Clinical Trials

 

 

 

 

Take your nutritional product sales to new heights with Clinical trials conducted by Fenestra Research

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 following each companies specific set of instructions.

 

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

 

Who can participate in a clinical trial?

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. 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.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. The clinical trial team can include doctors, chiropractors, naturopaths, nutritionists, social workers 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 following each companies specific set of instructions.

Some clinical trials involve more tests and visits than the participant would normally have. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

Risks

We do not take on products for testing if there is any chance that our test subjects could become ill or sick from the products. We offer only non harmful and non toxic products for testing.

What is a protocol?

A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Sometimes weekly or daily phone calls are made as to help maintain strict protocol guidelines for our testing companies. 

What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value and offers no measurable changes in our testing system. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of products or experimental treatment.

What is a control or control group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions: In Phase I trials, researchers test a experimental product or treatment in a small group of people (20-80), usually for a 30-day period,  to evaluate its safety, determine the most effective as well as safe dosage range, and identify side effects. In Phase II trials, the experimental study products or treatment are provided to a group of people (51-300), usually for a 6-month period, monitoring for new cellular changes in the measurements of the subjects that may not have been apparent in the Phase I trials and to further evaluate its safety and effectiveness. In Phase III trials, the experimental study product or treatment is given to large groups of people (100+) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental product or treatment to be used safely

 

Fenestra Research Labs © 2005