How Cancer Research UK is adapting to adaptive designs

Hearn, Julie; Keat, Nicola; Law, Kody J. H.; Sharpe, Rowena

doi:10.1186/1745-6215-12-s1-a6

Cited by 3 publications

(2 citation statements)

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“…Through collaborative dialogue with the funding committee’s Chair and Research Manager, a process was developed introducing a specific amendment form for new comparisons. There is now potential for review of amendments between meetings (‘out-of-committee review’) where funding is not requested, which can greatly reduce review timelines [12].…”

Section: Resultsmentioning

confidence: 99%

This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols

Schiavone

Bathia

Letchemanan

et al. 2019

Trials

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Background There are limited research and literature on the trial management challenges encountered in running adaptive platform trials. This trial design allows both (1) the seamless addition of new research comparisons when compelling clinical and scientific research questions emerge, and (2) early stopping of accrual to individual comparisons that do not show sufficient activity without affecting other active comparisons. Adaptive platform design trials also offer many potential benefits over traditional trials, from faster time to accrual to contemporaneously recruiting multiple research comparisons, added flexibility to focus on more promising research comparisons via pre-planned interim analyses and potentially shorter time to primary results. We share here our experiences from a trial management perspective, highlighting the challenges and successes. Methods We evaluated the operational aspects of making changes to these adaptive platform trials and identified both common and trial-specific challenges. The operational steps and challenges linked to both the addition of new research comparisons and stopping recruitment following pre-planned interim analysis were considered in our evaluation. Results Specific operational challenges in these adaptive platform protocols, additional to those in traditional two-arm trials, were identified. Key lessons are presented describing some of the solutions and considerations over conducting these trials. Careful consideration on the practicality of the protocol structure (modular versus single protocol), the longevity and continuity of trial oversight committees, and having clear clinical and scientific criteria for the addition of new research comparisons were identified as some of the most common challenges. Conclusions Understanding the operational complexities associated with running adaptive platform protocols is paramount for their conduct, adaptive platform trials offer an efficient model to run randomised controlled trials and we are continuing to work to reduce further the effort required from an operational perspective. Trial registration FOCUS4: ISRCTN Registry, ISRCTN90061546 . Registered on 16 October 2013. STAMPEDE: ISRCTN Registry, ISRCTN78818544 . Registered on 2 February 2004.

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Section: Resultsmentioning

confidence: 99%

This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols

Schiavone

Bathia

Letchemanan

et al. 2019

Trials

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“… 31 To address this, there are multiple strategies for, such using as a Bayesian posterior predictive approach, 32 or using complex innovative design, 33 a novel multi-arm, multi-stage (MAMS) design. 34 Hearn et al 35 discussed in depth this issue highlighting the need for decision-makers to avoid adopting entrenched positions about the nature of the trial design.…”

Section: Discussionmentioning

confidence: 99%

Clinical Trials of Liposomes in Children’s Anticancer Therapy: A Comprehensive Analysis of Trials Registered on ClinicalTrials.gov

Feng¹,

Gu²,

Yuan³

et al. 2022

IJN

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Objective Clinical trials have become essential for driving the development of medicine. However, little is known about the current status of clinical trials on liposomes in children’s anticancer therapy (LCAT). This study aimed to synthesize current finding from clinical trials of LCAT in ClinicalTrials.gov. Methods A cross-sectional descriptive study of clinical trials on LCAT was conducted, using studies registered on ClinicalTrials.gov through December 30, 2021. Results A total of 74 eligible trials were identified, accounting for 4.8% (74/1552) of all trials on liposomes for cancer therapy. Among these trials, 70 (94.6%) were interventional trials, and the remaining 4 (5.4%) were observational trials. Of the 70 interventional trials, 63 (90.0%) were for treatment, 48.6% were involving unlabeled allocations, 30.0% were randomized, 52.9% were single group assignment, 71.4% were without masking, 28.6% were Phase 3 trials, 30.0% were Phase 1 trials, and 24.3% were Phase 2 trials. Furthermore, 17 liposomal drugs for 123 types of cancer were investigated in the interventional trials, and these were mainly focused on organic chemicals (43/70, 61.4%). Of these cancers, the highest proportion was leukemia (15.4%), followed by lymphoma (9.8%) and ovarian cancer (8.9%). Conclusion High quality, adequately powered, masked, appropriately sized, and randomized clinical trials represent the critical priorities for conducting a high-quality clinical trial. However, most of these trials for LCAT were non-randomized, single group assignment, and non-blinded interventional trials of small scale, with various eligibility criteria and outcome measures. Our analysis highlights the need for improvement in the completeness of study designs curated on clinicalTrials.gov. We urge for decision-makers to avoid adopting entrenched positions about the study design of cancer clinical trials to avoid this problem. As such, tackling the problematic challenges related to cancer and designing efficient trials for cancer requires developing and applying new approaches and multiple strategies.

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