What is Clinical Research?

Clinical Research is a term used to describe research which involves a patient and is organised by a healthcare professional. Clinical Research includes the testing of new medicines, medical devices or vaccines but can also be used to look at new combinations of existing treatments.‌‌

In addition to the testing of medicines, Clinical Research includes the comparison of blood and tissue samples of healthy people with those of sick people and the collection of medical data from patients with specific conditions which can be used to observe patients’ progress and responses to differing treatments.

‌Email crfg@nuigalway.ie to express an interest in becoming a participant in clinical research.‌

What is a Clinical Trial?

A Clinical Trial is a research study to answer specific questions about a new medical treatment (medicine/drug, medical device, new therapies, vaccines), or new ways of using known treatments. Clinical Trials (also called medical research and research studies) are used to determine whether such new treatments are both safe and effective. Carefully conducted Clinical Trials are the fastest and safest way to find treatments that work in people.

Why participate in a Clinical Trial?

‌Participants in Clinical Trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. 

What are the different types of Clinical Trials?

Interventional trials (also called treatment trials) determine whether new treatments, new combination of drugs, new ways of using known therapies or new approaches to surgery or other therapies are safe and effective. These trials might ask a participant to take an experimental new drug or undergo surgery.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals or lifestyle changes.

Observational trials address health issues in large groups of people. Trial participants may be asked to answer questions about their family histories or give blood samples, but they do not receive treatment for their diseases.

Screening trials test the best way to detect certain diseases or health conditions. 

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Who can participate in a Clinical Trial?

All Clinical Trials have rules about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a Clinical Trial are called ’inclusion criteria’ and those that disallow someone from participating are called ’exclusion criteria’. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.‌

Some research studies seek participants with illnesses or conditions to be studied in the Clinical Trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

Why participate in a Clinical Trial?

People participate in Clinical Trials for a variety of reasons. Volunteering for research studies can give participants access to promising new drugs long before they are available to the general public. Although there is always a chance that a new treatment will prove to be disappointing, there is reason to believe that it will be as good as, or better than, current treatments. Every effort is made to ensure safety and the care from a physician during the course of the study is highly controlled and monitored.

People who take part in Clinical Trials become part of a network of Clinical Trials carried out around the country and the world. Anyone considering participating in Clinical Research should talk about it with their doctors and medical care givers. They also should ask about the credentials and experience of the individuals and the facility involved in the study.

How are you protected if you take part in a Clinical Trial?

Every person participating in a medical research study, must sign an informed consent form that explains the research study, the foreseeable risks, benefits, other appropriate treatments, and where to find further information. It also explains one's rights as a participant in the trial. If at anytime a participant is not comfortable with the trial, they have the right to withdraw. Also, confidentiality of records and data are assured.

 

Please click on this link for further information on clinical trials: http://takingpartinaclinicaltrial.blogspot.ie/

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