Physicians, nurses and other researchers follow strict rules when conducting clinical trials. These rules protect the interests of the patient and remove any bias from the study. The best available research design is known as a randomized, controlled, double-blind clinical trial. That is a mouth full, but let us tell you how it works:

• Patients who have agreed to participate in the study are assigned to one of the treatment options by random choice, like a flip of a coin.

• When a new medication is being studied, it may be compared to an existing medication, or to a placebo. A placebo is a harmless substance with no medical effect. It is manufactured to look identical to the medication being tested.

• Neither the patient, the nurses nor the physicians know whether the placebo or the study medication is being used. This is called a placebo controlled double-blind study.

• The study medication is given to one group; the placebo to the other. Patients in both groups are watched carefully during the study and the reactions of both groups recorded.

• At the end of the study, the reactions to the treatment are compared to see if one group responded better than the other. This information is used to determine if the new medication was effective in treating the disease. Only after the trial is completed do researchers find out which patients were in which group.

It is YOUR decision to participate in a clinical trial. You will be part of the trial only if you (or your designee) give informed and written consent. A consent form often is long and detailed, because it is important that you have all the information needed to make an informed choice. The consent forms contains the following:

• an invitation to be part of the research project

• an explanation of why the study is being done

• a statement about the company or agency that is funding the study

• detailed information about treatment effects (good and bad) that may occur if you become part of the study

• information about other treatments available, should you choose not to be part of the trial

• identification of who will have access to and be able to use the information from the study

A Randomized, Double Blind, Phase 3 Study Of The Efficacy And Safety Of XXXXX In Subjects Requiring NSAID Treatment.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Determine Whether, In Patients With Type 2 Diabetes At High Risk For Cardiovascular And Renal Events, XXXXX, On Top Of Conventional Treatment, Reduces Cardiovascular And Renal Morbidity And Mortality.

A Multi-Center, Randomized, Double-Blind, Placebo And Active Controlled, Parallel Group, Dose Range Study To Evaluate The Efficacy And Safety Of XXXXX Comparatively To XXXXX, And To Evaluate XXXXX To Placebo After 8 Week Treatment In Patients With Essential Hypertension.

A Long-Term, Open Label Safety And Efficacy Study Of XXXXX In Subjects With Fibromyalgia.

A Randomized Evaluation Of Long Term Anticoagulation Therapy Comparing The Efficacy And Safety Of Two Blinded Doses Of XXXXX With Open Label Warfarin For The Prevention Of Stroke And Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: Prospective, Multi-Centre, Parallel-Group, Non-Inferiority Trial.

Most people have questions when they are invited to take part in a clinical trial. Here are some of the more frequently asked questions and the answers to those questions:

Why Can't I Choose which Treatment I Get.... What Group I'm In?
The purpose of not knowing what group you are in and being assigned to a group on the basis of chance is to ensure that the results of the study reflect only the treatment and not other factors.

The fact that the medical staff does not know which group patients are in ensures that they do not make patient treatment decisions based on the likelihood of a better result, even subconsciously. It also removes any emotional involvement on the part of the patient, which could affect the outcome of the study as well.

It gets back to the question of bias. When all those immediately involved in the study are blinded to the treatment groups, the risk of a biased result is virtually eliminated.

How Can I be Sure a Study is Safe?
All clinical studies conducted are carefully reviewed by an Institutional Review Board. A detailed study plan is examined by the IRB to help ensure that the study is designed properly and that the findings are likely to benefit patients. The committee also reviews existing information about the new treatment to ensure that side effects are acceptable and the potential benefits of the study outweigh the potential risks.

Only those studies the IRB has approved will be conducted. The risks and benefits of the study are shown in detail on the consent form.

Who Conducts These Clinical Trials?
The principal investigator has overall responsibility for the study and plays a major role in conducting and planning how the study will run. The study coordinator helps the principal investigator in running the trial.

The coordinator and principal investigator are responsible for screening patients to be involved in the study and obtaining their consent. The progress of a participating patient is followed closely by the coordinator, one of the study physicians, and the physicians and nurses caring for the patients on a day-to-day basis.

Does My Own Physician Know About the Study and Do You Need His or Her Approval?
A patient's physician will be made aware of the study. A patient will not be considered for the study if his or her physician or other physicians involved in his or her care do not wish the patient to be enrolled. The patient's physicians are kept fully briefed by study personnel during the trial.

What If I Don 't Want To Be Part Of The Study?
Your participation is voluntary. You may decline without any change to your medical care.

What If I Change My Mind?
You may end your participation in the clinical trial at any time.

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