It’s widely accepted now in the clinical research community that bringing a clinical program’s processes and systems together in a single platform is a good thing. So why is making this shift towards greater trial efficiency seemingly still out of reach?
On the surface, it’s a daunting change: drug development programs are no longer single studies, but expansive umbrella trials testing different combinations of the investigational agent in numerous indication and multiple countries (think: Keynote trials for immunotherapy).Pulling information from the different sites and systems involved in international programs of this scale, and ensuring that it complies with regulatory requirements, is no mean feat.
But the need is clear: more complex trials drawing from larger patient populations, and with many more stakeholders involved, require a more systematic and sophisticated approach to study management.
The problem, according to some, is that “the clinical trials site system, designed in another era, lacks the cohesiveness and resources necessary for sustained coordinated change.” What is needed, is “a more efficient clinical trial unit, with greater resources”.
This diagnosis for the industry was published five years ago. And yet “confusion and trepidation” appear to be holding back integration. So, what are the benefits, and what are the technical capabilities you should be looking for?
Why Integrate Your Clinical Systems and Data Sources?
Since the FDA opened the door to electronic data capture in clinical trials, the benefits of integrating clinical trials systems have been well documented. They include:
- Faster and more successful patient recruitment from integration with Electronic Health Records – which not only increases the number and diversity of your participant population, but can make recruitment more objective
- Rapid almost real-time analysis of trial progress – including timely alerts to recruitment and safety issues, allowing you to be proactive not reactive
- The ability to spot trends and patterns that would otherwise be impossible with incomplete data-sets or data being held in disparate systems
- Smooth and seamless regulatory submissions based on data that has already been quality-assured leading to speedy approvals
- Real-time and prospective risk and issue management – not only will timely access to data in a single system help you to change course in the current study, but will allow you to prevent the same issues in the next one
- A better trial experience for all stakeholders – by enabling stakeholders to manage and interact with information and each other through a single, universal platform, you can build that all important sense of study team
What Makes A Great Integrated Clinical Trials System?
Having decided that you want to bring these benefits to your clinical research programmes, what should you be looking for in the ideal integrated system?
At Longboat, we’ve asked a lot of people working on trials what they want from a clinical study management system. And combined with our many years’ experience working in clinical trial management, we believe a great clinical management system should:
- Be data-agnostic – a platform must be able to integrate data from any source (e.g. multiple IRT systems, internal sponsor databases) for it to truly solve the inefficiencies of data silos
- Use a flexible API so that all stakeholders can provide their information, ensuring completeness, robustness, and security of data
- Include functionality to track and audit data acquisition and study management actions
- Be interactive – allowing users to view data in their format of choice
- Be simple and intuitive – even if unfamiliar to the user
- Provide information tailored to suit each user’s needs
- Be easy to access from anywhere and available with any device (mobile, tablet, PC)
- Provide a slick, smooth user experience for study teams and patients alike
We believe data integration shouldn’t be a headache for the people it’s designed to help. So we developed Longboat’s platform to do just this. If you are looking to improve efficiency and reduce costs of your clinical trial management, these features should be high up on your list, too.