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Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial.

ABSTRACT: Advances in 'omics' technology and targeted therapeutic molecules are together driving the incorporation of molecular-based diagnostics into the care of patients with cancer. There is an urgent need to assess the efficacy of therapy determined by molecular matching of patients with particular targeted therapies. WINTHER is a clinical trial that uses cutting edge genomic and transcriptomic assays to guide treatment decisions. Through the lens of this ambitious multinational trial (five countries, six sites) coordinated by the Worldwide Innovative Networking Consortium for personalized cancer therapy, we discovered key challenges in initiation and conduct of a prospective, omically driven study. To date, the time from study concept to activation has varied between 19 months at Gustave Roussy Cancer Campus in France to 30 months at the Segal Cancer Center, McGill University (Canada). It took 3+ years to be able to activate US sites due to national regulatory hurdles. Access to medications proposed by the molecular analysis remains a major challenge, since their availability through active clinical trials is highly variable over time within sites and across the network. Rules regarding the off-label use of drugs, or drugs not yet approved at all in some countries, pose a further challenge, and many biopharmaceutical companies lack a simple internal mechanism to supply the drugs even if they wish to do so. These various obstacles should be addressed to test and then implement precision medicine in cancer.

SUBMITTER: Rodon J

PROVIDER: S-EPMC5006164 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial.

Rodon J J Soria J C JC Berger R R Batist G G Tsimberidou A A Bresson C C Lee J J JJ Rubin E E Onn A A Schilsky R L RL Miller W H WH Eggermont A M AM Mendelsohn J J Lazar V V Kurzrock R R

Annals of oncology : official journal of the European Society for Medical Oncology 20150423 8

Advances in 'omics' technology and targeted therapeutic molecules are together driving the incorporation of molecular-based diagnostics into the care of patients with cancer. There is an urgent need to assess the efficacy of therapy determined by molecular matching of patients with particular targeted therapies. WINTHER is a clinical trial that uses cutting edge genomic and transcriptomic assays to guide treatment decisions. Through the lens of this ambitious multinational trial (five countries, ...[more]

PMID: 25908602

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Project description:BackgroundTrials in pre-hospital trauma care are relatively uncommon. There are logistical and methodological challenges related to designing and delivering trials in this setting. Previous studies have assessed challenges reported in individual trials rather than across the pre-hospital trial landscape to identify over-arching factors. The aim of this study was to investigate the challenges and opportunities related to the set-up, design and conduct of pre-hospital trauma trials from across the pre-hospital trial landscape and a specific pre-hospital trauma feasibility study.MethodsSemi-structured interviews were conducted with two cohorts of participants: research personnel who had experience of pre-hospital trials, either through direct involvement in conduct or through strategic oversight of national initiatives (n = 7), and clinical staff (n = 16) involved in recruitment to a pre-hospital trauma feasibility study. Thematic analyses were used to assess the barriers and enablers of conducting pre-hospital trauma trials. Two frameworks (The Capability Opportunity Motivation-Behaviour and the Theoretical Domains Framework) were used to guide analyses.ResultsThe barriers and enablers reported were relevant to several TDF domains and COM-B components. Across both cohorts, challenges associated with opportunities were reported and included the lack of research experience amongst pre-hospital staff, team dynamics within a rotating shift schedule, and the involvement of external organisations with diverse institutional priorities and infrastructures (e.g. Air Ambulances). The infrequency of eligible cases was also reported to affect the trial design, set-up, and conduct. Other barriers reported related to clinical equipoise amongst staff and institutional pressures, which affected motivation.ConclusionsThis study has highlighted that pre-hospital trials face many context-specific but also generic challenges. Pre-hospital trauma trial teams could consider the findings to develop targeted, behaviourally focused, solutions to the challenges identified in order to enhance the set-up and conduct of trials in this setting.Trial registrationNCT04145271. Trial registration date: October 30, 2019. Note that this paper does not report results from a specific trial but does include participants who were involved in the conduct of a registered pre-hospital feasibility study.

Dataset Information

Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial.

Publications

Challenges in initiating and conducting personalized cancer therapy trials: perspectives from WINTHER, a Worldwide Innovative Network (WIN) Consortium trial.

Similar Datasets

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