Empowering patients empowers results - PMLiVE


One area that has great potential is in portable devices. Regardless of whether they are worn on the wrist or as an adhesive plaster on the body, AI embedded functions enable the devices to measure the heart rate or metabolism of patients remotely. Others can test for antibodies or blood pressure.

A patient's daily activity can even be monitored for a more complete view from posture to sleep pattern. These devices are connected to each other via secure networks via the cloud, so doctors can view and analyze the data in real time.

It is important to realize that there is no one-size-fits-all approach to this. Different experiments require the introduction of different technologies, all of which can be mapped using digital strategies. Supporting decentralized trials through an ecosystem of technologies like video calling and electronic reminders can certainly improve patient compliance in trials.

From ensuring participants are taking the right medication at the right time, to asking them to record developments in an electronic diary, moving to digital solutions can help improve patient compliance and morale throughout the process. As patient friendliness improves, protocol adherence and compliance also improve, resulting in more accurate results and faster development of new and safer drugs.

A better way to manage the data

Ultimately, success depends on interoperable data being captured and combined with medical research from every phase of the process. This allows researchers to provide rigorous evidence of patient benefit, as well as possible side effects, which can later be presented to regulators.

However, this is usually not an easy process. It is critical that all data - including any side effects, number of patients who discontinue treatment, frequency and method of data collection - are accurately recorded, logged and analyzed. This requires a Herculean coordination of the pharmaceutical industry, doctors and patients in order to generate valid evidence.

This is made difficult by an industrial model that is too complex and fragmented. For example, there are no universal standards for medical devices. Devices that measure heart or respiratory rates may require calibration and some understanding.

In addition, companies in the past have developed digital solutions that best suit their purposes, making it more difficult to share data with systems already established in the healthcare sector. Both problems present a real challenge when it comes to effectively managing the various platforms and data sources and ensuring the quality, security and protection of patient data.

A key incentive for decentralized studies is the collection of real data and real evidence that provides an assessment of the life of a study. The data is recorded continuously and in the context of the lifestyle and health habits of the participants - all in one overall picture.

Ultimately, by using different technologies in decentralized studies, more data can be collected from patients than in traditional location-based clinical studies.

Because these technologies can provide data directly from the source, such as handheld devices, they also reduce the need for additional data review, which can reduce the schedule and cost of clinical trials.

In addition, doctors can better monitor the situation of patients at home and alert them to health problems or side effects much faster.

It's a seamless process

Developing in-house solutions for decentralized clinical trials represents a significant departure from the current resources, skills and expertise available in large pharmaceutical companies. However, the benefits of implementing decentralized clinical trials quickly outweigh the challenges of reducing trial schedules and costs, and providing more accurate data.

To speed up these attempts, many startups and tech companies in the industry are actively working to find a solution. AI, machine learning, and cloud computing are one area, but there are other components that work in the background to ensure a seamless process.

Distributed general ledger technologies such as blockchain are used to minimize the distance between doctors and patients and to improve the organization and security of data collection.

Decentralized clinical studies are not only changing the pharmaceutical and health industries, but also the regulatory and control authorities. Increased quality control and storage requirements, as well as up-to-date standard operating procedures, are important benefits that can ultimately reduce the time it takes to get life-saving drugs to market.

Shielding against future interference

The decentralization of clinical trials is part of the ongoing modernization of the industry. In a risk-averse, highly regulated environment, change is often difficult. However, the pressures of the pandemic are giving way to greater innovation in the industry, and the benefits of remote devices are obvious.

Patient orientation is the key here. By incorporating convenience and flexibility into the clinical trial process, significant bottlenecks that the industry previously struggled will be removed. This translates into better levels of recruitment and engagement, and more accurate data monitoring.

With a view to the future, decentralized studies offer protection against major disruptions and ensure the continuity of operations and, above all, the improved delivery of life-saving drugs to patients.


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