With the technology available today, operational efficiency can be leveraged to speed up the labor intensive clinical trial process.
However, with the number of multiple efficient management systems, the integration can become so complicated that the efficiency benefit of leveraging that technology often is never fully realized. The solution for speeding up the clinical trial process and reaping all of the benefits of technology is a Clinical Trial Portal.
The term “portal”—often called “clinical trial portal” or CTP—is outrageously misused in our industry today. To clarify the term, I will define what constitutes a true portal and what is not a portal at all. The first clarification: web sites are not portals. Although portals are web-based, all web-based applications are not portals.
Clinical Trial Investigator Portals are tools that focus on facilitating sponsors’ recruitment and training of investigators, including the ongoing exchange of information and the completion of documentation with them during the lifecycle of a clinical study. Although the definitions, terminology and applications of portals still may be evolving, we can discern that portals have unique capabilities that allow customization, role-based views, document exchange and work flow applications.
Portals used specifically for clinical trials (CTP) serve as centralized ways to securely conduct information exchange and can deliver enormous efficiencies if set up and deployed properly. Although now typical to the conduct of many clinical studies, not all portals are equal and are used to their full advantage. To gain the full benefits of cycle-time efficiencies and a quality perspective, a portal should be used from the very first stages of feasibility through the reconciliation of the study data. A true portal also will be module-based and be able to integrate with existing clinical trial systems.
Portals are great communication vehicles, allowing consistent messaging across teams by providing a secure study workspace designed to encourage collaboration. A CTP should have the capability to show role-based dashboards. For example, a study start-up lead’s dashboard may show metrics on site activation, while a patient recruitment professional’s dashboard will show enrollment metrics. Having data pertinent to your role instantly enhances your ability to initiate outcomes.
The best CTPs have a secure document exchange component with eSignature functionality for contracts, budgets and other study documents that even can include electronic monitor trip reports. The CTP should encompass staff training, allowing access to the modules to accommodate staff changes and track certifications. True CTPs can be deployed at the study, program or enterprise level, and can be configured swiftly to meet additional needs of the changing regulatory landscape of global clinical trials.
So, do sites and sponsors like using portals to manage their programs? The “fitness of use” factor comes into play, which is a highly-referred-to term explaining the quality of web portals. Users often will rank their experience by general factors such as content, functionality and usability. The content on a portal must be relevant to the user, frequently updated and arranged in an aesthetically pleasing manner. Functionality matters to the users, and they desire a CTP that encompasses all of the workflow roles within it. For example, if the CTP does not allow electronic signatures and requires activities outside of the system, such as wet signatures, functionality is reduced and compliance may suffer as a result.
Usability also is important to users. Because portals are “gateways” to other information and systems, they need to be easy to use. Having “single sign on” (SSO) capabilities is one way to ensure your CTP has a high usability aspect. SSO is the mechanism of access control that allows one login to automatically sign you on to multiple software systems that are integrated or require the sharing of data. The impact of SSO is enormous, considering the average clinical trial requires access to between six and 10 systems. If usability suffers due to multiple passwords, you run the risk of diminishing the integrity of the data output derived from these systems.
Understanding the benefits and limitations of various CTP systems can help gain the maximum operational efficiencies to reduce study timelines and accelerate study start-up, site management/communication and patient recruitment.
Ashley Tointon directs patient engagement programs at ePharmaSolutions, combining traditional methods with innovative, data-driven techniques to provide sponsors high-impact, cost-effective recruitment and retention programs. She has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry.
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