Remote Patient Journey During A Clinical Trial
The ongoing COVID-19 pandemic has highlighted the importance of clinical trials. But, it has also shown their fragility and susceptibility to disruption. With ongoing and planned studies facing many interruptions, remote trials have become an urgent necessity.
Currently, they are the only real option for new investigations. Now, they need to involve the incorporation of ‘’siteless’’ elements. This means decentralizing many aspects that are traditionally performed face-to-face. Thus, many areas of health have adopted digital monitoring methods.
The Remote Patient Journey
The current pandemic means that clinical trial participant numbers are down overall. However, remote recruitment makes it easier for investigators to identify, recruit, and enroll patients. Recruitment can be expanded globally through the use of social media.
Timelines become shorter than usual, with patients no longer needing to travel to enroll and consent. Instead, they simply sign e-consent forms. Such a method makes it easier to approach remote groups, such as the elderly, from the comfort of their own homes.
Each trial will perform this process differently. However, most will include some standardized stages. A patient questionnaire will likely be the first step to assess the severity and stage of the condition. If the patient meets the initial eligibility criteria, the patient engagement team will contact them. This conversation will consist of medical history questions such as:
- Current medications and treatment
- Medical condition diagnosis
- Previous experience with certain medications
- Other medical conditions
- Logistics of a clinical trial
Clinical trials are usually double-blind investigations where neither patients nor researchers know whether the administered medication is active or a placebo. This depends on the kind of treatment and condition being assessed by the trial. For example, the active study drug may come in a variety of doses.
Before taking the first dose, additional patient tests, such as blood samples or questionnaires, might be necessary. This is usually to ensure safety and for the sake of comparison before and after the trial.
Once a patient has been matched to a study, they will be sent a full information sheet. This will explain the study protocol, such as the number of visits or specific assessments involved.
Next, patients will likely be placed in contact with the clinical staff. Here they will have the opportunity to ask any remaining questions. This is usually followed by a screening visit, in which the doctor outlines the trial in detail, checks suitability, and ensures safety. The suitability check involves an extensive medical checkup, with specific tests depending on the focus of the trial.
Collect ePRO/Diary/Wearables Remotely
Virtual health monitoring technology is the foundation of remote clinical trials. This can include anything from smartphone apps to wearables (think FitBit), to bespoke e-diaries. They allow patients to send data on their physical state and wellbeing with ease and speed. Information on anything from heart rate to blood pressure can be collected, sent, and analyzed automatically.
With the rise of online information transmission, data protection laws and requirements have tightened everywhere. There are valid concerns over sharing patient personal and biometric data over the internet. Even the largest organizations can experience hacking. Fortunately, end-to-end encryption increasingly protects novel technology.
So, the priority of most trials is to reassure patients that the investigation is safe, ethical, and patient-centered. There is usually a follow-up period of phone calls post-treatment to ensure the medication is still safe and effective.
Partnering With Technology Partners For Seamless Remote Patient Journeys
Researchers can work with technology partners to improve patient experience in remote trials. For example, technology allows for seamless delivery of electronic consent, digital medication, and visit notifications for televisits.
Technology partners can assist with online data collection via the web or a mobile platform. They also have the resources to spread awareness of how clinical trials can benefit patients.
Such digital tools help both the patient and researchers, who can gain better insights into patient lives outside hospitals. Day-to-day events can exacerbate a condition and remote trials highlight these changes. Investigators can channel this information into the development of improved therapies and digital strategies.
Recent events have highlighted the importance of remote trials in the future of healthcare research. But, both patients and providers must be on board for the idea to really take off. It provides a new way to manage critical conditions, particularly in the face of the current pandemic. Such a process can be made smoother by working with technology partners, who make patients the focus of their work.