Clinical trials are moving faster than ever, and decisions about starting, stopping, continuing or changing protocols are happening in real time, across geographies. It is critical to have a digital home that centralizes, simplifies and automates all of the crucial information, processes and tracking that can significantly impact the course of a program.
Conventional trial design and oversight has been pushed to evolve and change in the two years since the FDA first released their “Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry,” and the Covid-19 pandemic has only hastened the shift, pushing adaptive trial design to the fore.
As adaptive trial design emerges as part of the new normal, clinical trial oversight design must embrace smarter software like Cloud Concinnity® to adapt and thrive.
Adaptive trial design takes clinical research to the next level, yet it presents some key challenges that come with speed and responsiveness. Challenges and demands like 1) More Meetings, 2) More Decisions, 3) Tighter Timeframes, 4) More Complex Data, 5) More Data Streams and 6) Higher Stakes come part and parcel with adaptive trial design.
For oversight teams, smarter software holds the key to addressing and solving many of these challenges. Here’s how:
6 Ways Smarter Oversight Software Meets the Demands of Adaptive Trial Design
1. More Meetings? Smarter Software Means Better Process Automation
Adaptive trial design means more data and more decisions to make — and that means more meetings to discuss and make those decisions. With an oversight team spread out across the world and across time zones, manually managing standard operating procedures and charter mandates can create significant delays. Using a platform that automates meeting management end to end gives administrators broad and deep capabilities like automated scheduling, invites, reminders, data aggregation and decision documentation making less work for everyone, and more time for deep thinking.
2. More Decisions? Smarter Software Lets You Stay Connected, Secure & Well-Informed
The data, information and consideration it takes to successfully oversee and manage an adaptive trial means lots of reading and questions. Every bit of that information must be kept confidential, which is easy with smart software that has the most advanced security protocols. What’s more, smart software can keep all communication during the decision-making process secure, so there’s no need to risk email, text, or video chats that could be hacked or leaked.
3. Tighter Timeframes? Smarter Software Centralizes & Streamlines Everything
We know that “Adaptive clinical trials can be completed sooner than trials with conventional (non-adaptive) designs,” so there is every reason to expect this faster, more nimble trial design to be widely adopted. And with the potential for speed comes tighter timeframes. Centralizing access, process, and outcomes means everyone on the oversight team need only check and stay updated on a single platform. Centralized means simpler, and simpler means faster. In addition, getting together as a team simultaneously to discuss everything, every time can be unrealistic. That’s why the secure, asynchronous communication that smarter software offers is critical. Share documents, have conversations and send messages across time zones and geographies.
4. More Complex Data? Smarter Software Simplifies Everything with a Master Dashboard
Adaptive trials deal with and generate more complex data than conventional ones. That means more reading and more digesting, but it doesn’t change the fact that we all need a way to get a sense of things at a glance. A single, secure hub for the aggregation, review and submission of data for oversight committees, sponsors & regulators makes that possible with a master dashboard and analytics. Customizable, global dashboards that aggregate key information within and across studies gives unprecedented visibility to key study results and metrics 24x7.
5. More Data Streams? Smarter Software Offers Powerful Data Integration
Adaptive trial design means more data streams, more information, and more decisions to make. A platform that is integrated across the eclinical ecosystem ensures data integrity from trial planning all the way through regulatory approval and beyond. Confidently create a single source of truth for your trial oversight activities that securely connects all points of information, from EDC to eTMF.
6. Higher Stakes? Smarter Software Delivers End to End Process Management
“Unlike conventional designs, where the learning typically occurs after the trial is completed, adaptive designs intend for continual learning as the data accumulate.” Continual learning and adaptive decision-making means more to manage, and that’s why the process management engine of smarter software is so critical. End to end process management is the ideal vehicle to power continual learning for a dispersed oversight team.
In the end, it’s clear that adaptive trial design is the way of the future, which means oversight teams will need to be more adaptive as well. Smart software is the only answer that lets teams step up to the next level while also maintaining or improving quality.