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Clinical Trials

Clinical Trials

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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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...

Blinding

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Related Experiment Video

Updated: Sep 9, 2025

E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy

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Recruiting and Consenting Decentralized Clinical Trial Participants-Learnings from the Trials@Home RADIAL

Bart Lagerwaard¹, Linda Rutgrink², Danny van Weelij³

¹Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.

Clinical Pharmacology and Therapeutics

|September 4, 2025

Summary

Decentralized clinical trials (DCTs) face recruitment hurdles. Research databases were effective for recruitment, but the eConsent process had significant drop-off, highlighting the need for simpler remote consent methods.

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Area of Science:

Clinical trial operations
Digital health technologies
Patient recruitment strategies

Background:

Clinical trials face participant recruitment challenges due to logistical burdens.
Decentralized clinical trials (DCTs) aim to mitigate these barriers by bringing trial activities closer to participants.
Online methods are increasingly used for recruitment and consent in DCTs.

Purpose of the Study:

To explore recruitment strategies in a decentralized clinical trial setting.
To evaluate the implementation of remote electronic informed consent (eConsent).
To identify barriers and facilitators for DCT participant enrollment and remote consent.

Main Methods:

The RADIAL trial, a Phase IV study in type 2 diabetes mellitus, utilized decentralized methods across six European countries.
Recruitment involved online campaigns (ads, social media) and research database outreach.
Remote consent incorporated eConsent, telemedicine, eIdentification, and eSignatures.

Main Results:

Online recruitment yielded low pre-screener completion and enrollment rates.
Research database outreach was highly effective, contributing 7 of 8 decentralized arm participants.
A significant 69% pre-screening drop-off occurred at the consent stage; 11/15 participants completed eConsent successfully.

Conclusions:

Tailored recruitment strategies and simplified remote consent processes are crucial for DCT efficiency and accessibility.
Online recruitment requires optimized targeting and keyword strategies.
Implementing remote eConsent systems can be resource-intensive and complex due to regulatory variations.