Decentralized Clinical Trials – The Future

Decentralized clinical trials are enhancing efficiency and participation, thanks to advances in clinical research, digitization and technological advances.

Imagine a cancer patient living in a remote area, struggling with the logistics of participating in a potentially life-altering clinical trial. Decentralized clinical trials (DCTs) offer a solution. Using technology to bring study visits, medication delivery, and monitoring directly to the patient, DCTs break down these barriers, transforming access and hope. To enhance the patient experience and maintain ongoing studies, biopharmaceutical companies and contract research organizations are embracing decentralized clinical trials (DCTs). It is already clear that life science enterprises benefit from DCTs’ virtual approach. This translates to significant advantages within the clinical trial landscape, including easier patient and site participation, lowered costs, and streamlined data integration.

Implementing decentralized clinical trials

Clinical development will take time and effort, no matter what strategy is used. To reduce the overall burden of clinical trials, it is vital to find and use solutions that can be changed and used on a larger scale.

Brick-and-mortar study sites are commonly used in traditional clinical trials, and these locations act as the hub of clinical development within a specific region or geographic location. In most cases, a designated investigator team is responsible for carrying out the testing at the satellite facilities or the direct patient tests with patient-reported outcomes. This methodology calls for in-person observations, examinations, and assessments to be carried out at several research locations.

The most important factors that should guide the design of decentralized clinical trials are the requirements of the studies and the patients’ experiences. In a hybrid clinical trial, for instance, some patients would go to a physical location for an ECG/EKG or a tumor biopsy, while other patients might participate electronically. In this scenario, as well as others like it, patients often use an electronic patient-reported outcome (ePRO) solution, such as a smartphone app or software solutions, in addition to instruments for electronic clinical outcome assessment (eCOA).

Patients participating in treatment cycles that usually need site visits can now have a patient kit or medicine sent to their homes if they participate in specific research programs. To determine insulin or cortisol levels, for instance, clinical study researchers who need samples of patients’ blood or saliva can send those samples to patients as sampling kits. Patients will then gain access to a digital platform or a virtual healthcare provider who will instruct them on how to carry out the tests remotely using telemedicine. In addition, participants are allowed to communicate their concerns and data with the study coordinators.

Bringing patients’ care closer to their homes has several advantages but presents many challenging obstacles. When conducting a decentralized study, one of the most complex treatment problems that must be solved is the coordination of home-based treatments that call for the expertise of a trained medical practitioner. When a broad population from several different sites is included in the clinical study, it might make overcoming these problems much more difficult.

Focusing on the patient is essential, as it has never been more important than it is right now. Developing scalable, flexible, and intelligent solutions will be vital for long-term success, even though the decentralized clinical trial approach is both distinctive and essential.

Keeping up with the evolving needs of clinical studies with a conformable procedure

The notion of a “decentralized clinical trial” is that researchers can recruit and treat patients at multiple locations to enable a wider geographical distribution of subjects and help detect treatment effects earlier, since the timeliness of treating patients. A robust protocol framework and study structure that uses DCT solutions as an integrated alternative must be designed and implemented for future study designs.

One of the most complex parts of a clinical investigation can be coming up with a strong protocol and study design that can be changed if needed. Many businesses are ready to turn their traditional clinical research methods into fully registered and integrated decentralized clinical trials (DCTs) that use streamlined technology to make the whole trial more effective and easier to manage. Assume sponsors, CROs, and IT firms collaborate. In that case, they can use digital and direct-to-patient solutions that collect data from a distance and reduce or eliminate the need for in-person meetings.

When moving from a traditional research method to a digital or decentralized one, the protocol framework and study structure must be changed to fit the new method. No matter where the study occurs, it helps to have a design that can be changed to fit the problems and changes that clinical trials face.

Additional requirements must be met to carry out a successful decentralized clinical trial. These requirements are based on things usually taken into account in clinical studies. They include schedules for patient visits, methods, and rapid drug formulations or approvals for investigational new drugs. In the case of DCTs, the study’s leaders need to evaluate how sustainable remote or tele-visits are, how to keep track of changing quality and regulatory standards, and how to guarantee that the clinical study will be safe regardless of the location. How clinical study methods are carried out can also differ, which is another factor that can affect clinical results. These variances can bring unpredictability into crucial endpoints of the study, which must ultimately be taken into consideration in the calculations for the sample size and the plans for analysis and monitoring.

To get reliable patient results and consistent patient-reported outcomes, the study must stay on track from when it starts until the last patient takes part. Despite the difficulties, the most important thing to do to make progress is to become more adaptable and efficient, cut administrative burdens, and prioritize patient-centred care without sacrificing the quality of clinical studies or data integrity.

Maintaining patients’ interest within a digital setting

With the help of decentralized clinical trials, patient participation and retention have significantly increased. However, patient engagement and retention remain challenging aspects that must be carefully examined as part of the study design process.

