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The clinical industry is an extensive marketing consisting of lengthy clinical studies which form a crucial part of the drug development process. Within the clinical sector a large amount of research is carried out to determine the safety and efficacy of a new treatment before it can gain authorisation to be manufactured and allowed to enter the market.
In general clinical studies are broken down into 4 phases of drug approval, with each phase being treated as a separate clinical trial. If a drug satisfies all requirements to pass phase I, II and III, it will generally be given the authorisation of the appropriate regulatory body to be released into market. Phase IV are the post-approval/post-marketing studies of that particular drug.

Preclinical studies

Before a company can commence with clinical trial studies, they must first carry out thorough preclinical studies. These involve both in vitro tests as well as in vivo tests in animal species. The purpose of these studies, in the drug development process, is to determine how safe it is to proceed to trialing the drug on humans. It is thought that the data generated will provide adequate information on the safety and efficacy of the active substance. Preclinical studies include Pharmacology (looking at pharmacokinetic and pharmacodynamic properties of a drug) and Toxicology studies. Only once a new drug molecule passes the pre-clinical phase can it enter the clinical trial phases. These studies aim to limit the risk to human patients.

Human clinical trials involve 4 phases. Each of these phases has a different aim:

Phase I is concerned with conducting tests to confirm the safety of a drug. These tests, which are carried out on about 20-100 individuals, will determine how the drug reacts in the human body, as well as any side effects that may be experienced.
Phase II is focused on the efficacy of the drug and this is tested by conducting tests on a larger population, of approximately 100-300 individuals. These tests are carried out on individual who have the disease or condition. This phase can be categorised in to both IIa and IIb trials with the later being the more progressed experimental stage.
Phase III determines the effect of a drug for a specific therapeutic use. The scale of the tests is again increased and up to 3000 candidates may be used in phase III trials. This is the last round of pre-approval tests and here the drug is tested against a standard treatment, for the disease in question, with the aim of further confirming safety and efficacy. Around 80% of drugs that make it this far will pass phase III tests and manufacturers can seek approval to produce and sell the treatment.
Phase IV trials are also known as ‘post-marketing’ trials. Tests at this stage are on-going, and concerned with surveillance on adverse effects of the drug on patients, as well as benefits of the treatment. Any harmful demonstrations at this stage could result in the drug being taken off the market.
In the clinical industry it takes many years to take a product to license and a large amount of investment is required. The costs and duration will vary significantly depending upon the complexity of the compound and the therapy of the developing firm involved. As a rough idea for a newly discovered compound to be brought through to market it can require investment of around $100 million - $1 billion.

Please also read our page on Clinical Research for more information on this highly specialised field within this sector.

We are experienced and have a passion for supporting clinical professionals and would welcome anybody interested in exploring new roles in this field to get in touch to see how we can help you with you next steps.
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