Remote clinical trials, also referred to as decentralized or virtual trials, have emerged in popularity over the last few years owing to many factors including the COVID-19 pandemic. These trials utilize innovative technologies to perform many study procedures in a remote fashion, which improves patient access and involvement in the trial. Nonetheless, remote clinical trials have their share of challenges in remote clinical trials which would compromise the benefits that are intended to be derived from them. The challenges associated with remote clinical trials are explored, including the difficulties which researchers must contend with, as well as possible solutions for these problems.
Key Challenges in Remote Clinical Trials
Patient Participation and retention in Remote Patients.
The most critical barrier posed in running remote clinical trials is the patient engagement and the retention rate of participants. In traditional clinical trials, the participants are seen traveling to medical facilities, but in remote clinical trials, home-based engagement leads to much less motivation and commitment. Such lack of face-to-face interaction can lead to feelings of detachment from each other which makes it all the essential for the researchers to develop approaches which encourage immersion and interaction. Mobile apps and wearable devices in remote clinical study assist in virtual check ins increasing individualized contact and boosting engagement of study participants during the trial.
Lack of Access to Information Technologies.
The access to technologies such as video and teleconferencing platforms varies between populations leading to inequities in their usage among patients. There may be some patients that do not have the required gadgets along with the digital skills necessary for engagement in remote clinical studies, hence, such populations, more so the aged and low socioeconomic class may find it difficult to participate. For this barrier, working with common clinics or community centers can provide gadgets and other relevant technologies for the recruits ensuring that all people can participate.
Acceptable Data Security and Privacy Mechanisms.
Deriving most of the data collection on virtual platforms raises a lot of issues centered around data security and patient information protection. Speaking of health information, HIPAA compliance is essential with the sensitive information being shared over the internet. Additionally, the researchers need to take appropriate steps to secure the patient data and put in place procedures to comply with the relevant legislation.
Compliance with Regulations
Surmounting the array of regulatory obligations remains another concern that is associated with remote clinical trials. The international norms that govern the performance of these clinical trials are different for each country complicating the various levels and stages of obtaining approval and adhering to compliance throughout the research trial. Developing outreach strategies for regulatory agencies and employing proactive communication with them is one of the strategies which can be adopted to address this problem. Further, the employment of multiple data sources within a single framework is important in reducing chances of errors and improving operational efficiency.
Behavioral Resistance
There are sponsors and sites who have been hesitant in adopting this model of clinical trials as this involves replacing in-person interactions with virtual ones, which raises questions on how effective virtual interactions are compared to traditional ones. This behavior, referred to as inertia, has the detrimental effect of slowing down the acceptance of new ways of working in clinical research organizations. In order to overcome this issue, stakeholders have to be informed about the advantages in remote clinical trials as well as offered proof that supports their efficiency.
Strategies to Deal with Challenges in remote clinical trials
In the advent that challenges facilitate inadequate outcomes in remote clinical trials, the following can be adopted to ensure the effective and optimal performance of remote clinical trials:
- Improve Patient Involvement: Use technology to build participatory technologies across participants and researchers.
- Train Participants: Implement training sessions that prepare participants well on how to work with domesticated tools.
- Augment Data Safety: Introduce sophisticated encryption to safeguard patients’ details and follow rules of professional ethics.
- Encourage Regulation: Work with agencies from the inception of the study to know their expectations and simplify compliance.
- Use Software: Put resources in systems that allow collecting data from various sources in a coordinated fashion without compromising data quality.
Conclusion
In spite of many challenges in remote clinical trials, which risk – allowing to further the goals of medical research due to reach better and greater diversity of research participants. Tackling these obstacles with appropriate planning and using modern technology can allow researchers to take full advantage of the advantages of decentralized clinical trials without compromising security and integrity of patient and research data. Adoption of these changes is going to be fundamental as the clinical research sector is being transformed in concordance with new demands and invention of new technologies.