Clinical Trials: How the Medical Products Are Tested and Approved

medical-researchClinical trials are an essential part of the development and progression of medicine and involve the testing of new medical therapies, which once passed can be used safely and efficiently in everyday practice. However, the road to approval is a long and drawn out one, with clinical studies of new drugs and practices taking anything from weeks to years to complete. But how do the investigational medicinal products we see in pre-clinical and clinical trials evolve into the drug products on the shelves of our local pharmacist or those prescribed to us by our GP?

Why are Clinical Trials Important?

Firstly, it is important to understand why a clinical trial is important when it comes to the development of medicine and health care. Essentially clinical trials aim to answer two primary questions - ‘is the treatment safe' and ‘does it work on humans'? Clinical studies also delve into a range of areas to ensure that all questions related to a proposed treatment are answered before the drug or process can become fully commercialised and available to patients either via prescription or over-the-counter.

Clinical trials can help answer the questions surrounding the intervention of certain diseases or conditions by analysing their development and the medicines or lifestyle factors that affect this. Studies can also be instrumental in the diagnosis of a condition and the contributing factors that put patients at risk of development or progression of certain diseases, conditions or syndromes. In addition to this, studies and clinical trials can facilitate the improvement of quality of life for people suffering from a certain illness or condition.

Pharmaceutical firms have been providing clinical trial supply since the mid-20th century, but trials have been used as far back as the 1700s, ensuring the evolution of medicine. These earlier clinical trials led to the discovery of antibiotics and other drug products still widely used in modern medicine.

The Road to Trial

The study of new drugs and processes begins long before the clinical trial. Pre-clinical studies take place in the laboratory before the treatment is formerly tested on humans, and defines whether it is safe to test further. Pre-clinical stages involve the use of cell studies to answer this all-important question and to measure the effects that the proposed product or process will have on human or animal cells. Following this initial stage, the research must then be approved before it can be clinically tested on humans. To complete the application, researchers must provide pre-clinical results and clinical manufacturing information explaining how the product is made and describing its other physical traits. The protocol for the clinical study itself must also be carefully outlined, with any risks highlighted in detail.

Technology Transfer

The backbone of a clinical trial is the technology transfer, which is a detailed process whereby the equipment, processes and methods involved in the development of the proposed product or practice are fully validated. Using a number of procedures the development of the drug can be successfully scaled throughout the research, development and production phases ready for full commercialisation.

The Phases of Clinical Trials

A clinical trial consists of a number of phases; the first entails the testing of the proposed treatment on a small group of people (up to 80 individuals). During the second phase a larger group is tested, with the third stage resulting in a group of up to 3,000 people being given the new drug or treatment. At each of these stages, the safety of the treatment is evaluated, dosage is determined and any side effects are pinpointed. During the fourth phase, additional information is gathered to determine the benefits and risks of the treatment based on research collected from each group.

Through the various stages of pre-clinical and clinical trial the bridge from discovery to commercialisation can be created, resulting in you getting better and more innovative medical treatments and surgical procedures.

This article was written and published on behalf of SCM Pharma, an independently-owned contract drug manufacturing service. SCM provides pharma, biotech and healthcare firms with the resources they need to successfully develop medical processes and products.

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