Regulations and Guidelines

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Clinical trial regulations can be confusing and unwieldy to researchers, in many cases they are enough to put potential researchers off embarking on clinical research. Therefore the intention of this section is to explain what regulations exist, where they apply and how to work through them in a sensible and pragmatic way to determine what is applicable to any given trial.

In this pilot version of this site there is a brief overview below about regulations with links and notes. Later there will be a comprehensive tool that will take the researcher through the design of their proposed trial and guide them in what is and is not needed and which regulations apply. The overall aim is to simplify and untangle the mass of different regulation and end up with trials that have applied what is needed in an appropriate manner relative to the relative risk of the trial, the vulnerability of the participants and the nature of the protocol’s design.

It would be beneficial to all if researchers could submit any relevant experience they have had either interpreting guidelines or specific areas they have found problematic to interpret and apply to their trials.

Over recent years there has been massive proliferation in regulations affecting the conduct of clinical trials. This began some time ago when the Declaration of Helsinki was written in 1964 by the World Medical Association (WMA) in response to a tightening of legislation following the Thalidomide incident in the 1960s. The implementation of the declaration resulted in the US Food and Drug Administration (FDA) having to reject trial data from other countries as they did not have the same ethics and safety standards.  This drove the harmonisation process led by regulators from Japan, Europe and the US and experts from the pharmaceutical industry that produced, in 1996, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) guidelines.

Predating ICH-GCP, the Council for International Organizations of Medical Sciences (CIOMS), produced its International Ethical Guidelines for Biomedical Research Involving Human Subjects in 1982. Revised in 2002, these guidelines are intended to guide lower income countries in applying the ethical principles that were laid out in the Declaration of Helsinki.

Another set of international clinical trial guidelines was produced by the World Health Organisation in 1995. The WHO Guidelines for good clinical practice (GCP) for trials on pharmaceutical products were developed to provide a global standard for clinical trials. They were intended to complement existing regulations in those WHO member states that had already enforced clinical trials legislation or to provide a basis for new regulations in countries that had not.

However neither the CIOMS or WHO guidelines hold the force of law and ICH-GCP is now the global standard by which trials are run and has become a legal requirement of many countries.  

In Europe, the European Medicines Agency (EMEA), is responsible for the evaluation and supervision of medicines for human use. The EU Clinical Trials Directive 2001/20/EC and the EU Good Clinical Practice Directive 2005/28/EC comprise the legislative framework for clinical trials in Europe.

You can visit a database of the specific regulations and guidelines for many countries (the Global Regulatory Requirements Database) by clicking here. 

You may also be interested in The Global Health Training Centre's Free eLearning course on Good Clinical Practice.

Click here for relevant tools and templates, including a Regulatory Binder Table of Contents