Descetraliced clinical trials: present and future

The COVID-19 pandemic has boosted the use of various digital health tools, including ePRO, eConsent, remote monitoring, artificial intelligence to accelerate recruitment, business intelligence tools to optimize the selection of centers (feasibility), telemedicine, telepharmacy, etc. This has made it posible to  develop Descentralized clinical trials, which have been shown to improve patient involvement and, thus, obtain results that are more transferable to real life

Currently, randomized and controlled clinical trials continue to be the gold standard of clinical research. These clinical trials, apart from  cointaining a sample of patients that cannot be extrapolated to the real population, due to the rigidity of the inclusion criteria (age, comorbidities, non-adherence, etc), and are designed to an analogic world, which generates an extra difficulty when externally validating the sample. Theremore, these tests always provide a plus complexity and slowness, which translates into high cost.

The availability and incresase in the use of new technologies within the healthcare field has led to an improvement in clinical research by facilitating the communication, recruitment, patient consent and the collection of data necessary to meet the objetives set by the research. The application of these in clinical research entails a decentralization (total or parcial), giving rise to descentralized (or mixed) clinical trials.

Descentralized clinical trials are those that are carried out using new technologies that allow physcial sites to be partially or totally suppressed. Therefore, they take advantage of digital technology to allow some (or all) aspects of clinical trials to be carried out from the patient’s home instead of in a doctor’s office. Descentralized clinical trials represent a great advance in terms of how the data is collected and processed.

New machine learning techniques also play a critical role in the use of these technologies, even helping the researcher to predict the appeareance of possible adverse effects in a trial.

Although new and even more innovative technologies are being developed, we present below the tools that are being implemented  in the clinical research sector in Spain:

Electronic patient-reported outcomes (ePRO)

The ePRO allows patients to answer questions and report,through a electronic device, their physical, social and emotional well-being during the development of the clinical trial. Various investigations have shown an improvement in the quality of the data and the comfort of the patient, with respect to communication on paper. In fact, a 15% growth in the use of ePRO in clinical trials is estimated to be carried out until 2025.

The use of ePRO technology in a clinical investigation study makes it possible to know, in real time, with greater accuracy and in greater numbers, different data, such as adverse effects, even act them more quiclky.

As patients have to use the ePRO tools from their own personal devices, they must be easily downloadable on any device (Android, iOS). On some studies, patient may receive digital devices from the investigator. For example, a smartwach can be used with specific apps that report an increase in blood glucose, blood pressure, oxygen saturation, heart rate, etc.

At first, the implementation of ePRO involves an initial investment, but its use significantly reduces the final cost of the trial, and, moreover, the data obtained are of higher quality and statistical significance.

Electronic consent (eConsent)

Informed consent is a document that must be signed by the participant in any clinical trial. The regulatory agencies have issued of requeriments so that it can be done using an electronic device (médium) for signing the document (eConsent), which replaces the paper signature. Different suports can be used, such as video, animation, graphics, images, podcast and links to web pages.

The general requirements are usually:

  1. a. Give a copy to the patient
  2. b. The patient must be informed about the clinical trial
  3. c. The digital signature panel must contain: the name of the patient, the signature and date of the signature. It must also include the reason for signing (review, approval, etc.)
  4. d. The investigator must verify the identity of the patient. In addiction, if electronic signature devices are used, they must incorporate different systems to prevent forgery or impersonation.

Naturaly, all information (data, subject identity, study participation and personal information) will be restricted access, and  confidenciality and segurity will be ensured in the eConsent electronic system.

In this regard, more modern segurity techniques can be used, such as the zero trust model. This model is based on a strict identity verification process, which generates a security framework that requires only authenticated and authorized users and devices to access applications and data. At the same time, it protects these applications and users against advanced internet threats.

The use of these descentralized trials poses several limitations:

a. Retention rate could be lower: while remote participate provides added convenience for the patient, not having face- to- face visits could make it more difficult for patients to continue in the clinical trial.
b.  Possibility of modifying the primary objectives: if the switch from traditional clinical trial to decentralized is to be made, the primary objectives could have to be redesign.
c. Need for extra verification and validation: verification and validation of the conclusions reached from the analysis of the results are often needed in order to process the data.
d. Need to apply data exchange standards: data exchange standards must be applied between the different types of used devices, in order to assure that the data is proccessed at same way.

These limitations should be addressed in the coming years from the following approaches:

  • a. Increased sophistication, refinement and variety of technologies to ensure optimal data quality,
  • b. Increased verification, validation, justification and ease of use of these tools.
  • c. Exchange of data between regulatory agencies and clinical research acotrs (sponsor, monitors, investigators) to support the inclusion and recognition of these tools.
  • d. Improvements in data analysis, integrating digital conclusions and clinical data obtained through all digital tools, including artificial intelligence and machine learning.

The future of clinical research passes, as in all sectors, through its digitization. With the use of new digital technologies some of the limitations of centralized clinical trials (slowness, cost, etc), can be corrected and the quality of life of patients during the trials can be improved.

At Alpha Bioresearch, throughout 2021, we have worked on implementing new tools with the aim of meeting the times with which we commit to our clients and, therefore, be able to control the costs of the tests. We have focused on the critical points that can increase time and costs, which are, fundamentally, the selection of centers, recruitment and monitoring.  To this end, we have adquired and developed Business Intelligence tools, that will make it easier for us to select centers (feasibility) and therefore  will ensure recruitment in really competitive times as well as ePRO which will allow us to facilite monitoring and comfort of patients and researches.

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