Are Decentralized Clinical Trials The Future Trials?
Decentralized clinical trials leverages communications, telemedicine, AI, digital tools, and other technologies as a way to help recruit a more broadly representative patient population by gender, ethnicity, age, geography, income, and more.
DCTs, often called “virtual” monitoring studies or “remote” trials, are distinct from traditional clinical trials.
Decentralized clinical trials use “virtual” methods like
- telemedicine
- sensory-based technology
- home visits
- wearable medical devices
- patient-driven virtual healthcare interfaces
- direct drug and material delivery to patients’ homes
- community labs
- digital consent
- digital data collection
- remote monitoring, and diagnostics
Decentralized clinical trials have a combination of digital technologies and participant-centered designs. We can use a hybrid technique that still requires some physical site attendance or execute a decentralized clinical trial remotely.
In a fully decentralized clinical trial, patient and study staff are not directly involved in participant enrollment, medication administration, or data gathering on trial outcomes.
DCTs widely use traditional designs with decentralized patient or subject contacts and clinical trials for drug approval.
The need for face-to-face interactions between researchers and participants is lessened or eliminated in these investigations. Due to the epidemic and substantial historical technology breakthroughs, researchers have several options to apply this experimental technique.
How is a decentralized clinical study organized?
The assessment of the risk
An extensive risk analysis forms the foundation of a decentralized clinical study. It is essential to have a Risk-Based Quality Management (RBQM) approach that enables you to identify risks early on, monitor them, and offer insights.
To determine the kind of decentralized solution required for your clinical trial, we will employ a comprehensive RBQM approach.
Study logistics and patient focus
Any decentralized approach must prioritize the patients. Participation, security, and logistical considerations are also important factors to consider.
Remote approval
We have consulted IRBs to develop remote informed consent processes that adhere to legal requirements. Without this strategy, decentralized clinical research cannot get off the ground.
Online applications and recruitment procedures
During the feasibility and qualification phases, conversations with the clinical sites on the digital administration of enrollment and recruiting are necessary.
Throughout the site activation period, there should be continuing talks with clinical sites and any vendors (if employed) to confirm that clinical study sites are ready to start recruitment and enrollment activities as soon as they are accessible.
Use of telemedicine
In a decentralized study, to evaluate the subject’s safety, there are many tools available. During a telemedicine visit, the clinical site staff speaks with the patient via phone or web conference to go through modifications to the patient’s medication schedule.
Home Health Care
We have established home healthcare programs that pair patients with licensed medical professionals for in-person evaluations. The patient selects a convenient time and location for the appointment, and the home health care provider performs safety checks like blood collection and vital sign assessment and evaluation while they are there.
Lab Drawings
It’s vital to employ a local laboratory as a choice for some blood collections. By allowing blood draws to be carried out at a lab closer to the patient’s home, we can lessen the load on the patient. We can also work with a vendor who assists patients in gathering blood, urine, saliva, and stool samples at home and sending them directly to the lab for analysis.
Shipments of investigational products (IP) made directly to patients (DTP)
IP can be sent straight to patients’ homes through delivery services like home delivery or courier services. Shipping partners employ a controlled temperature shipper and temperature monitoring technology to guarantee that IP keeps a necessary temperature while the product is in transit.
Off-Site Inspection
Several off-site monitoring techniques are available to meet the demands of specific dispersed clinical research.
1. Specific risk-based monitoring levels and procedures
2. off-site surveillance
3. Verification of specific location data (TSDV)
Depending on the risks identified throughout the RBQM process, the present status of your clinical trial or program, and the ease of access to your clinical sites, we can select the optimum combination of these options.
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Centralized monitoring and data visualization
Remote clinical data evaluation is a necessary component of any decentralized system. The clinical data are centrally monitored to identify patterns, including information pertinent to site management activities and data about safety concerns. We can quickly identify significant quality and risk indicators, track them throughout the research, and provide timely information to support you in a decentralized clinical trial with the help of centralized monitoring technologies.
Update study plans and protocols.
