Contributed Commentary by Caroline Jackson, mdgroup   

March 3, 2023 | Remote data collection may make clinical trials more convenient for patients and more efficient for sponsors, but it also comes with a layer of complications. Chief among them is managing the logistics of distribution and the supply chain, as there is no room for error.  

Protocols are planned down to the last blood draw or outcome measurement, so sponsors need to be sure that the right people with the right equipment are in the right place at the right time. Anything less threatens data quality, patient safety, and regulatory compliance.  

Yet when hybrid and decentralized clinical trials (DCT) rely on a patchwork of different suppliers, vendors, and couriers, logistics become a huge administrative burden for sponsors and sites alike. And with so many moving parts, the chances of vital tasks falling through the cracks between providers are high.  

That’s why an integrated project management approach to home health and distribution is vital.  

New Model, New Considerations   

The benefits of hybrid and DCTs have been well documented. This model replaces at least a proportion of site visits with remote data collection and was accelerated during the acute phase of the COVID-19 pandemic. The result was a goldmine of evidence that showed these trials were more convenient for patients and efficient for sponsors. They can help improve recruitment, retention, and accelerate the drug development pathway.  

Less discussed in the literature, though, is the model’s common pitfalls. If the industry is to wring every drop of potential out of this new way of doing things, it needs to be aware of the likely stumbling blocks and know how to step around them gracefully.  

One possible hazard with a straightforward solution is the logistical jigsaw puzzle that hybrid and DCTs present sponsors.  

The Distribution Jigsaw  

Logistics may be a relatively low-tech component of a clinical trial, but, as anyone who works in the industry knows, it is extremely important and will only increase in consequence as the sector moves to hybrid and DCTs.  

For example, a lack of phlebotomy equipment on the protocol-specified day of a blood draw has always been a concern. While a site usually has a backup solution on hand, the same logic does not apply to a home health visit. In that case, the remote visit may need to be repeated at a potential cost to the client and inconvenience to the participant. Furthermore, the data could be lost from the trial, and any resulting safety signals would be missed.  

The nature of the DCT setup can make eradicating such challenges extremely difficult. Often, separate companies will be responsible for fulfilling siloed functions, such as home health, central laboratory processing, equipment supply, or delivery. Despite all working on the same supply chain, they do not always communicate effectively with each other. Instead, they create a catalog of moving parts for sponsors to monitor and manage.  

In addition, some members of this chain, such as couriers, may have limited experience in the research arena. It means they often need to be made aware of the relevant regulations and just how important timely collection and delivery is to the continuation of a study.  

Currently, sponsors take on the considerable administrative burden of joining the dots between the providers. It can include a series of emails or telephone calls to different contacts before and after each scheduled visit. Multiply that across the organization’s portfolio, adding to a colossal use of time and resources. And, sooner or later, something will fall through the cracks.  

Owning the Process   

When there are so many moving parts, the solution must be to consolidate as many as possible, which is where the holistic project management approach to logistics comes in. Seamless, integrated solutions can join the dots between disparate stakeholders by bringing study-critical elements in-house and then taking on the critical responsibility of the clinical supply chain.  

Industry-leading partners can provide the right people through home health services. With their own distribution centers and couriers, and strong relationships with sites, suppliers, and central laboratories, they can also make sure these highly skilled professionals are fully equipped for whatever is needed for every engagement with patients.  

For example, when the protocol calls for a patient welcome pack to be printed and delivered before the patient’s first day and a blood pressure reading to be taken on day five, a joined-up service could deliver on all fronts from a single brief. Likewise, when there’s a last-minute change of plan, open communication channels within the departments means they can adapt quickly, and sponsors need only speak to one contact.  

Such providers can manage safety and compliance concerns, such as calibrating medical tools according to manufacturers’ guidelines and cleaning, disposing, and quarantining equipment where appropriate, all while ensuring the doctors and nurses in the field still have what they need.  

Additionally, these providers would have their own couriers who are well-versed in the rules and regulations of clinical trials and can even provide laboratory kit assembly, storage, and management—all tasks which can eat up time and space at clinical trial sites.  

Holistic Logistics   

Logistics may be one of the biggest challenges facing the sponsors and sites designing and conducting hybrid and DCTs. Healthcare teams must have everything they need to complete their work no matter where, when, or what is required. Getting such logistics right the first time is critical, but this is becoming increasingly more complex and time-consuming. However, failure is not an option.  

The joined-up project management approach enables a trusted partner to join the dots between patients, home health, sites, equipment suppliers, central laboratories, and couriers. It connects the entire logistical network, removing the safety, data quality, and compliance risks between providers. It also eradicates the huge administrative burden from sponsors and sites and ultimately clears the path to DCT success.  

Caroline Jackson is the executive vice president of patient services at mdgroup. With over 27 years in the industry, Jackson brings a wealth of knowledge and understanding of the clinical development process to her role. She is passionate about the future of clinical research, the use of new technologies, and other decentralized solutions to facilitate better patient care.  She can be reached at caroline.jackson@mdgroup.com.