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Samenvatting Lecture 5 - Clinical Trials and Clinical Development AM_1180 (AM_1180)
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Lecture 5International Council for Harmonization of Good Clinical Practice (ICH-GCP)
ICH and its guidelines: started out in 1990→ different guidelines needed to be
harmonized between countries (ICH). Intention is to harmonize Clinical Research
of the world. The writing parties are the Regulatory Authorities and Research
Based Industry, supporting parts were also included (WHO, EU free trade area
etc.), and originally only from EU, US and Japan. additional steering community
(SC) members→ multiple organizations added to it (ICH-GCP)
Different guidelines (QSEM):
● Q Topics – quality
○ Deal with manufacturing a product, creating a product from scratch with
quality (manufacturing a quality product).
● S Topics – safety
○ Needed to create a safety profile for products, are about preclinical
development. Need to know prior to administration to humans.
● E Topics – Efficacy (clinical trials)
○ There are 18 guidelines (no E13 guideline, so 17 in total). Separate guideline
for pediatric or geriatric trials.
■ E2: deals with safety reporting in clinical trials
■ E3: tells us how to write study report (end of our trials)
■ E6: GCP
■ E8: general considerations for clinical trials
■ E9: statistical principles for clinical trials
● M Topics – Multidisciplinary
○ Cover all other 3 or at least 2 out of 3 out of the other categories. Expectation
that M topics will increase and subjects in other categories move to M topics.
○ Example: in Q we have quality management, when ICH updated R2 they
included quality management (largely from Q11 overtaken) and made it into
an M-topic. M1 is about coding adverse events, and can only analyze
numerical data so events need to be coded so they can be compared!
MEDRA (medical dictionary of regulatory authorities) used to code adverse
events.
ICH coming of age→2015 was 25 years anniversary. It is a formal legal entity,
Switzerland is also included. Name change into International Council for
Harmonisation. Region expansion with Switzerland and Canada. The doors are
open for other countries to join. The latest country that joined was the UK, they
were no longer part of the EU, so they had to rejoin.
The US only works with CFR, which is based largely on ICH-GCP, they adhere to it because
it reflects our thinking.
GCP(E6), best guideline ever→ finalized in 1996, global application, they haven't
changed it over the past 20 years, only added things! R2 (Revision 2) addendum
only adds fully explainable content. Everything in there can be reasoned back to
knowing why we have it and what we want to get done.
, GCP, best introduction ever→ one page fits all, it is very concise. In the intro it tells
us that it is an International Ethical and Scientific Quality Standard, thus not a
guideline, but the bare minimum standard.
● Twofold objectives (what did we want to achieve by creating this?):
○ Unified standard
○ Mutual acceptance of the data as being credible when ICH-GCP is adhered
to. Getting acceptance of data to be used anywhere around the world by using
it as a unified standard.
● Twofold goal
○ Protection of the subjects (trial participants’ rights, safety and wellbeing)
○ Generating credible (verifiable) data
“Good Clinical Practice (GCP) is an international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that involve the participation of human
subjects.”
“Compliance with this standard provides public assurance (needed to gain trust) that the
rights, safety and well-being of trial subjects are protected, consistent with the principles
that have their origin in the Declaration of Helsinki, and that the clinical trial data are
credible.”
“The objective of this ICH-GCP Guideline is to provide a unified standard [...] to facilitate the
mutual acceptance of clinical data by the regulatory authorities in (the ICH regions).”
Using ICH-GCP→ glossary for standardization. Principles come from physicians. All about
responsibilities (3 parties), then about documents. Two most important documents (to
achieve objectives and goals of ICH) in trial are the protocol (enables unified conduct of the
trial, because they all are written the same way) and product information (Investigator's
Brochure, IB). Essential document is for example an audit trail (documentation of the
reconstruction of what events happened during the trial). If we cannot reconstruct what
happened, we cannot verify how the data is generated and whether the participants were
protected.
Chapter
1 Introduction
2 Principles GCP
3 Responsibilities of the EC
4 Responsibilities of the investigator
5 Responsibilities of the sponsor
6 Protocol
7 Product information / IB
8 Essential documents
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