Clinical studies: The basis of modern medicine

Clinical trials are crucial for drug development and the future success of pharmaceutical companies. However, they are a complex, time-consuming and enormously expensive process. A new, integrated approach to logistics means that companies have one less thing to worry about.

Rigorous clinical trials are the foundation of modern medicine. Before a new drug is authorised by the regulatory authorities, its manufacturers must prove the efficacy and safety of the product through carefully controlled tests on representative patient groups.

Before being sold, a new medicine undergoes three or four trial phases. The number of trial subjects is gradually increased, from less than 100 in early tests to investigate the safety and efficacy of the product to several thousand in "phase 3 and 4" trials, which are designed to confirm the safety and efficacy of the product in a diverse patient population.

Worldwide, the pharmaceutical industry spends around 40 billion dollars a year on clinical trials, and costs are rising by more than 5 per cent annually. This is due to the increasing complexity of modern medicines, the need to test with multiple patient groups in different parts of the world, and the difficulty of finding and recruiting participants for trials of drugs targeting rarer diseases. Companies need to get clinical trials right. A lot depends on them: the safety of trial participants, the treatment outcomes of future patients and the investment of around 2.8 billion dollars required to identify, develop and test a new drug.

Logistics is both a significant cost driver and a pain point in all clinical trials. Running a trial requires the coordinated distribution and delivery of numerous items to multiple sites. This can include everything from sensitive, high-value biopharmaceutical products that require specialised temperature-controlled transport, to computers, diagnostic equipment and clinical supplies. Today, these logistics activities are highly fragmented and involve multiple suppliers and service providers. It is difficult, time-consuming and error-prone to ensure that everything is in the right place at the right time and ready for trial participants. No wonder the world's top 20 pharmaceutical companies spend around 2.6 billion euros (3.2 billion dollars) a year on research and development logistics.

A team at the DHL Start-up Laboratory has recognised the challenges and is working on an innovative new approach that aims to simplify and streamline the entire logistics process for clinical trials, with the patient at the centre. DHL calls its new system iNebu. The name is inspired by the biblical King Nebuchadnezzar, who presided over the first recorded 'clinical trial' when he was asked to compare the effects of a 10-day diet of water and vegetables with his own richer diet of meat and wine.

"DHL understands how critical clinical trials are to the industry and recognises the need to improve the logistics of managing a trial," explains Claudia Roa, VP Life Science & Healthcare, Customer Solutions & Innovation Americas, DHL. "Our goal is to work with our customers to improve the process for them, their trial sites and other clinical trial stakeholders. By digitising our services, we can simplify the process and create better visibility for both inventory and shipping. Ultimately, it's about ensuring that delivery is timely, compliant and cost-effective.

The project required skilful behind-the-scenes integration, linking DHL Global Forwarding's existing 21 CFR 11-compliant, cloud-based LifeTrack ecosystem with the systems operated by DHL Express and DHL Supply Chain. It also has a human element, with control towers staffed by clinical trial logistics specialists who coordinate deliveries and handle issues and exceptions if they arise. However, all of this is largely invisible to the end user, who can get a complete overview of all shipments related to a particular trial or patient through a single interface or via a secure mobile app. iNebu is currently being used by two pilot customers, and a wider rollout is planned for later in the year.