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NEXT GENERATION CLINICAL TRIALS RELY ON A WIDE-REACHING, RESILIENT AND RELIANT LOGISTICS NETWORK

Is the pandemic-proof supply chain model ready for mass adoption?  Here DHL's Thomas Ellmann Head of Clinical Trial Logistics shares his views on how the success of decentralized trials rests on the strength of the supply chain.

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What a Difference a Year Makes

Before COVID-19 shook our world, I think it’s fair to say the public gave little thought to the vital role clinical trials play in advancing medical science. Unless you work in the industry, or were taking part in a trial, there wasn’t much need to think about it. 

I do of course work in the sector. I’ve also taken part in a trial. That gives me a pretty unique perspective on the whole landscape – one that is both professional and personal. And it’s from that viewpoint I can tell you that a year on the picture looks very different. 

Large numbers of the population are now not only aware of the importance of clinical trials, but also actively following their progress, and signing up to participate in greater numbers than ever before.

This unprecedented hike would never have happened pre-pandemic, but not all studies have benefited. In fact, I’ve seen other figures that show a staggering 80% of non-COVID-19-related trials have been curtailed or interrupted precisely because of the virus. And though things are beginning to get back on track, it’s clear there’s a new sheriff in town: traditional site-based studies are on the out, and decentralized trials are here to stay. That’s not to say coronavirus is solely responsible for the shift. 

We’ve only to look back a couple of years to see that the sector was already on the brink of change, largely due to the high costs involved, the lack of diversity in patient groups, and falling engagement rates. 

Rather, the COVID-19 crisis has accelerated the demise of traditional trials and the rise of hybrid or virtual studies, just as rapid advances in medical understanding and technological know-how have made it possible to transport trial treatments safely to a patient.

Benefits of a Patient-Centric Approach

Decentralized clinical trials offer several benefits that reduce the burden often associated with conventional models. The fact that much of the treatment takes place in a person’s home means trial sponsors can better access and attract a wider, more diverse patient group. 

And because patients don’t have to travel to study centers – often a considerable distance away – we tend to see an increase in adherence. Although this approach necessitates some new systems and technologies to be in place, there is one constant factor that remains: the supply chain can still make or break a trial. 

If deliveries fail, patient outcomes, clinical endpoints and licensing approvals are on the line.

80%

Of non-covid-19 related trials have been curtailed or interrupted precisely because of the virus

100% compliance

Is needed in terms of medical regulation and data security when delivering trial treatments to a patient

The Devil's in the Data

Delivering trial treatments directly to a patient isn’t straightforward – it’s not as easy as getting any courier service to pop a parcel on the back of a bike: the logistics solution needs to be 100% compliant, both in terms of medical regulations and data security. 

Patient confidentiality wasn’t something we were heavily involved in when delivering products to trial centers. Transporting treatments direct into someone’s home is another story entirely. 

Regulations around data security have, rightly, increased in recent years and so it’s essential logistics companies have processes in place to safeguard patient information at all stages of the supply chain.

In Experience We Trust

If trial sponsors want to maximize on the potential of a diverse study group, their logistics provider needs to have a wide-reaching network that’s as resilient as it’s reliable. I know that when I’m speaking to a sponsor, I need to be able to offer the same level of service in a developing country as I would in, for example, Europe or the U.S.

Shipping into a territory is one thing, but having an established local network in place when you get there is non-negotiable if you’re hoping to deliver product intact and on time to the end user, regardless of terrain, climate or infrastructure.

We recently used our multi-territory experience to help a clinical research organization (CRO) rationalize its trial offering across 80 countries. The CRO was incurring excessive warehouse and transport costs because it was storing, shipping and returning unnecessary stock. We used our new, global order fulfilment center to increase visibility and implement an improved reverse logistics loop for clinical returns. 

 

Clearly, a logistics operation of our scale isn’t something you can build overnight. We’ve spent two decades investing and establishing 23 depots, supported by a global network that’s as compliant and dependable in the air as it is on land. And by dependable, I mean regardless of the unforeseen. 

When the enormity of COVID-19 hit, commercial flights were grounded, shipping capacity dropped practically overnight, radically limiting outbound distribution and inbound returns. Fortunately, our air fleet was able to operate, meaning our customers were insulated from the worst of the impact.

 

80 Countries

Received a trial offering from a clinical research organization with the help of our multi-territory experience

300%

Increase of direct-to-patient shipping in the next four years

Seeing is Believing

Despite its importance, a network isn’t everything. Yes, it’s essential for a global supply chain to function properly, but if 20 years in the industry has taught me anything, it’s that customers want transparency. 

They need to know when their product has shipped, where it is at any given moment, and that its quality has been maintained every step of the way. Equally, patients have some non-negotiables of their own. 

Naturally, they should be able to rely on their treatment arriving as and when expected, but they also need to trust that we’ve been as careful with their data as we have been with their delivery. These things are only possible with the aid of a fully IT-enabled supply chain management system – one that can offer continuous monitoring, real-time visibility, and unimpeachable data security.

Success Hinges on Strength of the Supply Chain

As I mentioned, years ago I participated in a clinical trial. I was, of course, keen to help advance medical understanding, but I also wanted the chance to experience the process from a patient’s perspective. 

These days, I’m professionally involved in delivering trial treatments to thousands of people - and I can only imagine that number is going to grow. I saw one stat estimating that direct-to-patient shipping will increase by 300% in the next four years, and I’d hazard a large proportion of that will be because of decentralized trials. 

As we’ve seen, they have the potential to reach more patients from wider geographies, resulting in greater diversity; they can reduce the patient burden; and they can deliver increased adherence. 

But, as I hope I’ve made clear, these things will only happen if the supply chain can also deliver - at every stage, on every day, and in every continent, regardless of whatever unknowns lie ahead.


Thomas Ellmann

Vice President, CSI Life Sciences & Healthcare, Head of Clinical Trials Logistics

Thomas has been an instrumental figure in the DHL Life Sciences & Healthcare sector for over 14 years.

As a Global Sector Team member, Thomas is now leading the cross-divisional development of clinical trials logistics offering. He recently co-authored the white paper “Pandemic Resilience” and is central to business development efforts in DHL’s Global Task Force to support distribution readiness for global vaccine manufacturers, governments, and NGOs. Thomas is also leading the company’s COVID-19 vaccine distribution strategy.

Previously, Thomas was Sales Leader for EMEA, including Emerging Markets in the Middle East and Africa, where he had responsibility for an extensive portfolio of pharmaceutical and medical devices companies. Before joining the DPDHL Group, Thomas spent several years in FMCG and specialty chemicals industries, where he held roles in supply chain and customer services. Thomas holds a Master’s degree in Physics from the WWU Münster, Germany. 

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