Adapting for Adaptive Clinical Trial Designs

Adaptive designs feel like they have been around for ages with multi-cohort studies/registries, multiple patient populations in single studies, pediatric assent/consent cohort models and more. Although they feel familiar, biopharma sponsors are requesting these study designs at a significantly increased rate this year. Part of this increase may be influenced by FDA's draft guidance on master protocols including the revision in 2026 adding more context on the overall solution and basket trials.

Similar to digital health technologies (DHT), THREAD is experiencing this measurable increase in Adaptive Clinical Trials this year via these study designs:

• Basket trials: testing one therapy across multiple diseases
• Umbrella trials: testing multiple therapies within one disease
• Multi-arm studies: including several treatment groups in a single protocol

Now that Adaptive Clinical Trial designs are increasing, we have an opportunity to not repeat the familiar patterns in adapting our solutions

The Familiar Pattern

I've spent nearly 25 years in clinical research. In these decades, I have seen a similar pattern occur when new study designs were selected. This is obviouslynotan all-inclusive list but below is how I would summarize the pattern:

1. Clinical trial study team recognizes the change and starts making it
2. First study that will adapt to the design change is selected
3. Initial thoughts and questions(first time working through them usually)on the revised design are asked to partners in the selection process
4. Study team and technology partners team up to adopt the new approach based on what they know at this stage
5. Adoption model is discussed but not yet ready and being constructed in parallel to the first study implementation
6. The technology platform and features get outpaced by the new requirements as they are identified in the startup process
7. Manual processes and "work arounds" are aligned to cover the gaps and keep the startup process moving forward to acheive timelines
8. Study design launches without every functionality the technology could offer and requires additional effort (in an already complex and new design) to ensure the study patients, research sites and study team members are best supported
9. Study teams (and their partners) adapt in real-time as best as possible. Research sites maneuver through "work arounds," changes and re-training. Patients require additional support and follow-up. The study works but isnotsmooth like everyone expects it to be with all the attention on a new design.
10. Next study feels significantly more simple compared to the first with the experience, processes and technology features now achieving a best case scenario in sync with each other

I recognize that your experience may be slightly better, different or worse but this is in the ballpark of the pattern you experienced, right?

Don't Repeat the Familiar Pattern in Adaptive Trials

After supporting several Adaptive Clinical Trial designs over the last couple of years, we had a great opportunity to work closely with research sites, patient organizations, biopharma sponsors and CROs to address every identified technology "gap" to shift these studies from complex to smooth for everyone. We had to adapt our technology to meet these needs and ensure we could before we made it public.

After launching the next five (5) most recent Adaptive Trials, we were able to test that we had achieved this goal with positive feedback from study stakeholders. After that confirmation in JUL 2026, we announced our new platform features to specifically support Adaptive Clinical Trial designs.

We specifically released these features tonotrepeat the familiar pattern and provide the smoothest technology process we could co-develop to achieve this goal. The new platform enhancement enables research teams to manage multiple participant pathways, indications, and workflows within a single study platform, app and configuration.

This new configurable technology feature helps study teams reduce setup timelines, simplify protocol amendments, and lower operational costs with greater flexibility for adaptive clinical trial designs. Sponsors and CROs can utilize this feature seamlessly within THREAD's participant app, version management capabilities, and role-based access controls, creating an instantly configurable solution for complex study designs for the following benefits:

• Faster study setup and rapid protocol amendment adjustments
• Dynamic participant pathways that adapt to individual study requirements
• Greater governance with role-based controls for participant transitions between cohorts
• More seamless participant experiences through automated task and visit management

I am so proud of the collective team that worked together to make this happen and have this available to configure today to defend against this familiar pattern.

Designing Your Adaptive Clinical Trial

If you are currently designing (or planning to design) your next Adaptive Clinical Trial(s), let's connect for a few minutes.

We would be happy to share lessons learned and show you live how our platform is not repeating the usual pattern you want to avoid in your next study.

Please direct message me or send an email tosales@threadresearch.comto schedule a session with our expert team.