The Clinical Development category encompasses the stages of testing new therapies in human subjects. This includes the design and execution of clinical trials, spanning from Phase I (safety and dosage) to Phase III (efficacy and monitoring of adverse reactions). The focus is on generating robust clinical evidence to support regulatory approval and ensure the new treatments are safe and effective for patients. This category also involves optimizing clinical trial methodologies, patient recruitment strategies, and regulatory compliance. The aim is to streamline the clinical development process to bring new therapies to market more efficiently and responsibly.
Useful links
The ICH has many relevant and informative guidelines on clinical development. The list below is only a selection. We recommend to check the ICH website for further information.
- ICH E8(R1) - General considerations for clinical studies
This document provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used. - ICH E6(R2) and follow-up documents
The European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies to reach its opinions on the authorisation of medicines. Although clinical trials are authorised at national level in the European Union (EU), EMA plays a key role in further developing the EU as a competitive centre for innovative clinical trials, and in maintaining IT systems for the coordination of clinical trials. The list below links to overview pages were you can find relevant guidelines and other information.
- Clinical efficacy and safety guidelines
Overview of guidelines specific for targeted system of the investigational product under study (cardiovascular system, nervous system, antineoplastics and immunomodulating agents, etc.) - Clinical pharmacology and pharmacokinetics guidelines
Overview of guidelines, points-to-consider and reflection papers concerning pharmacology and and pharmacokinetics. - Clinical Trials Information System (CTIS): online training modules
The Central Committee on Research Involving Human Subjects (CCMO) authorizes clinical trials at the national level in the Netherlands. Clinical trials are not allowed to start without a positive decision of this committee. The list below is only a selection of useful information. We recommend to check the CCMO website for further information as it contains all the information you need to know to compose a Clinical Trail Application (CTA) and apply for approval.
- Overview of medical research in the Netherlands (OMON) by CCMO
- Quick guide on the rules and procedure of the CTR
- From start to finish: Clinical trial application under CTR
- Dossier for CTA: research dossier Part I and research dossier part II
- Pilot scientific advice CCMO
- As of Monday 24 February 2025, the new template clinical trial agreement is available on the CCMO website. Also find this guiding document for this new template.
Want to know about clinical research studies and information about their results visit:
- ClinicalTrials.gov (worldwide)
The purpose of ClinicalTrials.ogv is to provide information about clinical research studies to the public, researchers, and health care professional - Clinical Trials Register (EU)
The Clinical Trials Register allows you to search for protocol and results information on: i) interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC and ii) clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU links
- Clinical trials - European Commision
- Clinical Trials Coordination and Advisory Group (CTAG): This expert group advises the European Commission (Directorate General for Health and Food Safety (SANTE) i) in drafting new legislation and policies.
- Expert group on clinical trials (CTEG)
- Search for clinical trials (EMA) and the new EMA Clinical Trial Map of Europe