Throughout your trial or program, be careful to update your research plans and procedures to keep track of potential changes to your decentralized strategy. In addition to ensuring compliance, updating protocols will result in correct data that supports endpoints.
Utilizing digital technology in decentralized trials
Decentralized clinical trials’ usage of digital technologies is vital. The US-FDA refers to the device as “digital health technologies,” or DHTs.
Any device used to remotely, continuously, or irregularly collect data from trial participants is referred to as a DHT. DHTs are frequently sensor-based systems that record information about behaviour or physiology.
DHTs (PROs) record clinical outcome assessments (COAs), performance outcomes, and patient-reported outcomes electronically. When we collect data electronically, we refer to COAs, PROs, and PerfOs as eCOAs, ePROs, and ePerfOs.
Not all DHT is FDA-approved or cleared for a particular usage. Instead, as part of a clinical investigation, we use some digital tools. The FDA states that DHTs used in clinical research wouldn’t require approval or authorization.
The Medical Device Development Tool (MDDT) Qualification Program, which the FDA oversees to assess whether a DHT would typically be appropriate for use in clinical development programs, has long been interested in this topic. Using an FDA-approved digital tool will help us lower the risk involved with the development process.
We can reduce the risk associated with the development process by implementing digital technology that has received FDA approval.
Information on electronic medical devices
After recruiting participants for the clinical research, we must collect data as part of the procedure. Clinical trials’ digital data are;
- Data from electronic medical records
- Samples of living things
- Statistics and health information
- Photos and results from patient reporting using a smartphone or tablet
Digital biomarkers
It is possible to objectively gather and evaluate measurements of physiologic, pathologic, anatomical, behavioral, social, or activity features as a sign of typical biologic processes.
Safety monitoring
Researchers can identify adverse events or ones that are situation-specific and unlikely to happen during a study visit by employing digital technologies to capture data in real time.
The speed at which we identify and report adverse and safety incidents impacts how quickly we conduct clinical investigations.
Data security (privacy and security)
Privacy, safety, and legislation are important factors to consider when we use digital health technologies. Because of digital technology and remote monitoring, it is essential to use security measures to prevent data breaches during data management.
Advantages of decentralized clinical trials
- Decentralized clinical trials make research more accessible to people from a wider population who might not often participate in site-based clinical studies.
- Improved involvement, diversity, and better participant recruitment are advantages.
- Researchers have determined that the main advantage of decentralized clinical trials is the simplicity of participation, which allows for flexibility, necessitates fewer in-person study visits, permits passive data collection, and eliminates barriers like geographic factors, time restraints, and travel.
- Because decentralized research allows for more diverse and representative groups, trial results are more generalizable.
- Decentralized clinical trials enable the study of rare diseases with geographically dispersed patients, advancing our understanding of these conditions and maybe improving healthcare.
- They support the supply of remote medical care, the creation of pertinent patient-specific data, the quick response to clinical queries or worries, the capacity to monitor adverse effects, and the expansion of patient experience knowledge.
Recommendations from the FDA for decentralized clinical trials
- When the DHT possesses the features needed to make it simpler to use and interpret in clinical research, it is said to be “fit-for-purpose.” investigators must consider this.
- The proposed guidance emphasizes that while determining the rationale for using it in clinical research, investigators need to consider many factors.
- The privacy of the DHT is another essential element.
- We need to keep gathering data consistently.
- Take into account the DHT’s usability as well as accuracy.
- Check each endpoint.
- Informed consent: The FDA has already given guidance on how to take informed consent signatures electronically. Even though the advice is brief on the matter, the FDA did note that some tools require.
Conclusion
Clinical trial decentralization is a rapidly expanding area of study with many opportunities. The effectiveness, participant experience, and generalizability of clinical research enhance by taking advantage of technological improvements.
Despite its advantages, decentralized clinical trials have several disadvantages in patient safety, staff workload, and patient burden.
Researchers conducting clinical trials must confirm benefits to participants, staff, and research data. This information will enable future decision-making on centralized clinical trial applications.
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