Participating in clinical research from your home

Until recently, the only way to participate in a clinical research trial required multiple visits to an office location. This has limited enrollment by individuals that are good criteria matches but just live too far away. Now, with faster and better internet connectivity, wide usage of mobile devices and wearable technologies, there are new ways of conducting clinical studies. Today such “decentralized” trials, or DCTs, have activities that happen virtually, commonly at the participant’s home. This highly patient-centric experience offers both ease and flexibility.

Here are common components of DCTs. You are probably familiar with many of them.

Virtual appointments with the study team through online televisits

Here participants use an app to attend required study visits. These days televisits are quite commonplace and many adults are experienced with the technology. Also a person’s home is simply more comfortable than an office. During flu season, it may help with limiting potential exposure. Finally, this capability saves valuable time that would otherwise be spent in transit or a waiting room.

Home delivery of study medications and supplies

With direct delivery, study medications, detailed instructions, and needed devices are shipped directly to the participants’ home. If the study medication is temperature sensitive, it will come packed with thermal material to protect the medicine until it can be put into a refrigerator. From here the participant either self-injects or waits for a home visit depending on the protocol.

Wearable devices to safely record health data

Trials are increasingly adding smart devices to help with patient data collection. For example, a heart disease trial might provide a smartwatch to record heart rate changes throughout the day. This data is then shared with the study team directly from the smartwatch. Ten years ago this would have required a home visit with a study nursing professional.

Mobile nurses and clinical professionals who perform sample collection and study visits at the participant home

Today home visits can be used to perform participant blood draws when lab work is required. Some people like this approach because they have anxiety around needles. Others still prefer to go a nearby lab, which can also be offered in a DCT model. The idea is to provide convenience and choice where possible. With fewer site visits overall, participants can stay engaged and retained in research without too much disruption to daily routines.

Though a DCT is performed in a different manner than a typical site-based trial, both approaches are governed by strict safety, privacy and data usage regulations. Studies that tend to work best for the DCT design are more likely to incorporate technologies and other remote elements. Some examples include:

• Chronic condition studies (e.g., diabetes, hypertension): participants can use connected devices to share readings.
• Rare disease trials: with small numbers of patient populations, DCTs offer participant engagement regardless of where an individual happens to live.
• Observational and post-marketing studies: these often require real-world data collection that can be captured in a non-invasive approach.
• Behavioral health and lifestyle interventions: these protocols easily leverage telehealth approaches and related digital tools.

Despite the advantages of DCT, most trials have remained ‘traditional’ meaning they are executed at central/physical office locations. There is also a hybrid model that is a combination of both elements. Design decision-making is based on several factors. First, some studies require imaging or procedures, such as a biopsy, that can only be done at a special site with devices and expertise.  Second, there can be technological barriers. Some individuals live in areas with poor internet speed while other people may feel distrustful of technology. Third, using a DCT approach means a PI must be comfortable giving up control of some operational aspects of trial delivery.

Still, the outlook for DCTs is bright with anticipated growth in the next few years. Newer FDA guidance making it easier for remote trial execution is one reason more DCT adoption is expected. Advances in wearables and AI will only accelerate remote data collection and analysis. Practically this all helps reach individuals that otherwise would never be able to participate in research. In this sense, DCTs make it possible for more people to contribute to medical progress without putting life on hold.