A decade of the Clinical Trials Transformation Initiative: What have we accomplished? What have we learned?

Tenaerts, Pamela; Madre, Leanne K.; Landray, Martin J

doi:10.1177/1740774518755053

Cited by 13 publications

(12 citation statements)

References 11 publications

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“…35 A number of initiatives, such as the Clinical Trials Transformation Initiative (CTTI) and the 'Sensible Guidelines' group, aim to simplify trial design and to address difficulties affecting current clinical trials in general, including international oncology trials. 36,37 The CTTI aims to improve efficiency and quality in clinical trials by providing evidence-based, consensus-Box 2. Cancer Breakthroughs 2020…”

Section: Initiatives For Improving Clinical Trialsmentioning

confidence: 99%

“… 35 A number of initiatives, such as the Clinical Trials Transformation Initiative (CTTI) and the ‘Sensible Guidelines’ group, aim to simplify trial design and to address difficulties affecting current clinical trials in general, including international oncology trials. 36 , 37 The CTTI aims to improve efficiency and quality in clinical trials by providing evidence-based, consensus-driven recommendations and resources to promote efficient, patient-centric clinical trials. 36 Examples of CTTI projects include the promotion of central institutional review boards for multicentre clinical trials, guidelines to optimise the conduct of data monitoring committees and tools to improve the quality and efficiency of safety reporting.…”

Section: Recommendationsmentioning

confidence: 99%

“… 36 , 37 The CTTI aims to improve efficiency and quality in clinical trials by providing evidence-based, consensus-driven recommendations and resources to promote efficient, patient-centric clinical trials. 36 Examples of CTTI projects include the promotion of central institutional review boards for multicentre clinical trials, guidelines to optimise the conduct of data monitoring committees and tools to improve the quality and efficiency of safety reporting. 38 Some of the CTTI recommendations are echoed by the policy report of the Working Group to Facilitate International Cooperation in Non-Commercial Clinical Trials convened by the Organisation for Economic Cooperation and Development (OECD) Global Science Forum.…”

Section: Recommendationsmentioning

confidence: 99%

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Challenges of international oncology trial collaboration—a call to action

et al. 2019

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International collaboration in oncology trials has the potential to enhance clinical trial activity by expediting the recruitment of large patient populations, testing treatments in diverse populations and facilitating the study of rare tumours or specific molecular subtypes. However, a number of challenges continue to hinder the efficient and productive conduct of both commercial and non-commercial international clinical trials. These challenges include complex and burdensome regulatory requirements, the high cost of conducting trials, and logistical challenges associated with ethics review, drug supply and biospecimen collection and management. We propose solutions to promote oncology trial collaboration, such as regulatory reform, harmonisation of trial initiation and management processes and greater recognition and funding of academic (non-commercial) clinical trials. It is only through coordinated effort and leadership from researchers, regulators and those responsible for health systems that the full potential of international trial collaboration can be realised.

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Section: Initiatives For Improving Clinical Trialsmentioning

confidence: 99%

Section: Recommendationsmentioning

confidence: 99%

Section: Recommendationsmentioning

confidence: 99%

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Challenges of international oncology trial collaboration—a call to action

et al. 2019

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“…RECOVERY benefited from the willingness of UK doctors to randomize unproven treatments (rather than, as in many other countries, obstructing randomization by incorporating unproven drugs into local practices and guidelines); strong national support from funders and the National Health Service; and the pre-existing UK clinical-trials network, which provided research nurses at recruiting centers 6 . RECOVERY's streamlined trial conduct and data collection 7 formulaic training on good clinical practice -enabled the participation of hospitals already stretched by patients with COVID-19, with many of the less-research-experienced hospitals being among the best recruiters. Finally, a strong letter of support from the Chief Medical Officers of England, Wales, Scotland and Northern Ireland emphasized that the trial was to be seen as part of clinical care and stated that "Use of treatments outside of a trial, where participation was possible, is a wasted opportunity to create information that will benefit others. "…”

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confidence: 99%

COVID-19 clinical trials: learning from exceptions in the research chaos

Tikkinen

Malekzadeh

Schlegel

et al. 2020

Nat Med

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, Director of Wellcome and Chair of the World Health Organization R&D Blueprint Scientific Advisory Group, has said "It's critical that the global research effort is rapid, robust and is conducted at scale and coordinated across multiple countries. " Of the >2,000 planned drug studies examining COVID-19 treatments (https:// www.covid-trials.org), most have delivered little or no directly useful information 1. Exceptions include two large, adaptive, pragmatic trials, RECOVERY and SOLIDARITY, which combined have randomized >20,000 patients to assess the effects of several treatments on mortality 2 , and the US National Institutes of Health ACTT trial, which randomized 1,059 patients to assess the effect of remdesivir on time to disease resolution 3. The speed of the RECOVERY trial (https://www.recoverytrial.net/files/ recovery-protocol-v7-0-2020-06-18.pdf) was record-breaking: the period from protocol to first patient recruitment was nine days, with the 176 UK hospitals recruiting >12,000 hospitalized patients (15% UK COVID-19 cases), and it provided clear answers within a few months on the effectiveness of dexamethasone 2 and the ineffectiveness of hydroxychloroquine and lopinavirritonavir (Fig. 1). Notably, it sought to achieve reliability and quality by design rather than by compliance with good clinical practice or site monitors, relying instead on centralized computer checks on site behavior and patient compliance, and utilizing central National Health Service medical records of treatment and outcome. Also, it did not necessarily require written consent where the medical emergency rendered this inappropriate. The World Health Organization-led SOLIDARITY trial (https://www.who.int/ emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments) has recruited >9,000 patients across 30 countries and is currently recruiting about 2,000 patients a month. SOLIDARITY has also provided important evidence on the ineffectiveness of hydroxychloroquine and lopinavirritonavir and is the largest trial examining the effects of remdesivir and interferon on

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“…Tenaerts and colleagues cite advances in e-consent, such videos or dual channels that combine visuals with voiceover, followed by quizzes as some of the most striking improvements in clinical trial consent over the past decade. 32 The Food and Drug Administration has published guidance on the use of e-consent in clinical studies, including clinical trials. 33 Some platforms allow for electronically signing and enrolling in trials, which can be an added benefit.…”

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confidence: 99%