Many things can change the number of patient visits and the quality of the reported data. These problems could become a burden for patients and cause more people to drop out of clinical trials, which can cause results to be delayed or wrong.

Even with the use of direct-to-patient and digital/virtual solutions, DCTs continue to face a significant challenge regarding the retention of their patients. There is no need for direct patient-provider engagement when patients may complete paperwork linked to the protocol on their own time and place, such as online surveys, eFeasibility assessment, eConsent, patient journal forms, and other similar documents. After that, clinicians can use a virtual technology platform to collect the data and check it as it is being collected. When figuring out how much stress a study puts on patients and whether or not it’s possible to collect patient data remotely, it’s essential to look at the study’s overall goal and how complicated it is.

Biopharma companies and large CROs need to work together on digital technology and unified solutions to help patients feel safe and at ease. For instance, a decentralized clinical study might run with participants in different regions. GPS and RFID technologies, which automate reporting through a research app based on location data provided by patient devices like mobile phones, allowed the study’s managers to detect these areas. Therefore, as long as patients are in a region that can support the system’s GPS and RFID technologies, investigators can automatically record the time, date, location, and type of medical encounter that took place with a patient.

In addition, predictive analytics, which is based on earlier studies, can assist in anticipating the actions of patients, which can have a positive effect on enhanced data collecting and patient retention. The ability to monitor patients remotely allows tracking of these trends, which can assist investigators in identifying anomalies before they occur. For instance, it is anticipated that a research site will have a risk rate of adverse events equal to thirty per cent. Although it is currently at 15%, projections show it will eventually reach or even exceed 30%. A sponsor could engage with investigators and patients to avoid problems before they arise by utilizing predictive analytics and artificial intelligence.

Patients’ participation, retention in the study, and receiving quality care are essential success factors. Although decentralized clinical trials frequently improve patient enablement, there are still many factors to consider and obstacles to surmount in terms of patient retention and patient participation. It is very important to consider patient burdens when planning the study, making the protocol, and choosing the equipment for the study.

Establishing digital solutions that are suitable for DCT standards

A direct, patient-centric home healthcare model that efficiently satisfies the interests of sponsors, study participants, and investigators is possible only with the use of technology that is trustworthy and easy to use.

Clinical research is susceptible to being hampered. However, digital health solutions and unified platforms powered by more advanced technology are emerging as potential answers to the difficulties of decentralized clinical trials. Using technologies such as artificial intelligence and advanced analytics, virtual study capabilities, and various interoperability are considered superior alternatives for enterprises conducting clinical research. With these tools, researchers can speed up their work, improve the quality of their data, and get more patients and sites involved.

It is essential to have both a site portal and a patient portal to improve data quality, patient engagement, site engagement, and partnerships with sponsors. This is especially true for completing online surveys and feasibility and eConsent papers. Clinical research start-up management tools can help accelerate site selection and patient recruitment, despite the limitations of these solutions.

There are also options available that allow sponsors and CROs to enhance the patient experience, produce significant evidence during clinical studies, and get more value from the collected data.

Find out what data solutions and technological tools can help your decentralized clinical trials.

Researchers are more interested in employing biosciences technology to enable decentralized clinical trials or improve traditional trials. Sponsors are realizing that a more patient-centric approach increases the efficacy of studies. They are employing technology to deliver better care, be more sensitive to the needs of patients, and lessen the hassles both sites and participants face.
Even before recruiting patients, site teams and investigators can devote more time and attention to patients’ consultation and overall well-being if they use more advanced technology. Recent changes have made it easier for patients to participate in clinical research. For example, patients can now use community websites to find out more about the research before deciding whether to participate.
Patients do not need to travel to provide electronic consent or complete any other documentation because of improvements in technology. Even before the clinical trial has begun, they can raise questions or express concerns to the investigator, which helps develop a relationship between the two parties. Health professionals discovered that remote patients gave more consistent replies, leading to better reporting.

A new benchmark for the industry

There is nothing unusual about conducting clinical studies in a decentralized manner. Studies that are shown in a format that is either entirely or partially virtual have become the new norm in this field. They make it easier for sponsors, researchers, and patients to do their jobs by improving data quality and helping researchers do their jobs more efficiently. Users can start with a basic digital clinical study solution, being flexible, and adding more advanced features as their clinical operations and goals progress.

In the end, clinical investigations made possible through digital technology give flexibility. They can shift and pivot when the circumstances change and lessen the regulatory documentation and logistical issues connected with such changes. Most crucially, it is possible to achieve all of these objectives while maintaining an unwavering concentration on enhancing the quality of life of patients and minimizing their suffering in general.

Maxis Clinical Sciences’ professionals have extensive experience with the decentralization process of clinical trials. We provide all the necessary tools and technology to ensure the studies go off without a hitch. To ensure that clinical studies get the most benefits possible at each stage, our experts employ strategic collaboration with Sponsors to perform clinical data analysis and trial report preparation and provide a tailor-made solution for clinical trial studies.