Trial design and execution are increasingly put under the microscope as biopharma companies seek improved R&D proficiency. In today’s blog, Steve Glass, Group Managing Director, Clinigen, explores the challenges of comparator clinical trials in this quest for efficiency.
Over the last five years there has been a great deal of disruption and innovation in clinical trial management. As the biopharma industry accelerates development times and consolidates new product pipelines in a quest for improved R&D efficiency, it’s no surprise that trial design and execution has also been under scrutiny. Designing and managing an effective, secure and efficient comparator clinical trial can be challenging for many companies. To succeed, an understanding and adoption of new approaches, novel project planning, and strategic partnerships with specialist providers is vital.
One of the most important of these strategic partnerships is between companies running trials, and specialist medicinal product sourcing and material supply businesses like Clinigen Clinical Trial Services (CTS). Such expert providers enable the implementation of improvements and efficiencies, without compromising supply chain quality, compliance and integrity.
With the top 20 biopharma companies each spending US$75-100m per year on comparator drugs alone (a figure that is predicted to increase by 8% year on year), comparator drug supply is big business and needs to be done right.
Clinical research – An evolving landscape and drivers for change
A number of factors have necessitated a change in how clinical research is undertaken including pressure to streamline study execution and expedite results, innovative and complicated trial designs, a shift in patient recruitment to emerging markets and on-going patient recruitment and retention challenges.
As a result of these top level factors, the sourcing and distribution of trial supplies have been also been affected by specific challenges and newly emerging issues. These include:
- An increase in globally dispersed, multi-centre studies
- Escalating costs of active comparator drugs
- A more stringent and changing regulatory framework for study supply
- Growth of Randomisation and Trial Supply Management (RTSM) and Interactive Response Technology (IRT) systems
- A need to minimise shipping costs whilst ensuring security from falsified medicines and rigorous control of temperature
Change and disruption drive innovation
Many clinical trial supply partners like Clinigen CTS are working closely with bio-pharma companies and CROs to evolve new services, state-of-the-art facilities and partnerships to ensure Investigational Medical Products (IMP) and Non-Investigational Medical Products (NIMP), or comparator, sourcing and supply plays an integral part in driving new efficiencies, reducing wastage and maintaining quality.
Bio-pharma companies looking to partner with a strategic clinical trial supply business should carefully consider the following service requirements to ensure the most effective and secure comparator drug and ancillaries supply programme is provided:
- Technical consultancy and expertise – First and foremost comes understanding. Advice should be underpinned by proven experience and knowledge of the trial supply sector including the complex regulations and strategies for entire studies or programmes. A good partner has the capacity and flexibility to provide clients with extensive options, whilst always mitigating risks.
- Direct-to-site delivery – Comparator or ancillary drugs often need to reach patients at multiple trial sites quickly. A clinical trial supply partner must have both the global and regional distribution network to be able to rapidly procure and securely ship medicines; maximising the benefits of local, regional or centralised supply and saving time and money.
- Demand-Driven Labelling and Distribution (DDLD) – By operating on a ‘just-in-time’ basis clinical trial service providers can pool supplies, minimise the wastage of expensive material and maximise efficiency.
- Coordinated smart supply – It makes sense to synchronise the supply of allied requirements such as of ancillaries, standard-of-care medicines, co-medication and rescue medication for trials in one place. A good partner will support not only the supply of comparator drugs for a trial, but also a coordinated supply program for all essential components, removing the need to engage with multiple entities and providing greater compliance and reducing costs.
Whatever the challenges that you face in the rapidly evolving world of comparator drug and ancillary supply sourcing, strategic partnering means that you have an expert on hand to help you overcome them.
To learn more about comparator drug sourcing and clinical trial services visit http://www.clinigengroup.com/cts/our-approach
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