The rising popularity of virtual clinical trials since the COVID-19 pandemic brings with it new challenges and opportunities that clinical trial staff and participants are learning about and facing together.
In this blog post, we’ll explain what exactly is a virtual clinical trial design and take a look at its benefits and potential challenges. Enjoy your reading!
What is a virtual clinical trial?
A virtual clinical trial (also known as a decentralized, siteless, or remote clinical trial) is a digitally empowered trial design process.
This new model of conducting clinical trials takes advantage of technology (like monitoring devices and apps) and the inclusion of web platforms (such as informed consent, recruitment, and counseling) to allow the participants to be home-based at each stage of the clinical trial.
Crucial equipment is delivered to the patient and support by study pharmacists and physicians is provided through video conferencing. Telehealth technologies or digital health technologies and mobile health apps are used to collect data from patients and transfer it to the research sites.
The need for participant diversity and increased data collection in trials is undoubtedly increasing clinical trial market growth.
What are the potential benefits and opportunities of conducting a clinical trial “virtually”?
In the digital age, there is increasing interest in clinical trials that don’t need trial sites. The choice to conduct a trial “virtually” can bring with it several advantages and they include:
1. Improved participant or patient engagement
Decentralized trials are great because of the reduced cost and time of traveling to clinical sites.
A virtual trial is more convenient, and comfortable. It also has greater access to treatment for those patients in remote locations or with mobility problems.
2. Better data collection
A research organization doesn’t have to depend on the trial team to transmit the collected data or patient-reported outcomes, which can be accidentally edited or lost.
The data is transmitted from wearables (such as a Fitbit and Apple watch) or smartphones to the clinical database. This makes the collected data to be of a higher quality and richer.
3. Reduced burden on the participants
Planning a visit to the trial location can be stressful and costly. Getting rid of the need to visit the trial locations ensures that participants don’t have to go through the hassle and burden of traveling to the sites.
The patient doesn’t also have to keep track of the symptoms they might experience since these clinical operations are completed day and night, and adverse events are usually analyzed and even treated quickly.
4. Quick patient recruitment
Patient recruitment and screening via social media platforms allow sponsors or staff to fill trials faster than in traditional trials. A remote trial makes it easier for volunteers to participate and improves participant retention.
5. Better communication
Using technologies allow patients to easily connect with trial staff. This real-time communication and collaboration boost health outcomes and healthcare of the trial, making participants feel secure.
6. Data security
The risk of sharing personal medical information over the internet can cause participant privacy concerns. Some participants may not be willing or comfortable using devices like wearables all day.
The challenges of site-less or virtual clinical trials
Virtual trials are in the early stage of their adoption, meaning pharmaceutical companies or research sites still have many challenges that have to be resolved. They include:
• Cultural, communication, and language barriers
Cultural and language barriers can bring virtual communication issues between trial physicians and participants. It’s also difficult to know online if a patient is feeling unwell, confused, or even hesitant about specific aspects of the trial.
• Operational challenges
Trials that need medical procedures and tests can’t be conducted virtually since they need to be carried out in a medical setting by a medical profession.
Virtual Clinical Trials
This strategic study design requires patients to communicate via electric devices. They are opportunities and challenges with virtual trials and it is up to your organization to determine if this trial design would be beneficial for your clinical research goal.
Having hybrid trials is great since it combines the benefit of having a trial “virtually” and in-clinic or traditional ones. Patients have the chance to communicate face-to-face with trial staff and undertake medical procedures or tests in the comfort of their homes.
David Pisse, a seasoned software developer and AI enthusiast, brings over a decade of experience in innovative technology solutions. With a passion for blending AI with traditional development practices, David offers unique insights into the future of software engineering.
