Inceptua’s Edoardo Madussi shares his insights on how to overcome the challenges of multi-country clinical trials
The case in favour of running a global clinical trial is compelling: lower running costs, quicker timelines, and access to substantially larger patient populations all contribute to a more efficient drug development process. But running a multi-country trial is a complex undertaking. With an enormous number of variables at play, seemingly minor delays can create a knock-on effect which sends costs soaring and timelines completely out of whack. How can pharma companies reap the benefits of a global trial whilst ensuring patients are safe, and increasingly stringent waste and cost reduction targets are met?
Regional differences make planning for a multi-country study challenging and, without local staff on the ground, it’s hard for companies to get a clear picture of the requirements they need to meet and the possible pitfalls they may face. From the design stage, working with a partner who can advise on the challenges of designing an agile trial that takes account of local variations in availability of materials, regulatory requirements, and possible logistic challenges is critical.
“We have an extremely multi-national team with a huge range of languages spoken,” says Edoardo Madussi, commercial director of the Clinical Trial Services division at Inceptua, “and this is a massive support for the sponsors we work with. Often, sponsors can see the opportunities offered by conducting a trial in an emerging market but the challenges they face in trying to operate in that market seem too great. Partnering with Inceptua gives them the support of our locally based teams who can give them the insight they need to build a robust plan for their trial.”
Establishing what the opportunities and options are within a local market is the first challenge for clinical trial planners. The range of clinical supplies available locally, and what the regulations are around clinical trials, can vary significantly between markets and to have an understanding of this in the planning stage is important. Where sponsors do not have this knowledge in house, working with the correct partner can help reduce the time from study conception to implementation, thus avoiding snowballing costs.
Further on in the planning stage, finding a sourcing strategy to ensure that the necessary clinical supplies are available can be a particularly acute headache for clinical trial project teams. With the cost of drugs rising dramatically in recent years, clinical supplies have become one of the largest components in the total cost of a trial. Increasingly, many sponsors need an external partner to help them establish a sourcing strategy which is both robust and cost effective. Inceptua’s strategic procurement team have significant experience of working with sponsors in the early stages of trials to establish the best sourcing strategy for a specific trial. A number of factors may influence the decision, including local regulations, availability, and cost.
“Our team is able to advise on solutions which will give trials a better guarantee of continued supply, meaning the possible disruption to patients is minimal.” says Madussi. “We also ensure sourcing is done either directly through manufacturers or with trusted nominated distributors, giving clearer transparency of supply chains and minimising risk to patients.”
Considerable advancements in technology and changes in regulation mean the clinical trial landscape is always evolving, but the need for securely sourced and correctly handled clinical supplies is a fundamental aspect that clinical trial project teams cannot overlook. Having the input of an experienced sourcing partner who can guide project teams, and help them ensure they are finding solutions which will work in practice is critical to the successful delivery of a trial.
Once clinical trial teams have their plans in place, the patients have been recruited, and the trial sites made ready, it is critical to have support with warehousing and distribution to ensure the ready availability of clinical supplies to the trial sites.
In many emerging markets, finding appropriate warehousing facilities to store clinical supplies, and transport solutions to be able to ship them in a controlled manner to the correct trial site can be difficult. Without a footprint of their own to rely on, sponsors need a partner who can provide this support. Inceptua’s GDP standard warehousing and distribution partners give sponsors access to a secure network of facilities, along with the local regulatory knowledge to ensure clinical supplies are being handled in accordance with best practice, whilst ensuring local regulations are adhered to.
With over 20 years’ experience in moving clinical supplies across borders in all directions and across all continents, the in-house logistics team at Inceptua is able to help clinical trial teams forecast and plan for the needs of sites in any region, and can work closely with sponsors to ensure they understand the impact of customs requirements on both costs and timescales. Once the material is available at the local depot, Inceptua can coordinate with site teams to ensure the timely delivery of clinical supplies; an important step in ensuring patients in any given region can be assured of a high standard of treatment without interruption.
Global clinical trials are challenging for sponsors but with the opportunities for improved drug development they offer, they cannot be overlooked. Hosting trials in a range of markets will be an increasingly important part of the drug development process and sponsors will need to tackle the challenges head on to ensure they are able to reap the benefits on offer.
“Wherever we operate in the world, our focus is always on the patient. Helping sponsors deliver clinical trials which maximise the possible benefit to patients is central to all our work.” says Madussi. Partnering with Inceptua provides sponsors with the support they need to navigate a difficult landscape and ensure they are able to deliver trials on time and in budget, ultimately helping develop treatments for patients in need.
Edo is the commercial director at Inceptua. Having held various positions developing Clinical Supply Chain solutions for top pharma companies, he now provides strategic consulting services to support trial sponsors. Fluent in four languages, he holds an MBA from Virginia Tech, and a Master’s in Health Management from Lugano University, Switzerland.