The evolution of clinical trials: from investigator sites to direct-to-patient protocols


2020 was a year of dramatic changes, from Brexit to the COVID-19 pandemic, and the world of clinical trials has been no exception. With site closures and study participants unable to travel, the modus operandi of clinical trials has had to quickly adapt to new ways of running. At Woodley, quick thinking and operational resourcefulness have been essential to meet this challenge.


Clinical trials are typically run in specialized centers, however some trials are adapting into a more patient friendly direct-to-patient (DTP) approach, allowing patients to enroll and participate in trials from the comfort of their own homes. This practice benefits patients and reduces the trial costs, as they are coordinated entirely virtually. It is also more efficient from a data collection point of view, as data can be quickly transferred by the patient to clinical databases using a smartphone. Despite these benefits, this model has its own challenges, particularly from a standpoint of supplying equipment and specialized medical materials to patients’ homes, rather than a fit-for-purpose building. At Woodley, we have had to adapt to this new way of working in order to continue to provide a reliable and high quality service worldwide. 


Supplying medical equipment to clinical trials involves a carefully coordinated operational task force, particularly when supplying worldwide, as each country will have their own regulations and safety guidelines. For DTP studies, kits will get to patients via a central pharmacy or visiting nurses, and so having reliable shipping systems in place is essential, as equipment needs to be tracked and accounted for at all times. Customs plays a large part in this, and having a team of people at Woodley with expertise in shipping medical equipment has really helped us to keep providing to customers with quick turnaround times. This has given us the flexibility to, for example, deliver straight to patients within 24 to 48 hours of notice, and has been critical for us to adapt to our customers continuously changing needs.

Another challenge that arises in DTP trials is having specialized staff trained to use the medical equipment from the patients’ homes. In our case, this was not a complex issue to overcome, as we already had a training service in place. This meant that hospital staff could easily adapt to working from a patient’s home setting after they had received adequate training on how to use our equipment. Consistency from users is important for obtaining reliable trial results and we were able to maintain that service for our customers as they transitioned to DTP.

The know how we gained from previous DTP trials proved to be a massive advantage during the first peak of the COVID-19 pandemic, when a lot of trials suddenly changed into this format. It meant that we already had protocols and operations in place, allowing us to continue to provide equipment to our customers in a timely manner, even when they changed their operations at short notice. The fact that we already had efficient procedures set up to calibrate, decontaminate and clean the equipment before shipping also meant that our services were able to carry on safely. This allowed us to maintain the trust of our customers while keeping our staff safe, which is critical for both our business and the patients.


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