A recent poll conducted by ClinPhone showed that over 60% of responders are either currently implementing or considering implementing adaptive trials
The opinion poll of over 500 participants was part of ClinPhone's educational and interactive webinar series titled "Applications in adaptive trial designs", delivered in collaboration with Cytel , a provider of clinical trial consulting services.
The results show that the adoption of adaptive techniques is gaining rapid momentum due to their major benefits including effective selection of optimal dose, accelerating decision making and shortening drug development timeline.
Adaptive trials are studies that use accumulating clinical response data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.
Although the use of interim analyses is not new, the option to make design modifications within a formal framework accepted by regulators is a new development.
The webinar highlighted that successful implementation of such designs requires selection of optimal methodology based on sound statistical input, robust trial simulation capability and rapid access to on-going study data.
Graham Nicholls, product manager at ClinPhone, comments: "We received an overwhelming response to this webinar topic - with over 500 people attending the event.
"The response underscores sponsors' keen interest in ClinPhone's advances in adaptive trials and thought leadership at the forefront of technology developments.
"Technology plays a central role in delivering these types of studies, and ClinPhone is leading the way in offering integrated solutions to deliver enhanced functionality required by these complex designs".
Sponsors face a number of unique challenges when implementing an adaptive trial.
They include having to rapidly adjust the randomisation procedure to reflect adaptations, making speedy adjustments to medication supply chain as a result of such changes, and estimating clinical supply needs before and during the study.
ClinPhone claims an unrivalled wealth of experience in providing cutting-edge technology solutions to enable sponsors to overcome each of these challenges.
ClinPhone's experience covers all of the major types of adaptive trials including studies involving response adaptive designs, dropping of a treatment arm or dose, adaptive cohort analysis and sample size modifications.
ClinPhone's flexible and integrated technology solutions in randomization, trial supply management, EDC and ePRO provide the essential building blocks for effective and successful adaptive trial implementation.
ClinPhone's suite of solutions have supported over 75 protocols with design adaptations, helping sponsors achieve time and cost savings while maintaining regulatory standards.
