Why you need to engage DCT study vendors earlier to assist in designing decentralized clinical trials
There are several ways to incorporate decentralized components into clinical trials that can leverage specific solutions to create decentralized clinical trials (DCTs) or fully virtual clinical trials (sometimes called siteless trials) from the original protocol. This can be done through the incorporation of wearables and other technology, ePRO software, eConsent software, remote sample collections or drug distribution, telehealth capabilities, and much more. The key, however, to successfully running a decentralized clinical trial is being able to incorporate these components seamlessly and with as little additional cost and burden as possible.
Some of the most common considerations when designing any clinical trial are things like regulatory requirements, protocol development, recruitment goals, and site activations, just to name a few. Yet, when it comes to decentralized trials there are many additional considerations needed which can include virtual/traditional site activation and management, data privacy and security on your decentralized platform, remote patient monitoring, decentralized recruitment tactics, patient technology access and knowledge capacity, and more.
The Association of Clinical Research Organization highlights, in-depth, the many considerations that go into properly designing a centralized or decentralized clinical trial. However, the ACRO manual states “Early engagement [with stakeholders] should be considered at the soonest possible point and planned from the outset. The practical and operational aspects should be discussed from all perspectives and subsequently built into protocol design discussions and cross functional risk management decisions.”
Why is earlier better?
By including a chosen DCT study vendor in the study design, trial protocols can be fortified in a way that allows for necessary adjustment. This can refer to situations where optionality is offered for patients and/or providers participating in the study. If the protocol allows patients to be seen either through telemedicine appointments or in-person appointments, it can reduce unnecessary in-office visits while also ensuring that providers and patients can choose the best appointment option for them.
Without a flexible protocol being developed and approved in a DCT study, there is very little wiggle room or optionality within the study. The lack of rigidity is one of the major benefits of decentralized clinical trials. This type of model is adaptable yet durable when properly developed. Excluding DCT study vendors during the design period can result in a trial lacking proper, optimized DCT study capabilities and solutions.
Oscillating Site Recruitment/Activation
A notable capability of decentralized clinical trials is their ability to include various traditional and virtual sites in a single trial. For example, a decentralized trial studying a diagnostic device for an infectious disease may benefit from virtual sites that can participate in the trial remotely. Not only does this limit the need to travel for patients infected, but it also allows the study to include specific sites that are located in endemic regions where patients would otherwise be unable to travel to research centers.
Furthermore, as infection rates fluctuate in specific areas, some full-service DCT vendors have the ability to oscillate to those regions and activate new sites where the infection rates are highest. This enables the study to reach a larger target of potential participants. These capabilities, however, are often hard to work into a trial design after the fact. By working together with DCT vendors, the need for the type and location of specific sites can be deduced much earlier in the design process to ensure that what is needed is accounted for and incorporated.
Minimizing Cost & Burden
Despite the fact that some DCT vendors can work backward and incorporate crucial DCT components after a trial has already begun, this can be a timely and costly initiative. As an example, in a study, patient blood collection was originally designed to take place in-person at collection centers, however, patients are appearing to be very unlikely to contact a collection center and travel to those centers to give a sample. This process to them is timely and difficult to fit into their schedule. However, the current DCT vendor offers remote sample collection using mobile phlebotomists where patients are prompted directly on the patient platform to schedule a time for the phlebotomist to visit them and their desired location (home, work, etc.) to take the blood sample. The decentralized sample collection model mitigates the time and travel requirements on the patient end making it easier to move patients through the study.
Implementing this type of decentralized component into a trial can be seamless and done with very little complexity. But, trying to implement this component later on in the trial in an attempt to boost patient retention can be costly and require a lot of time and resources. Furthermore, not having implemented the right type of collection component from the study’s inception has cost the study time, participant numbers, and costs.
Optimizing Patient Experience
Patient experience is a key component in any trial for maintaining optimal levels of engagement and retention throughout the study. Although some elements of a DCT study (i.e. device optionality, telemedicine, at-home testing, ePRO software, eConsent software, etc.) will typically boost patient experience, consistency and patient education can also play a role. Patients should feel well educated and properly informed throughout their participation in a study. Adjusting protocols, reorganizing patient workflows, or reassigning patients with sites can create a choppy less cohesive experience. Including all necessary DCT study elements in a trial that is holistically and collaboratively designed can help ensure fewer roadblocks for patients.
The idea of doing something right the first time is not lost on anyone. In order to build the most efficient and successful trial, it is important to include all stakeholders in the design process. DCT vendors can and should be partners in the creation of decentralized trials. Their expertise in decentralized trial execution is crucial in discerning what a DCT study needs from beginning to end.
Learn more about what goes into designing a decentralized clinical trial in Curebase's Clinical Sites Guide.