The Clinical Trials Process



Pharma IQ
10/20/2010

 

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Clinical trials play an extremely important role in helping pharmaceutical companies get their products to market. They are designed to ensure the safety and efficacy of new products before they are marketed to the public and they are needed for companies to be granted a licence for their drugs.

Approval has to be sought by the regulatory authorities in the individual countries where the pharmaceutical clinical trials are being conducted before they can begin. In the United States, this is the Food and Drugs Administration, while in the UK, the Clinical Trials unit of the Medicines and Healthcare Products Regulatory Authority is tasked with the responsibility.

Pharmaceutical clinical trials can be carried out either in-house or by clinical research organisations (CRO), which are also sometimes known as contract research organisations.

The Association of Contract Research Organisations claims that, in the year 2010 alone, revenue for the CRO industry is expected to be $20 billion (£12.6 billion). The organisation's members carried out more than 9,000 trials in 115 countries in 2008.

The various stages of pharmaceutical clinical trials

Initially, those looking to perform a pharmaceutical clinical trial will have to apply to the relevant regulatory authority to prove that they have given due consideration to the rights, dignity, safety and wellbeing of human subjects.

All pharmaceutical clinical trials conducted with the European Union (EU) must meet the requirements of the EU Clinical Trials Directive, as must all trials conducted outside the EU which involves products intended to be marketed within its boundaries.

Guidance surrounding clinical trials includes submission of details to the relevant authorities and ethics committees, requirements of safety monitoring and reports of adverse effects and inspections by competent authorities.

Once permission has been granted for a pharmaceutical clinical trial to take place, phase I tests begin where a very small number of healthy people are given the drug to establish if it is safe for human use.

Good clinical practice guidelines

All pharmaceutical clinical trials which use human subjects are required to meet good clinical practice (GCP) guidelines. GCP guidelines state that the treatment of human subjects must be the prime concern of all those conducting pharmaceutical clinical trials, and should be placed above "the interests of science and society."

The guidelines require detailed information to be provided, showing that they are "scientifically sound" and results are reported and recorded in the correct way.

Harmonisation of these guidelines allows for sharing of data from pharmaceutical clinical trials across authorities in the United States, the EU and Japan. The guidelines are also accepted by authorities in Australia, Canada, the Nordic countries and by the World Health Organisation.

GCP guidelines also require that all staff involved in clinical trials have the correct training for their role. All medical decisions in regard to human participants must be made by qualified professionals

Phase II trials involve larger numbers of people with the illness to see if the product acts as an effective treatment.

If both these phases are successful, phase III trials will take place on large numbers of patients with the illness, where the product's efficacy is compared to others on the market or, on occasion, to a placebo drug.

A full pharmaceutical clinical trial can take in excess of a decade to complete, after which an application must be made to the relevant licensing authority for approval to market the product.

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