For those of you that are new to the area of clinical trials I thought it may be useful to give a brief definition of them. The aim of a clinical trial is to establish the drugs effectiveness and potential side effects to see if the drug is worth bringing to market. As well as looking at what effect the drug has on a patient pharmacokinetic effects are also studied which are the changes a human body makes on a drug.
The main types of trials are:
Controlled trials: where the patients are split into two groups, a trial group and a controlled group. The trial group receives the new treatment and the controlled group gets the current treatment. The aim is to compare the treatments to see if the new one offers significantly better results
Randomised trials: patients are randomly selected by a computer and grouped together that way.
Blind trial: The patients do not know if they are receiving the old or new treatment.
Double blind trial: As well as the patients being unaware if they are receiving the old or new treatment the medical staff administrating the drugs are also unaware.
There are a number of phases involved in clinical trials. These are:
Phase I: this is the first stage in which dugs are tested on people. It involved working with a small number (up to 50) of people and seeks to establish safe dosages, admin methods and the effects of the drug
Phase II: again this is working with a small group and aims to narrow down the usefulness of a treatment for a particular manifestation of the disease. It also aims to confirm if they are able to move on to testing the drug on larger groups.
Phase III: This involves working with a larger group of people and examines the side effects of the drug and compares the new treatment to the current treatment.
Phase IV: At this stage you are now working with 1000s of people and are looking to prove the effectiveness of the drug
Once the trial is conducted any data that is collected is sent to the regulatory body for a benefit/risk assessment where a decision is made as to whether the advantages outweigh any potential drawbacks.
There is a whole host of challenges that those involved in clinical trials have to overcome in order to ensure that they bring the maximum number of drugs to market. I will be concentrating specifically on phase I clinical trials and will bring you some interesting content exploring successful early phase clinical design strategies in the coming weeks.