• December 9, 2023

Decentralizing Clinical Trials Can Improve Healthcare 2023

We need additional clinical trials as medical research improves. Trial delays are problematic. Academic medical facilities, which are centralized, host most trials. Not all hospitals undertake studies, therefore an eligible patient may not be near a study, which is a major barrier to care.

According to CenterWatch, 85% of clinical studies fail to recruit enough participants and 80% are delayed owing to recruiting issues, resulting in daily losses of $600,000 to $8 million.

If we don’t act, this terrible bottleneck will worsen. McKinsey says that decentralization is essential to this goal. It entails bringing more trial activities to patients rather than taking patients to trial sites.

Decentralization has streamlined clinical trials and may enhance the health care ecosystem, including patient and physician experiences.

Decentralization Argument

Decentralization in clinical trials reduces patient travel to trial sites, making participation easier. Decentralization often involves health care personnel and patient interaction, despite words like virtual, remote, home, and siteless. Some clarifications:

Virtual Trials

Telemedicine and digital technology enable virtual trials. Patients can video chat with study coordinators, doctors, and nurses. Remote monitoring, data collecting, and patient assistance reduce the need for in-person visits. Some treatments, such blood testing and imaging investigations, involve personal interaction with health care specialists at local institutions.

Remote Trials

Remote studies are conducted in patients’ homes or local healthcare institutions. Study drugs, self-assessments, and remote monitoring or digital platforms are available to patients. Health experts advise, help, and monitor remotely. Some examinations or treatments may need in-person visits.

Home Tests

Patients’ homes are used for home trials, reducing travel. Health care experts can remotely prescribe study drugs, facilitate self-assessments, and collect data. Home health care professionals or visiting nurses may help patients during the study and perform essential procedures or evaluations at home.

Siteless Trials

Siteless trials further decentralize by removing the need for a trial location. Instead, people interact with health care providers online and trials are done remotely. Health care providers can gather and analyze data in patients’ homes or local health care institutions.

Health care providers supervise and support patients in decentralized studies. Physical interaction with health care providers is decreased but not eliminated, especially for in-person examinations and interventions. Decentralization aims to simplify trial participation while retaining health care experts’ monitoring and care.

Eliminating Decentralization Challenges

As McKinsey notes: Decentralizing clinical trials presents new difficulties to an industry known for long cycle times and conservatism.

Life-saving medications are delayed by the difficulty of enrolling and finishing trials. Biopharma firms spend over $70 billion on worldwide trials, yet patient enrolment is delayed and usually behind projections.

Sponsors often pick study clinics (“sites”) across the world and hope they can discover and enroll suitable patients. The venues are often inaccessible to qualified patients, and ineligible people are enrolling. Eliminating these issues requires predictable and accessible clinical trials.

Creating a large network of venues to enroll and get the study to patients is crucial. Digital tools are helping get more patients, but there are still numerous obstacles. Patients must first accept this new paradigm. Second, smaller firms must learn a new recruitment methodology.

Decentralized Clinical Trials Improve HealthCare Ecosystem

Decentralizing clinical trials improves the healthcare ecosystem by improving patient-centered care, expanding access to experimental treatments, fostering collaboration and knowledge sharing among providers, generating real-world data and evidence, streamlining processes and reducing costs, and promoting innovation and technology adoption.

Decentralization improves healthcare by moving trial activities to patients’ local health care settings. It broadens patient participation in studies, improving diversity and generalizability.

Health care practitioners collaborate more, exchanging knowledge and improving treatment. Decentralized trial data shows treatment efficacy in real life.

Patients and sponsors gain from streamlined processes and cost reductions, allowing research. Innovative technology are adopted into ordinary health care through decentralized trials, improving patient outcomes and care.

Decentralized clinical trials improve the health care ecosystem through patient-centeredness, access, cooperation, real-world evidence, efficiency, cost savings, and technical innovation.

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