All You Need to Know about Clinical Trials
What is a clinical trial? What phases does it have and who can participate in it? In this article, Avrio Biopharmaceuticals will give answers to these questions and help you feel more confident when deciding whether to take part in one of them.
What are clinical trials?
A clinical trial is a study of new drugs, as well as new ways to prevent, detect or treat diseases using volunteer people. When a new medicine is being studied, it is usually unknown whether it will be useful, harmful, or will not differ from existing alternatives. The task of a clinical trial is to determine whether or not the drug being studied is effective, and whether the new treatment is safe.
Who conducts clinical research?
Clinical researches are funded or sponsored by various organizations. Most often, sponsors are pharmaceutical companies – drug developers, but doctors, foundations, medical institutions, and community groups can also play this role.
A researcher is a doctor or group of doctors from clinical centers where research is permitted. A research team is also involved in a clinical trial, which may include doctors, nurses, social workers, and other healthcare professionals.
Why participate in clinical trials?
People take part in clinical trials for various reasons. For some, the motive to participate in the study is the opportunity to contribute to the development of new methods of treatment and, thus, to help other people recover.
Most people with complex long-term illnesses believe that clinical research is an opportunity to receive the best treatment, giving hope for a cure when existing methods fail. Thanks to participation in clinical trials, patients receive free access to innovative drugs, modern diagnostics according to world standards, and supervision from highly qualified specialists and additional medical care.
Who can participate in clinical trials?
Clinical trials are conducted according to a plan known as a protocol. Each clinical trial has specific requirements for who can participate, and all of them are listed in the protocol.
One of the reasons that you are not allowed to participate in a clinical trial may be the inconsistency of the set of criteria by which participants in clinical trials are selected.
The factors that allow someone to participate in a clinical trial are called “inclusion criteria.” Those who exclude from the participants or do not allow their participation are called “exclusion criteria”. These criteria are based on such factors as age, gender, type of disease, its stage, previous history of treatment and other diseases.
Phases of clinical trials
First, preclinical studies are conducted in laboratories in which drugs are tested on cages and animals. Then, the most promising experimental drugs are allowed at further stages of a clinical trial.
Are patients paid for participation in the trial?
Usually, only participation in phase I studies is paid when the drug is tested on healthy volunteers. At other stages, the financial incentive is excluded, so that the decision on participation is truly voluntary and independent. Some studies may cover the cost of parking, transportation and food. If the participant receives any payment or compensation for participation in the clinical trial, then this will necessarily be stated in informed consent.
Where to find a clinical trial?
There is only one resource, used to search for clinical trials conducted in the United States – www.clinicaltrials.gov – the international registry of clinical studies of the US National Institutes of Health. This resource is useful for more detailed and important research information.
Tags: clinical trials, drug production, health professions, quality drugs
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