Clinical Trials --> Part 2

When doing a clinical trial or clinical research for pulmonary hypertension or most any disease, the patient cannot be too sick or actually too well but strong enough to endure the length of the process; procedure; or treatment that may be involved.

Choosing to participate in a clinical trial is an important personal decision (I guess the critters don’t have a personal choice or decision to make). A clinical trial (also called clinical research) is a research study in human volunteers to answer specific health questions. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition and there could be risks involved; be sure to ask many, many questions.

• There may be unpleasant, serious or even life-threatening side effects to treatment.
• The treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

As previously mentioned all clinical trials have guidelines 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. Before joining a clinical trial, a participant must qualify for the study. 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.

The clinical trial team includes doctors and nurses as well as social works and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial has been completed.

Merle
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