The Clinical Research Industry is concerned with establishing the safety and efficacy of medicines and devices that are produced for human consumption. In order for a drug to be deemed as being safe, it must go through extensive clinical research and pass all phases of clinical trials. Only then can the manufacturer claim that the drug is both a safe and effective treatment for the condition it is intended for.
Clinical research covers several elements of the drug development life cycle, ranging from the initial lab-based research involved in drug design, through to pre-clinical testing on animals, followed by clinical trials on human subjects and beyond into the treatment and aftercare of patients. Clinical trial careers can be exciting and very diverse, providing good opportunities for science graduates wishing to enter the Pharmaceutical or Biotechnology industries.
Clinical trials are just one of the many areas of clinical research. The clinical industry consists 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 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.
Clinical Trial FAQs
What are 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 is to determine how safe it is to proceed to trialling 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.
What are the 4 phases of clinical trials?
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.
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 latter 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.
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