Tag Archives: Comparators

Case Study – Delivering Comparators for an Allergy Study

Request
CSI was asked to support a client trial for sourcing of grass pollen allergen tests. There were 2 main concerns:

1. No product was licensed in all countries where the trial was running
2. Quantities required were considerable and the Sponsor was worried about the availability of the required quantity in the timelines to support the trial The client wished to utilise the same product for all patients enrolled to ensure consistency in trial results.

The client wished to utilise the same product for all patients enrolled to ensure consistency in trial results.

CSI Approach
The Licensing aspect was clarified as the products are considered equivalent in literature, the composition was largely the same across products and the use of unlicensed products was common in many markets.

Due to the request for a large quantity of the same product the optimal sourcing strategy was a central model direct from a manufacturer. CSI decided the most pertinent option was to approach two independent manufacturers to protect the supply.

Challenges and Results
Using the evidence gathered by CSI on equivalency across products and the use of unlicensed medication the sponsor submitted with the two products to country regulators successfully.

Approaching two manufacturers was a prudent choice as when it came time to order the first choice could no longer support the quantity due to changes in production. The second-choice manufacturer was able to support the requested volume and the study ran to schedule.

Engaging CSI at the protocol design stage allowed the sponsor flexibility in sourcing strategy and provided a safety net with a backup option. The scientific expertise that CSI has was crucial in allowing the trial to follow a central sourcing model – minimizing risk of shortages in supply by only sourcing in one market.

Webinar – Comparator Sourcing in Clinical Trials: Complexities and Bespoke Solutions

Register for a Webinar hosted by CSI on Comparator Sourcing in Clinical Trials with Dr. Vanessa Dekou:

Comparator sourcing is a fast-growing industry in clinical trials that has doubled within the last five years. As most drug candidates are being studied against the existing standard of care (comparator), the need for secure and transparent sourcing of comparator drugs and non-investigational medicinal products (NIMPs) on a global scale is likely to rise significantly.

However, this is a very complex process and designing an efficient and agile supply chain is challenging. Often poorly designed supply chains result in tremendous wastage and even worse, lack of medication at the site might delay studies and put patients at risk.

There are many important questions to be addressed upfront; extensive planning and pharmaceutical supply knowledge on a global scale is required.

In this webinar, our speaker will provide a comprehensive overview of the complexities and challenges of sourcing comparators while addressing protocol requirements. She will also provide expert science-based advice on bespoke solutions for successful comparator sourcing.

Read more information about the webinar here:

https://xtalks.com/webinars/comparator-sourcing-in-clinical-trials-complexities-and-bespoke-solutions/

Whitepaper – Oncology Trials Comparator Sourcing

Comparator Sourcing for Oncology Trials – Current Trends and How to Safeguard Trial Progress

This is an exciting time for oncology trials, year on year record numbers of therapeutics are launched and the indications for many drugs on the market are increasing rapidly. Immunotherapies and next generation biotherapeutics are being approved for more tumour types and a growing percentage of the late stage oncology pipeline are targeted biologics.

However, with growth comes increased risk. Trials are more complex than ever, with more locations in new geographies and adaptive trials becoming more common. This complexity is affecting trial success rates which are routinely lower than other therapy areas. Post-trial oncology products also experience difficulty entering the market. Immunotherapies and next generation biotherapeutics may be the future of oncology but they are significantly more expensive than older non-specific therapies on the market.

Positive results from health technology assessments, used to inform purchasing decisions, are becoming less and less common in oncology as costs of therapies skyrocket and specificity

increases. For a clinical trial to demonstrate the added value of the IMP it is now essential that it is compared to the standard of care rather than a placebo.

This increases costs and therefore risks of a trial but is a necessary component for a novel therapies’ success. It is therefore imperative that a clinical trial is well managed and efficient with resources to minimise risks and ensure that the IMP goes to market positively.

There are some encouraging trends, biomarkers and selecting patients from prescreened pools have increased productivity of trials and lowered costs. Streamlining comparator sourcing is another strategy that can dramatically affect the efficacy of an oncology clinical trial.

Comparator selection is a vital component of a sourcing strategy. Using biosimilars or generics where available can decrease the cost of comparators in a trial by as much as 50%. However, this can be a complicated solution, licensing on biosimilars is dependent on proven pharmaceutical similarity to the reference drug, this can be different between markets potentially affecting the sourcing strategy.

Different sourcing strategies have positives and negatives, local sourcing can be an effective strategy for a small phase I trial in a handful of countries but can be very challenging in a global phase III trial spanning many countries and regulatory bodies. Regulatory complexity is compounded by logistical complexity, working with stakeholders across the globe to deliver products in a timely manner can be especially challenging. There is not a one fits all solution in comparator sourcing, it is therefore important that extensive research is undertaken to find a range of options. With CSI as a partner you will be receiving gold standard service to de-risk comparator supply in your clinical trial.

Whitepaper – Role of Comparators in Clinical Trial Designs

Introduction

The role of Comparators in Clinical Trials
Drug development is a very complex, long and expensive process. Once a suitable molecule is identified then clinical trials are undertaken to establish the effect of an intervention.

Treatment effects are efficiently isolated by controlling for bias and confounding and by minimizing variation. Key features of clinical trials that are used to meet this objective are randomization (possibly with stratification), adherence to intent-to-treat (ITT) principles, blinding, prospective evaluation, and use of a control group. Compared to other types of study designs (e.g., case-control studies, cohort studies, case reports), randomized trials have high validity but are more difficult and expensive to conduct.

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