Coordinating the needs and roles of various stakeholders is one common challenge that every clinical trial face. Read as we explore the needs of stakeholders in Decentralized Trials.
DCTs (decentralized clinical trials) are defined as studies executed via local/mobile healthcare and telemedicine providers, using technologies and processes that differ from the traditional clinical trial model. DCTs introduce an array of technologies to tackle the challenges of running a clinical trial without a centralized, single site. While some of these challenges are unique to DCTs, others exist in both centralized and decentralized trials.
The role of sponsors and investigators
In a DCT, every stakeholder group has certain responsibilities. For instance, sponsors should produce a reliable, valid scientific evidence. The role of investigators is also important for the safety and execution of study. Regulators rely on the efforts of investigators and sponsors, as the data produced in a clinical trial offers a foundation for regulatory decision-making.
Quite a few clinical trial participants have to shoulder some burdens related to their roles. When decentralized trial tools lead to more intricacy, investigators may have to do some extra work, which hampers their ability to give the trial their full attention. Participants may be asked to collect more data or engage with new technologies without actually receiving greater control or access. While service partners and technology do their best to support DCTs, unavailability of information about existing challenges may impede their efforts.
Some stakeholder burdens are shared
In a research, several clinical trial stakeholders were surveyed, including staff members at food companies, pharmaceutical companies, and research organizations. The authors found that most survey respondents came up with similar barriers to the adoption of DCTs. These included:
- Lack of understanding or knowledge
- Regulatory challenges
- Technical issues, including data storage, validation, and standardization
- Compliance and adherence
The researchers also came across a handful of common features that may break down these obstacles and facilitate superior trials, like:
- Maintaining clear communication with patients and offering assistance
- Using the results of pilot studies to facilitate decision-making
- Making regulators part of the trial development process
Identifying potential goals, roles, and potential burdens is the first step toward improved stakeholder inclusion in the decentralized trial process. Including stakeholders early in the process may also lead to better outcomes.
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