. Only through efficient inbound integration can you obtain a clear, timely picture of study conduct.
Outward-facing integration supports on-demand access to current trial data to make timely decisions. This involves much more than reporting and exporting. Practicality is not about denying spreadsheets, it's about harnessing them. What does this mean? Imagine CRAs accessing and updating their trip report and site status information directly within Microsoft Outlook, even if they don't have Internet access and without ever connecting to the CTMS. As soon as this site report draft information is approved, the system automatically updates the CTMS with the appropriate changes. This is not the future. This is happening now.
Jennifer Price is Director of Clinical Solutions at BioClinica, Inc., 800 Adams Avenue, Audubon, PA, e-mail: Jennifer.Price@bioclinica.com.