Frequently Asked Questions
A clinical trial is a research study utilizing human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.
Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the “standard treatments.” Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.
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. It is no exaggeration to say that a large share of the credit for current treatment successes belongs to the people who participated in the clinical trials conducted over the last decade.
For trials, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in studies are treated safely.
All clinical research plans—known as “research protocols”—must go through a rigorous process to ensure that the research is not only scientifically sound, but also safeguard’s study volunteers’ health and human rights. All research studies conducted in the U.S. must abide by the ethical principles found in the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and other strict federal guidelines. Clinical trials also enlist the support of Institutional Review Boards (IRB) to protect participants’ safety. An IRB is an independent group made up of scientists, doctors and other people. IRBs play a critical role in protecting the interests of study volunteers by ensuring that any risks to their safety are minimized and study volunteers’ rights are fully protected.
While study volunteers’ safety is paramount, there may be risks, both known and unknown, associated with taking an experimental treatment. When considering participation, it’s critical to understand the known potential side effects and weigh these with any potential benefits. Moreover, as a study volunteer, its crucial to know what to do if a complication should arise.
Mountain View Clinical Research will make sure that all patients are well informed. In addition, Mountain View Clinical Research makes every effort to keep the patient’s primary care physician informed of the patient’s participation and progress.
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. These criteria can include current medications, age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Criteria are used to identify appropriate participants, promote participants’ safety, and ensure that researchers learn the information they need.
Participants receive a physical examination and their medical histories are reviewed by a research staff member once they are enrolled in the study. The volunteers’ health will continue to be monitored during and after the trial. A detailed description of what’s expected of volunteers will be outlined in consent forms along with specific clinical trial information. Mountain View Clinical Research believes strongly that clinical research participation should be in collaboration with the volunteer’s primary care physician. Therefore, significant health information such as lab results will be shared with the volunteer’s primary care physician as deemed appropriate.
No. The trials conducted by Mountain View Clinical Research are provided at no cost to the volunteer. Volunteers may be reimbursed for time and travel. The details of covered costs will be explained to you at your first visit and each volunteer will be given a copy of the “Informed Consent” which outlines reimbursement in detail.
Travel just means your visits to doctor’s offices for appointments. There is no additional travel involved.
Informed consent means that the volunteer agrees to participate in the trial under conditions explained by the investigators. However, the volunteer is not legally bound to remain in the trial, and may leave at any time without penalty. It is hoped that volunteers will remain in the trial so that study results are not skewed by dropouts.
Informed consent requires the study’s researchers to thoroughly inform volunteers about:
- The study's plan
- Treatment to be given during the trial
- Tests that will be carried out
- Follow-up procedures after the trial
Once signed, all Mountain View Clinical Research volunteers will be given a copy of their Informed Consent.
Yes. The study data is collected based on a patient #. Volunteers sign a HIPAA consent that lets them know who has access to their personal health information.
After a volunteer concludes his/her participation in a study, Mountain View Clinical Research will be happy to see if a volunteer qualifies for a new study. There is usually a short waiting period required between the ending of one study and participation in a new study. Just let the research staff know if you are interested in continuing your participation.
Clinical trials vary in length. Some are as short as a few weeks or as long as a few years. You will be fully informed about how long you need to participate, and you may quit at any time though it is hoped that volunteers will remain in the trial so that high quality data can be provided.
In the past, most drug testing had been done on white men. This means that some groups, such as African Americans, Hispanics/Latinos, American Indians, Asians, Pacific Islanders and women, had not always been included in the tests done on drugs. But sometimes drugs work differently in these people than on white men. So FDA wants people from many different groups included in these studies.
Mountain View Clinical Research is required to file a 1099-MISC with the Internal Revenue Service for payments to any individual who receives a total amount of $600.00 or more in a single tax year. These payments may be accumulated from participation in several projects, and may be in the forms of cash, check, or non-cash subject incentives. Therefore, complete documentation must be collected from the subject at the time of payment.
The IRS requires that Mountain View Clinical Research obtain the volunteer social security number for the correct reporting of compensation.