Introduction
Clinical Research Benefits Us All
Medicines need marketing authorisation prior to being released into the general market for sale to patients and before being prescribed by healthcare professionals.
Clinical trials are undertaken prior to this release and allow the safety, efficacy and quality of the product to be tested. Prior to a clinical trial being undertaken the medicine will have been tested in non clinical conditions to assure the quality and the non-clinical safety of the product. One should note however that not all clinical trials involve medicines. The intervention may involve a device rather than a medicine. Not all clinical trials are affected by the new EU Directive. Only trials involving an intervention with a medicinal product are affected.
The aim of clinical research is to discover the causes of human diseases
and how they can be treated equally importantly, how disease can be prevented
in the first place. When clinical researchers set out to answer questions
about different diseases, they need to use information gathered by examining
patients. They may also compare blood and other tissue samples from patients
with samples from healthy people. Sometimes the research will involve patients’ records,
or information that people give during health and lifestyle surveys. A key
branch of clinical research is clinical trials to test new treatments for
safety and effectiveness. Sometimes these treatments will stem from laboratory-based
science that scientists have translated into potential innovations in healthcare.
Clinical trials aim to show the benefits and risks of new drugs or treatments,
usually by comparing them with the standard treatments in use. During a clinical
trial, the treatments being compared are given to patients or healthy members
of the public. The researchers then carefully observe and record any differences
in their effects on the trial participants over time.
What is a Clinical Trial?
A clinical trial is any investigation in human subjects intended to discover
or verify the clinical, pharmacological and/or other pharmacodynamic effects
of one or more investigational medicinal product (CTIMP), and/or to study
absorption, distribution, metabolism and excretion of one or more CTIMP
with the object of ascertaining its safety and/or efficacy. (Ref
MHRA)
What is an Investigational Medicinal Product (CTIMP )?
An investigational medicinal product is a pharmaceutical form of an active
substance or placebo being tested or used as a reference in a clinical trial,
including products already with a marketing authorisation but used or assembled
(formulated or packaged) in a way different from the authorised form, or
when used to gain further information about the authorised form. (Ref
EU Directive 2001/20/EC Article 2)
Commercial or Non - Commercial Research?
Research can generally be classified into commercial and non- commercial
research.
The majority of clinical trials will involve a commercial pharmaceutical
company and hence is classified as commercial research. The new legislation
(EU Directive) was expected to have its main impact on non-commercial research,
where perhaps monitoring and controls along with documentation and audit
trials were not so developed.
Non –commercial research covers:
- 'in house' studies
- studies set up by non-commercial organisations (e.g. NHS bodies, Charities or Universities)
| Other healthcare professionals who are involved in the supply and administration of investigational medicinal products need to ensure that they consult their local clinical trials pharmacist and that have received the appropriate education and training as recognised by their professional body, prior to them initiating a clinical trial. |