• Vk
  • LinkedIn
  • Youtube
X7 Research
  • News
  • Registration strategy and Сonsulting
    • Budgeting
    • Registration strategy development
    • Study feasibility
    • Vendor selection
    • Data search and analysis
  • Clinical trials
    • Outsourcing CRAs in Russia and the EAEU
    • Development of medical documentation and biostatistics
    • Monitoring
    • Data-management
    • Patient home visits
    • Bioequivalence study
    • Therapeutic equivalence studies
    • Clinical trials of medical devices
  • Registration
    • Audit of the registration dossier
    • Bringing the registration dossier in compliance with the requirements of the EAEU
    • Conversion of registration dossier into XML format
    • PIL readability user testing
    • Translation of the Registration dossier
    • Turnkey registration
  • Post-authorization clinical studies
    • Phase IV studies
    • Non-interventional studies
    • Investigator-initiated studies
    • Post-authorisation safety study
    • Marketing research
  • Pharmacovigilance
    • QPPV in the EAEU
    • Safety monitoring of medical devices
    • Building a pharmacovigilance system
    • Safety in clinical trials
    • Pharmacovigilance audit
    • Pharmacovigilance contact person
  • Therapeutic expertise
    • Clinical trials in Oncology in the EAEU
  • Contact
  • EnglishEnglish
  • Menu

EMA revised guideline on first-in-human clinical trials

13.09.2017/in News /by Evgenii Tkachenko

The European Medicines Agency (EMA) has reconsidered its guidance on phase I clinical studies with the purpose of providing the organizations involved in conducting clinical trials to find out the potential risks for trial participants and therefore minimize it.

First-in-human trials have always been the crucial step in medicines development. The drugs which have previously been tested only in vitro, in vivo and ex vivo are administered to people for the very first time. However, people who take part in these clinical trials, normally healthy volunteers, cannot avoid an element of hazard as the ability of scientists to predict the effects of a newly developed drug on people is always limited. Though there have been registered fairly few cases when trial participants experienced serious health effects.

When researchers design early clinical trials they should always put safety and well-being of trial participants first. That’s why the new revised guideline is focused on the sponsor’s obligation to outline the uncertainty related to preclinical testing steps and to describe how the potential hazards that may result from this uncertainty will be considered in the design of the trial. What’s more, the new guideline says that this approach must be supported by a well-documented scientific rationale.

The revision of the guideline takes into consideration the fact that in the past 10 years trial protocols have become very complex. This led to the fact that now these protocols often include different parts within a single clinical trial protocol, with the aim of evaluating, for instance, single and multiple dosing regimens, food interactions, or testing the medications for people of different age.

The guideline puts special attention to the calculation of the starting dose to be used in humans, the following dose elevations and the criteria for determining the maximum dose. These aspects are considered to be the most important in terms of identifying the ways to stem and manage risks for trial participants. The guidance provides researchers with the criteria to terminate a study. It is also mentioned that the periodic review of emerging data with special attention to safety information and the management of adverse events are extremely significant.

This guideline has been revised in collaboration with the European Commission and the representatives of the Member States of the European Union through the EU Clinical Trials Facilitation Group (CTFG).

Source: centerwatch.com.

Share this entry
  • Share on Twitter
  • Share on WhatsApp
  • Share on Pinterest
  • Share on LinkedIn
  • Share on Tumblr
  • Share on Vk
  • Share on Reddit
  • Share by Mail

YOU MAY ALSO BE INTERESTED IN

Publications
Readability User Testing of Package Information Leaflets (PIL) in EAEU
Read More
Publications
Remote clinical trial monitoring
Read More
Publications
Post-authorization studies of drug safety in Russia
Read More

RUBRICS

Registration strategy and Сonsulting

Clinical trials

Registration

Post-authorization clinical studies

Pharmacovigilance

LATEST PUBLICATIONS

  • Corrections to clinical trial documents due to COVID-19. Russian experience.
  • WHAT IS BIOEQUIVALENCE
  • THE VOLUME OF RUSSIAN PHARMACEUTICAL MARKET 2016-2019

Tags

bioequivalenceClinical trials in the CISfeasibilitymonitoringRadiopharmaceuticals

CONTACT

2 + 2 = ?

This contact form is deactivated because you refused to accept Google reCaptcha service which is necessary to validate any messages sent by the form.

PRIVACY

Use of this site constitutes your consent to our Privacy Policy.


SOCIAL RESPONSIBILITY

X7 Research’s primary responsibility is to help our clients in bringing medicines & products to the market efficiently and safely.

The Best CRO for Clinical Trials | Full-service Global CRO — X7 Research

The Best CRO in Pharma | Clinical Research Organisation — X7 Research

The Best Contract Research Organisation (CRO) | Trusted CRO — X7 Research

The Best Clinical Research Organisation (CRO): Full Service CRO | X7 Research

The Best CRO in Research | Trusted CRO for Your Trail — X7 Research

The Best Clinical Trial Company | Global Full-service CRO - X7 Research

The Best Pharma CROs: Clinical Trials for Drugs | X7 Research

The Best CROs Company: Clinical Trials with Global CRO — X7 Research

The Best Pre-clinical CRO: Safety Assessment With X7 Research

The Best Clinical Development | Trusted CRO for Your Product: X7 Research

The Best Biostatistical Consulting: Statistical Services | X7 Research

The Best Pharmacovigilance Consulting Services | CRO — X7 Research

Feasibility in Clinical Trials: What is a Feasibility in Clinical Trials?

Clinical Study Trials: What are Clinical Study Trials?

Category
Strategy and consulting
Clinical trials
Registration
Post-authorization clinical studies
Pharmacovigilance

Registration strategy and Сonsulting
Registration strategy development
Budgeting
Study feasibility
Vendor selection
Data search and analysis

Clinical trials
Development of medical documentation and biostatistics
Monitoring
Data management
Patient home visits
Bioequivalence study
Therapeutic equivalence studies

Registration
Audit of the registration dossier
Dossier eaeu
Conversion of registration dossier into xml format
Pil readability user testing
Turnkey registration

Post-authorization clinical studies
Phase iv studies
Non interventional studies
Investigator initiated studies
Post authorisation safety study
Marketing research

Pharmacovigilance
Building a pharmacovigilance system
Safety in clinical trials
Pharmacovigilance audit
Pharmacovigilance contact person

Blog
Contacts

© Copyright 2010-2023 - X7 Research. All rights reserved.
Dupixent is effective in asthma treatment FDA revises the regulations of stem cell therapies and regenerative medicin...
Scroll to top