2021 brought with it many healthcare advances – the most monumental being the availability of numerous COVID vaccines to bring an end to the global pandemic. The year also brought many other advances, and opportunities for life science professionals to stay up to date on the research, technologies, and processes that are driving change in how new medical treatments are developed and ultimately approved for worldwide use.

So here, in case you missed them, are the ten most downloaded articles, white papers, webinars and more produced by Calyx scientific, technical, and regulatory experts last year. Each provides direction and perspective on optimizing and accelerating the clinical development and approval of medical treatments. We hope you find them as insightful and valuable to you now as they were the first time around.

Behind the Breakthrough

When breakthrough therapy designation is granted, the challenges of clinical trial imaging increase. This white paper presents an insider’s view of what happens when the stakes, scrutiny, and demands of clinical trial imaging are sky-high, to help you get medical imaging done right in your accelerated trial.

While Direct-to-Patient (DtP)shipping offers potential advantages in improving clinical trial patient engagement, this approach is not as simple as it sounds. This article from International Clinical Trials outlines the pros, cons, and factors to consider when designing decentralized or hybrid clinical trials that include a DtP approach.

Focusing on the use of PET and addressing key problem areas in response assessment seen frequently in clinical trial settings, this virtual panel of IMWG 2016 authors and imaging experts answered questions about optimizing imaging-related assessments in multiple myeloma trials and shared their expertise in imaging as well as the clinical parameters in myeloma response assessment for running successful myeloma trials.

Listen in and learn how clinical trial management systems can adapt to support positive industry changes, including advances in user interfaces, integrations, and the ability to use CTMS as a data hub to better surface clinical trial risks.

Calyx’s Craig Mooney reflects on recent changes in the regulatory landscape that emphasize the investigative site’s ownership of IRT data collected during clinical trials, and considerations for making progress toward this goal.

Regulatory publishing is the backbone of any pharmaceutical, biotech, or medical device business. Do you know what needs to be considered as you bring publishing activities in-house? This guide outlines everything you need to know.

What biomarker to target? Is Blinded Independent Central Review necessary? Should we ‘Collect & Hold’? In this live panel, Calyx medical imaging experts answered questions about how to succeed in early phase oncology.

You won’t want to miss this episode of the Calyx Cafe where our host explains how AI can benefit randomization and trial supply management processes. You’ll never believe who’s asking the questions!

Learn how to prevent data variability and potential clinical trial delays by normalizing local labs data with advanced EDC systems.

Understand the various factors that drive drug wastage in clinical trials and the different IRT approaches that can be used to reduce each in this ultimate guide.

In advance of his presentation at the Global Clinical Supplies Group Conference, Calyx’s Sylvain Berthelot reviews how effective IRT solutions can have a big impact on reducing drug wastage for more efficient and cost-effective clinical trials.

Introduction 

A large proportion of the cost of implementing a clinical trial is attributable to the production and management of medication. Over the past 25 years we have seen the management of medication in clinical trials move from a manual process to automated algorithms and workflows, leveraging IRT for Randomization and Trial Supply Management (RTSM) functionalities.

As IRT usage became more widely included, even in non-randomized and open-label clinical trials, it became a support for drug wastage reduction. By automating the trial supply chain, the available medication is directed to sites that are actively recruiting or treating subjects, thus ensuring those sites have sufficient stock to supply their subjects, while at the same time limiting the quantity of medication wasted by overstocking unproductive sites.

Here, we present a backgrounder on how effective IRT solutions can have a big impact on reducing drug wastage for more efficient and cost-effective clinical trials.

“What we intend to do by reducing waste in a clinical trial is identify methods upfront to reduce the quantity of drug that needs to be manufactured, stored and shipped to sites.”

– Sylvain Berthelot, Calyx

Defining drug wastage

It is important to define what we mean by drug wastage, as not all kits unused by the end of a trial have been wasted. In double-blind clinical trials, where sites and patients do not know which treatment is being dispensed, kits part of the site’s stock are needed to perform medication checks that are required to remove the risk of unblinding and to ensure randomization can be performed. It is worth noting that these kits are not wasted, as randomization or dispensing would not occur without the presence of all kit types at site, even in random scenarios where all patients at one site are part of the same treatment group.

Situations increasing drug wastage

Some trials will be more prone to increased drug wastage than others. For example, a single-country trial with only a handful of sites will result in less waste than multi-country trials supported by a complex supply chain. It is also worth noting that trials where kits are inexpensive will not require specific focus on waste reduction, as other supply chain factors will be more expensive than the drug cost such as cost of shipments.

Trials where we tend to see the most drug wastage include those with a lot of treatment arms, where the need to have medication suitable for all treatment arms at site is a source of waste. Trials where the same drug can have multiple formulations, or several dosing options may also be subject to a consequent amount of waste.

Click here for a quick glance at the various factors that drive drug wastage and the different IRT approaches that can be used to reduce each.

Proven IRT approaches to reducing drug waste

Most trial supply managers are familiar with the common supply scheme methods of Buffer, Trigger Resupply, and Prediction. These enable us to prepare for events that we can’t predict, such as new patients randomized/enrolled or kit replacement. And once subjects are randomized and in the IRT system, these approaches take advantage of knowing visit schedules and what medication is needed for dispensing visits, which optimizes study drug in a way that’s expected.

Supply schemes in IRT, the tip of the iceberg

Drug-Waste-Iceberg2

But these commonly used waste reduction approaches are just the tip of the iceberg. Underneath the water line, IRT provides additional options such as Fractional Prediction, Automated Supply Scheme Management, Rand Code Lookahead, and many others (figure 1). Each has different applications in reducing drug wastage based on different protocol designs, supply chain structure, and complexities.

Figure 1: The optimal IRT approach for reducing drug wastage depends on protocol design, supply chain structure, and complexity

Conclusion

Today’s IRT solutions offer numerous approaches to reducing drug wastage during clinical trials. To fully realize the positive impact those solutions have on drug wastage, sponsors should understand how they affect their manufacturing quantities during the trial planning. Otherwise medication is wasted at the central depot if already labelled for the protocol.

In the future, we expect additional ways to reduce wastage by expanding the use of just in time labelling. The emergence of smart packaging also provides more flexibility to clinical supplies management, simplifying medication pooling with the potential to adapt the label up to the time of dispensing.

COVID-19 pushed many companies to adjust their trial supply management approaches to keep their clinical trials on track during the pandemic.

Pharmaceutical Technology recently spoke with Calyx’s Sylvain Berthelot about the impact COVID has had on clinical trials, how the industry is approaching randomization and trial supply management now, and what we can expect as we move toward a post-pandemic world.

You can read the full article at the link below:

Necessity Drives Just-in-Time Approaches to Clinical Trial Supply

Media Contact:

Christine Tobin | [email protected] |+1 412-628-8598

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