Derriford

Clinical trials, also known as drug trials, are one of the final stages of a long research process into the success and efficacy of new or existing drugs, and will ultimately decide what pharmaceutical companies can and cannot be put out on the market. The trial only takes place once a significant amount of research has been carried out. If all drugs were trialled before research had been conducted, this would waste a lot of time and money.

Why are clinical trials important?

Clinical trials are important because they allow scientists and technicians to test the safety of drugs, as well as their efficacy. The trials are carried out under strict supervision and the results are used to determine which drugs are used for which patients, the recommended dosage levels of new drugs, possible drug interactions (some drugs should not be used with other drugs) and side-effects of drugs. The main purpose of the trial is to ensure that the drug is safe for public consumption.

Clinical trials are really important because they allow scientists to develop new drugs and monitor their success or failure. Drugs are the most common form of treatment and help to ease symptoms and save many people’s lives each year, and without the trials the safety of new drugs could not be ensured and risks of side-effects and complications would be unknown.

Often clinical trials are performed to compare new drugs to existing forms of medication. The trials help to ensure that doctors can offer patients the most effective treatment at all times.

What is involved in the clinical trial process?

Clinical drug trials often involve volunteers. The pharmaceutical companies or research teams will ask certain individuals to trial a particular drug, based on the nature of the medication and the illness it may be used to treat in the future.

In the early stages of the trial process, a small number of healthy individuals are usually used to test the drug. They are given a dose of the drug and their condition is then monitored by staff; they will be usually be given a blood test as well as other tests, including heart rate, blood pressure and body temperature. The drug is trialled on healthy individuals to see how long it stays in the individual’s system, how it interacts with other medications and food and how much of the drug can be taken without unpleasant side-effects developing.

The clinical trial will then move onto the next phase and a larger group will be tested; the first group is usually around 20-300 and then a larger group of up to 3,000 will be tested. The aim of this phase of the trial process is to determine the effects of the drug on a larger group of individuals and establish suitable dosages.

Informed consent

Everyone who participates in a clinical study must give their consent. Participants must be advised about the process of the trial and informed about the possible risks and complications before they agree to do the trial. Participants have the right to leave the trial at any time.

Pharmaceutical manufacturers, also known as drug or pharmaceutical companies, are responsible for the manufacture of drugs and medications. These are drugs that can ultimately make a marked to people’s lives, or even save millions of lives. In the manufacturing of pharmaceutical medicines great emphasis is placed on cleanliness to prevent contamination, more so than many other manufacturing industries due to the nature of the work.

Manufacturing license

In order to manufacture drugs in the UK, pharmaceutical companies must have a license. To obtain this, companies must apply to the Medicines and Healthcare products Regulatory Agency. The MHRA has the power to suspend or remove a license from a manufacturing company.

The manufacturing process

The manufacturing process is usually governed by a set of guidelines, which is referred to as ‘Good Manufacturing Practice’. This is not a set of instructions or protocol but acts as a guideline for manufacturing companies. In the USA, GMP is regulated by the FDA (Food and Drug Administration), and in the UK most of the guidelines are covered under the 1968 Medicines Act. The manufacturing process in the UK is regulated by the Medicines and Healthcare products Regulatory Agency.

The guidelines are in place to ensure the manufacturing process is safe, clearly defined, effective, efficient and well-organised. Members of staff who are involved in the process should be trained and every effort should be made to ensure that they work in a safe environment.

The pharmaceutical industry has been around for hundreds of years. However, the nature of the industry has changed significantly over the years.

The earliest drug stores

The earliest drug stores, or pharmacies, can be traced back to the middle ages. It is believed that the first drug store opened in Baghdad, Iraq in the year 754 and stores then started to open across the Middle East and Europe. Drug stores gradually became more widespread and by the beginning of the 19^th Century, there were hundreds of stores across the world.

As pharmaceuticals become more advanced, large pharmaceutical companies started to form and marketing and distribution started to increase. Most of the major pharmaceutical companies were founded either in the late 19^th Century or the early 20^th Century. Initially, large pharmaceutical companies were founded in Germany, Switzerland and Italy but other European nations, including the UK, Holland and Belgium, soon started to develop strong pharmaceutical industries.

Drug development

Drug development has been in existence for many years but the industry really took off in the 1950’s in tandem with the development of specific scientific approaches, advances in technology and an increased understanding of the human body (most notably the structure and function of DNA). Major developments were made in the 1950’s and 1960’s. During this time, the oral contraceptive was launched and blood pressure drugs and heart medications were developed and marketed. This era also saw the introduction of psychiatric medication and drugs such as Valium came into existence.

During the 1970’s the drug industry really took off and competition between pharmaceutical companies intensified as stronger patenting legislation was introduced. Many of the smaller, independent firms folded and were taken over by large pharmaceutical companies. By the end of the 1980’s, a small number of large corporations held most of the power in the industry.

The industry changed considerably in the 1990s thanks to the introduction of the internet; the internet allowed consumers to shop around and order medication online. The internet also allowed drug companies to purchase raw materials online.

The modern pharmaceutical industry

The modern industry is heavily dependent on science and technology. Technology is advancing at a rapid rate and scientific research is instrumental in the development of new drugs. Research is ongoing and several new drugs are in development, though cancer remains the biggest challenge for professionals in the medical research field.

The introduction of the internet has enabled people to buy drugs without seeing a medical professional. Many other outlets are also available today, with supermarkets and high street pharmacies now selling both prescription and over the counter drugs.