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What are clinical trials and why do they matter?

Safety of medical trials in London

In general medical trials are considered safe with strict oversight procedures and ethical requirements aimed at protecting volunteers.

There are several international agreements and guidelines that all countries must follow to ensure the safety of drug trials. These include the Declaration of Helsinki and the ICH Harmonized Tripartite Guidelines for Good Clinical Practice.

There are also ethical considerations to ensure the people are respected and that the purpose of the study is for the good of all mankind. These ethical guidelines are there to ensure that poor, disempowered communities are not exploited. Clinical Research Organisations must make sure that their researchers and investigators are competent, participants must know both the risks and the benefits of the trial, the privacy of patients must be ensured and consent procedures must be followed.

Where patients with potentially life-threatening medical conditions agree to take part in a drug trial, ethical and safety guidelines require that all the benefits and possible harm be explained to them and researchers must make sure that patients who will be placed at undue risk be excluded from the study.

The safety of volunteers who take part in an experimental drug trial is monitored throughout the trial so that adverse side-effects can immediately be identified and managed. There are also strict guidelines about the dosages of experimental drugs that can be given to volunteers.

If a CRO comes to the conclusion that a drug has no real beneficial effect on volunteers, the clinical trial must be stopped. If risk exceeds benefit the parameters of the study must be amended or the trial must be stopped.

During each phase of the medical trials for a medicine, the pharmaceutical or bio-technology company will evaluate the safety and effectiveness to determine the benefit-risk profile of the medicine. If the risk exceeds the patient benefit, then the study will be changed or stopped completely.

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