Company insight
Decentralisation is here to stay
As part of the Thermo Fisher family, PPD is uniquely positioned to provide new, fit-for-purpose solutions to help sponsors create a better patient experience and realise the benefits of decentralised trials, all while ensuring studies yield high-quality data.
growth. With this model it is possible to conduct aspects of the trial remotely, supporting a better patient experience while still conducting the aspects that require in-person interactions at clinical trial sites. As new modalities and personalised medicines become an industry focal point, this shift to decentralisation represents an exciting evolution in the clinical trial landscape, with the potential to bring more lifesaving products to patients quicker. As hybrid trials prioritise patient centricity, they also have the potential to increase patient retention and reach those otherwise under-represented. The industry’s wider adoption of existing technologies and recent innovations has supported the growth of hybrid trials. To find ways to reduce patient burden without sacrificing data quality, technologies have been incorporated into new and evolving trial designs that include assessments through tele-visits – wearable devices that provide real-time patient data – and even reconsidered endpoints. The space continues to evolve rapidly at nearly every level. Building the foundational planning practices and adding real-time connections to clinical trial information improves the ability to respond to situations and mitigates risk throughout the clinical supply chain, ensuring material is available for patients when they need it.
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The broader industry push toward patient centricity is guided by the expectation that reduced patient burden – including regular travel to the clinical trial site – will lead to faster screening, recruitment, greater participation and retention. This will be highly beneficial in terms of increasing the diversity and representativeness of clinical
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ybrid trials combining a mixture of site-based and decentralised solutions are experiencing explosive
trials, a crucial and historically overlooked consideration. Overall, the hope is that decentralisation – with effective planning – will make it possible to implement clinical studies quicker and more cost-effective.
Significant opportunities for new trial designs
In support of increased patient centricity, pivoting from a preventive focus to the collection of adherence data could also provide deeper insights into patient behaviours. Such data can be used not only for their primary purpose, which is to confirm and/or maximise patient adherence, but also to ensure the timely provision of supply, improve future protocol designs and processes, and advance the procedures used to implement hybrid and fully decentralised studies. The biggest resistance to adoption of these adherence tracking technologies is they generate data that is very different from the passive methods used traditionally, namely diary entries and pill counts. It has been shown that the overestimation of drug exposure in most trials using existing methods is 15% over time compared with what is determined using passive adherence methods. That 15% is typically accounted for by adding more patients to trials. The implementation of comprehensive adherence techniques may make it possible to require fewer patients in trials in the near future, thus increasing speed and reducing costs.
Balancing participation and adherence Traditional site-based trials leverage designs to support patient adherence. In the most extreme cases, where a patient must receive treatment every day under direct observational therapy, 100% adherence can be consistently
achieved. For example, the success of early HIV treatments can be partially attributed to clinical trials with direct observational therapy. Today, this approach is used in developing countries for the treatment of tuberculosis and other infectious diseases that require strict regimens be followed. Achieving a level of successful adherence in decentralised or hybrid trial models requires new approaches to validate whether patients are participating as per protocol – taking their medications as prescribed, making self-observations, performing certain activities and so on – and help mitigate any potential uncertainty. New adherence measurement methods – for example, smart packaging combined with remote monitoring, including text messages containing alerts or phone calls made to participants – give investigators a deep understanding of how each patient is exposed to the study drug, providing confirmation that the patient is dosed correctly and managing some of the potential risks. Additionally, acquiring more information about specific dosing behavioural problems allows the sponsor and CROs to offer specific, not-too-intrusive interventions to patients to help correct them, and patients tend to be responsive to these tailored interventions. The right trial design and application of adherence technologies and techniques are among the solutions that can reduce or eliminate concerns surrounding perception of decentralisation and its fewer human touch points. Ultimately improving a patient’s exposure to the study drug in compliance with the protocol, these innovative adherence measurement solutions could be seen as an insurance policy. ●
www.thermofisher.com Clinical Trials Insight /
www.worldpharmaceuticals.net
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