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Clinical trials definition

Given the increased rate of paid clinical trials, there has been a marked interest in participating in these trials. However, before committing, it’s important to have an understating of what a clinical trial actually is.

Clinical trials are a component of clinical research. They are the very essence of all advances in medicine. These trials assess new ways to prevent, identify and treat diseases. Treatments could include new medications or combinations of medications, newly designed surgical procedures or devices, or new applications for existing treatments.

The goal of all clinical trials is to find out if a new medical intervention, such as a test or a treatment, works, and if it is safe. These trials can also examine other aspects of care, such as improving the quality of life for people who have been diagnose with chronic illnesses.

Why do people participate in clinical trials?

People choose to participate in clinical trials for several reasons. Some of the most common reasons people claim to participate in trials include:

  • To help others by determining if new approaches are effective and safe
  • To contribute to the advancement of science
  • To receive treatments and the additional care and treatment that a clinical trial staff offers
  • As a means of making money

Statistic: Number of patients who took part in clinical trials for pharmaceutical company Roche from 2009 to 2016* | Statista
Find more statistics at Statista

What exactly is clinical research?

Clinical research can be loosely defined as medical research that involves other people. Participants volunteer to take part in trials that are conducted with extreme precision in an effort to ultimately uncover more advanced ways to treat, prevent, identify and understand the nature of diseases that affect human beings.

Clinical research involves trials that rest out new therapies and treatments. They can also involve long-term natural history studies, which reveal pertinent information regarding the development and progression of diseases.

The protocol used for clinical trials

Clinical research and trials are conducted according to a specific plan of action, which is known as a protocol. The protocol for research and trials is painstakingly designed to protect the health and well-being of participants’, and to find answers to specific questions pertaining to research.

The protocol used for a clinical trial will describe the following;

  • Individuals who are eligible to participate in a trial
  • Details regarding the tests, procedures, examinations, medications and dosages that will be used during the trial
  • The duration of the study
  • The type of information that will be gathered

Clinical studies are headed by principal investigators, who are often doctors. A research team will monitor participants involved in a clinical trial regularly in order to determine the safety and effectiveness of the results.

Sponsors of clinical trials

Clinical trials are sponsored or funded by several different groups. These sponsors can include organizations, medical foundations, medical institutions, physicians, voluntary groups, pharmaceutical companies, and even federal agencies.

In order for an individual to participate in a clinical trial, he or she must provide informed consent. Informed consent refers to the process of sharing key details about relating to a clinical trial with prospective participants before they decide to move forward and take part in the trial. Essentially, informed consent allows those who are interested in taking part in a trial determine whether or not they want to move forward and participate.

The details of the study are explained by the research team. An informed consent document that highlights the details of the study, including its purpose, the expected duration, the procedures that will be involved, and who can be contacted for further information. Additionally, this document also fully explains the potential risks and benefits that are associated with the clinical trial. Participants are free to remove themselves from the study, or to refuse specific treatments or tests at any time during the trial.

Types of clinical trials

There are various types of clinical trials. Some of the most common types include:

  • Preventative trials, which aim to find better ways to prevent disease in groups that have never contracted a disease, or to prevent a disease from reappearing. These trials may include vaccines, medication or lifestyle changes.
  • Natural history studies, which offer invaluable information regarding how diseases and human health progress.
  • Diagnostic trials, which assess new tests and procedures that can be used for diagnosing specific diseases or conditions.
  • Screening trials, that examine the best way to identify specific diseases or health conditions.
  • Quality of life trials, which explore and measure methods that can be used to improve the comfort and the quality of life of patients who have been diagnosed with chronic illnesses.

Clinical trial phases

All clinical trials are conducted in different phases. Each phase of a trial outlines a different purpose and assists researchers with finding answers to their questions.

The phases of clinical trials are as follows:

  • Phase I – Medications and treatments are tested on a small group of people for the first time. This phase evaluates the safety of the medication or treatment and identifies and side effects.
  • Phase II – The drug or treatment is given to a larger group of people in order to determine its effectiveness, as well as to further assess its safety.
  • Phase III – The experimental medication or treatment is given to an even larger group of participants. The effectiveness is conformed and side effects are assessed and are compared with standard or equivalent treatments.
  • Phase IV – Once the medication or procedure receives approval from the FDA and is made available to the public, medical researchers continue to track its safety and effectiveness in order to collect more information regarding the potential risks and benefits, as well as the optimal use.

Who can participate in clinical trials?

Various groups of people can participate in clinical trials. Some participants are completely healthy, while others may have been diagnosed with an illness. Individuals who do not have an illness are considered healthy volunteers, while those who have been diagnose with an illness are considered patient volunteers. Both types of volunteers are needed for clinical studies for a variety of reasons.

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