Since the outbreak of the pandemic, there have been many changes to clinical trials. Many trials that were once conducted in health and research centers, for example, have been moved to patients’ homes or places near where they live to minimize exposure to the coronavirus and observe social distancing requirements.
This article discusses what you can expect if you’re participating in a clinical trial that is being conducted at or near your home. These types of clinical trials are referred to by many different names including remote, virtual, site-less or decentralized clinical trials. These terms all describe clinical trials where participants interact with the principal investigator and the rest of the study staff virtually, through the use of the telephone, the internet and mobile devices. In some instances, these types of clinical trials involve trained nurses or clinicians who visit participants in their home—or another convenient location—to conduct the study procedures and examinations. Even in virtual and remote clinical trials, study participants may be asked to travel to the research center for certain visits such as screenings, baseline assessments and comprehensive examinations.
For many remote and virtual clinical trials, participants are loaned a smartphone or handheld device preloaded with a study application and data plan that allows for secure video-based telemedicine visits and the ability to directly communicate with the study coordinator at anytime. These devices may be used to send text and email reminders to complete questionnaires, perform a simple procedure and take study medicines. Participants may also receive devices to measure their own vital signs —such as blood pressure, temperature and pulse rates — during telemedicine visits with the research staff. In some clinical trials, participants may be asked to wear sensors, such as a Fitbit or Apple Smart Watch, to continuously measure health data including heart rate or activity levels.
Nurses and clinicians who visit patients’ homes receive training on the clinical trial protocol and must follow strict quality-control requirements. They typically bring all of the necessary equipment, such as blood pressure or portable heart monitor machines, to home-based visits and the procedures occur just as they would at the study site. Samples are usually processed in the patient’s home and then sent to labs for analysis. Any unexpected symptoms or side effects are reported to the principal investigator immediately and appropriate action is taken. Mobile nurses and clinicians submit reports following each visit and discuss any important details with the principal investigator and study staff.
For some virtual clinical trials, investigational drugs may be shipped directly to and administered in the patient’s home. Depending on the particular study, patients and their caregivers will either receive instructions on how to take the medicines themselves or the visiting nurse or clinician will administer the study treatment during the home visits. Direct-to-patient deliveries are arranged in advance and either the patient, or an authorized caregiver, will need to sign for the study medication when it arrives. If the patient is not home for the delivery, another time will be scheduled; packages won’t be left on the doorstep.
In virtual clinical trials, study volunteers need to record when they take their study medication. Studies may use an automated adherence tracking device including a sensor in the medication package or software application. Some investigational therapies need to be stored at certain temperatures. In these instances, study volunteers may receive a mini-refrigerator with features that allow researchers to remotely monitor not only the storage temperature, but when the drug was taken.
Remote and virtual clinical trials offer convenience to study volunteers and reduced risk of exposure to COVID-19. Most people like the flexibility and ease of participating in a clinical trial at home or nearby. But remote and virtual trials place even more responsibility on participants and their caregivers to follow the protocol, receive and send materials, stay connected, take study medications, use technologies, and perform procedures on their own.
Here are some important questions to ask the principal investigator and study staff to help you decide whether to participate in a virtual or remote clinical trial:
- How will study visits occur?
- How many visits will be conducted at or near my home and how many at the research center?
- Can visits be done in the evenings or on the weekends?
- Will there be telemedicine appointments?
- What will be done during each visit?
- How long will each visit last?
- Where will blood draws and other procedures be conducted?
- What other medical tests will be required?
- Will a research nurse or study representative come to my home?
- Will I always have the same nurse visit my home?
- What training and experience does the visiting nurse or clinician have?
- Can I meet the nurse or clinical and discuss any concerns before the in-home visits begin?
- How will my safety and privacy be protected?
- How will I receive the drug or device being tested in the clinical trial?
- What if the drug or device doesn’t arrive?
- How will technology issues be supported (e.g., a device stops workin or a Wi-Fi and cellular connection can’t be established)?
- Who should I call about any questions or problems during the clinical trial?
This article is an excerpt drawn from The Gift of Participation, an in-depth guide to making informed decisions about volunteering for a clinical trial. For more information go to: www.ciscrp.org