From trial to treatment: speeding up drug development during a global pandemic
When developing potential treatments or vaccines for a global pandemic, time is of the essence. Delays can be incurred at many points throughout the development pathway, and it is important
that these are carefully managed to facilitate speedy development and availability of new therapies.
Clinical trial design and reporting
A number of strategies can help to reduce the time it takes to complete a clinical trial.
Platform trials/modular protocols are designed to evaluate many treatments within the same protocol, thus improving the likelihood of finding an effective treatment. Ideally, these studies should include an adaptive design, which allows continual modifications to the trial design during data collection, to improve the chances that the results will be clinically relevant. Adaptive protocol design can also reduce resource utilisation and time to completion, as well as ensuring that fewer patients are exposed to inferior treatments. To ensure consistent outputs across the different protocols, it is essential to have a standard process with an effective rollout of any adaptations to all participating sites.
Innovative methods of data collection can help to improve the speed and efficiency of a clinical trial, particularly under lockdown conditions. Our clients are implementing a range of measures from digital solutions, such as eDiaries for patient-reported outcomes, to home visits for blood collection and other physical measurements. Procedures for remote study management are also being developed, including site qualification, initiation, monitoring and termination.
Unsurprisingly, there has been an explosion of new clinical trials to assess a range of treatments in the fight against COVID-19. By early July, over 1,300 interventional studies had been registered on the clinicaltrials.gov website. Therefore, competition for patients is likely to be high, particularly in the many countries worldwide that have been successful in limiting infection rates. To mitigate this, Barts Health NHS Trust have developed a co-enrolment framework to support recruitment of individual patients to more than one COVID-19 research study; this will be rolled out across England and Wales. For pharmaceutical companies trying to recruit to their own studies, clear and timely communication will be needed for both physicians and patients. Training for study teams on how to communicate with patients remotely should also be considered.
To help get new treatments to patients as quickly as possible, the US FDA has launched a Coronavirus Treatment Acceleration Program, which aims to provide fast and interactive input into trial development plans, prioritised based on a triage system depending on the scientific merit of each proposal. In the EU, PRIME applications allow more regular access to the EMA to facilitate rapid
review of submissions. On a positive note, changes made during this pandemic may lead to permanent changes to FDA procedures, which could continue to provide accelerated drug development in the future.
Rapid communication of the trial data to the global community is critical. An experienced publications agency can support rapid publication through close liaison with all stakeholders, providing recommendations for target journals, high-quality writing and robust tracking to ensure that a manuscript is developed quickly while remaining compliant with Good Publication Practice. Many publishers are putting policies in place to fast-track COVID publications, and some such as Elsevier are making coronavirus information freely available. It is also worth noting that ISMPP has provided temporary guidance on authorship to address issues of non-responsiveness due to the coronavirus pandemic.
Making data immediately available before final publication can be achieved by posting to one of the scientific preprint servers such as bioRxiv. This also enables the authors to receive early feedback on draft manuscripts, even before they are submitted to journals. However, it is worth bearing in mind that some journals may not accept papers previously uploaded to a preprint server. Working with a single vendor, such as Bioscript, who can support across all these elements, can help the process run smoothly, reducing delays, avoiding miscommunication and delivering a consistent message to all audiences.
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