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Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Preclinical Development: Overview

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Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform

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Addressing the Key Challenges of Decentralized Clinical Trials in Europe: Multistakeholder Perspective Delphi Study.

Carlos Murciano-Gamborino^1,2, Lina Pérez-Breva¹, Amos J de Jong³

¹Vaccines Research Area, Foundation for the Promotion of Health and Biomedical Research in the Valencian Region (FISABIO-Public Health), Avenida Cataluña, 21, Valencia, 46020, Spain, 34 961925948.

Journal of Medical Internet Research

|July 9, 2026

Summary

Decentralized clinical trials (DCTs) in Europe face challenges, but expert consensus identified key solutions. Recommendations focus on training, logistics, collaboration, and regulatory harmonization for better research frameworks.

Keywords:

Delphi method clinical research decentralized clinical trials digital health patient-centered trials stakeholder engagement

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Last Updated: Jul 12, 2026

Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform

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Published on: April 12, 2021

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Published on: January 12, 2018

Area of Science:

Clinical Research Innovation
Health Care Systems
Regulatory Science

Background:

Decentralized clinical trials (DCTs) leverage digital technology to improve accessibility and reduce participant burden.
Despite regulatory efforts in Europe, DCT adoption is hindered by operational, regulatory, and technological challenges.
Traditional site-based trials often struggle with recruitment and participant retention.

Purpose of the Study:

To identify and prioritize actionable solutions for DCT implementation challenges in Europe.
To gather multistakeholder insights addressing ethical, legal, and operational barriers in DCTs.
To inform the development of more inclusive and efficient decentralized research frameworks.

Main Methods:

A 2-round Delphi study involving 26 experts from March to May 2023.
Systematic inductive content analysis of 309 open-ended responses from Round 1 surveys.
Evaluation of 39 synthesized proposals using a 4-point Likert scale in Round 2, with consensus defined as ≥80% agreement.

Main Results:

High consensus achieved: 32 of 39 proposals met the threshold, 14 reached 100% unanimity.
82% of proposals were rated as "appropriate" or "very appropriate."
Key recommendations include professional training, validated logistics, improved local collaboration, regulatory harmonization, capacity building, and user-friendly digital tools.

Conclusions:

Expert-driven recommendations provide a roadmap for overcoming DCT implementation barriers in Europe.
Adoption of these recommendations can foster more inclusive, efficient, and sustainable decentralized research.
The study highlights the need for tailored solutions respecting national specificities within a harmonized European framework.