Clinical trials play a major role in the development of drugs of any kind. In fact, no medicine or drug would be allowed to enter into the market, if the medicine has not been assessed, monitored, and checked via such clinical trials. They are a necessary part of drug research and they are also mandatory under the law. Clinical trials are basically research carried out by Clinical Research Units, or ‘CRUs’ to check the efficacy and safety of any drug, prior to it being released and put on the market for consumer usage. Clinical trials are also carried out on existing drugs that have been modified to bring them up to par with the latest innovations in the pharmaceutical industry.
Types of Drugs being Tested
The trials are conducted on various types of drugs before they are sent for approval to the authorities:
New Drugs – These have to be tested extensively before they can be sold in the market. The efficacy of the drugs, the side-effects if any, the length of the treatment, and the safe dosage range – establishing this data this is all part of the drug trial.
Modified drugs – These are checked to assess side effects, and performance effect gained by enhancing the ingredients within them, often also to check if they are effective in treating other ailments. Comparison of Drugs – Quite often, clinical trials are held to compare different types of treatment for diseases to analyse why something works and why other processes do not work.
How can clinical trials help?
Clinical trials can help healthcare professionals and pharmaceutical companies in many ways:
- They check the effectiveness of the drugs.
- The potential side-effects of the drugs are identified.
- They determine how a treatment is affected by food and drink.
- They are used for testing new medical equipment such as pacemakers.
- Clinical trials are also used for testing blood tests and scans to check how well they detect and diagnose illnesses.
Rules and Regulations
Clinical trials are always held in controlled and secured environments. They are closely regulated by the authorities and trained medical professionals are on hand to monitor volunteers. All the results of the trials are carefully analysed before a conclusion is arrived at. The set of rules, known as the trial protocol, are clearly laid down and have to be adhered to at all levels. Before the trials begin, an application must be submitted to the MHRA who will award a Clinical Trials Authorisation if they approve.
Role of Volunteers
The volunteers are the most important component of any clinical trial. In fact, no clinical trials are possible without people. They are chosen carefully, based upon their health, age, and sex. It is mandatory that they should have full knowledge of what the trial entails and that they sign an informed consent form before the trial begins. They receive constant supervision during the duration of the trials and are paid transportation costs and remunerated in accordance with the length of the trial. Volunteers can receive anywhere in the range of 500 to 3000 for their contribution to the trial process.
Importance of Clinical Trials
It is clear that without clinical trials, no new drug can be released in the market. They provide the basis of testing all new innovations in the healthcare industry, and are also the best way to check the effectiveness of new treatment methods before they are made available via prescription.
- License: Image author owned
- License: Image author owned
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