Questions Frequently Asked Pertaining to Clinical Trials

If you are considering playing a vital role in the advancement of medicine and medical technology by embarking on your first experience as a clinical trial volunteer, you most likely have a few questions about clinical research and the clinical trial process. For your convenience, the medical and research professionals at Velocity Clinical Research have put together a list of frequently asked questions and answers that may help…

 

What is a clinical trial?

First, if you are new to the entire clinical trial process, you may want a detailed explanation of what clinical research actually entails. Basically, new medication, vaccines, medical devices and other medical technology can only be made available to the general population after extensive laboratory research. Clinical trials are an important part of that research, which is used to determine the efficacy of treatments and ensure the safety of patients. Clinical testing often begins in animals and may involve years of research before testing progresses to humans and government approval is finally granted for use within the general public.

Once a drug or device is approved by the Food and Drug Administration for research and testing in humans, there will typically be four phases of clinical trials including the involvement of many volunteers and with the entire four phase process possibly lasting over the course of several years. Each of the four phases of a clinical trial is considered a separate trial and is scrutinized by the Food and Drug Administration before progressing to the next clinical trial phase. 

How do clinical trials work?

You might also want some specifics detailing the inner workings of clinical trials, so here is an example of the way your clinical trial might work. As a clinical trial volunteer, you may be assigned to a particular study group. Some study groups may receive investigational treatments, while others may receive placebos (placebo – a harmless, inactive medicine or procedure that has no therapeutic effect and is used as a control in testing) or treatments already approved for use. During the clinical trial, neither the volunteers nor the medical and research staff members are aware which patients receive which. The purpose of this is to keep testing, observation and medical attention completely objective regardless of what treatment they receive. The health of clinical trial volunteers is vigilantly monitored during the course of and often after the clinical trial.

What is required of a clinical trial volunteer?

Clinical trial participants may be required to submit to a physical examination and a medical history review before actually being enrolled as a clinical study volunteer. For participation as a volunteer within a clinical trial, there is no insurance required. All study procedures, treatments and medical care provided within your clinical trial are free. Additionally, clinical trial participants may be compensated for their time and travel expenses. 

Is there anything important I should do before my clinical trial? 

Before participating in a clinical trial, potential clinical study volunteers are encouraged to discuss their trial participation plans with their physicians and medical care givers. Potential clinical trial volunteers should also be aware of as many details as possible surrounding their particular clinical trial. A few suggested questions to ask the research professionals conducting your particular clinical study are:

How long will my particular clinical trial last?

Where will my clinical trial be conducted?

What treatment is being tested and how will it be used?

How will my safety be monitored?

What are the possible benefits and risk of participation in a clinical trial?

It is also important to note that clinical trial volunteers are able to withdraw from their clinical trial participation at any time and for any reason. That being said, there are potential risks associated with clinical trial participation. For example, as a volunteer, you might experience unpleasant, serious or even life-threatening side effects to experimental treatment. There are also a host of possible benefits associated with clinical trials. For instance, volunteers may have access to effective medical treatments or therapies before they become available to the general population; they may also benefit from medical care that they may not have otherwise received had they not participated in their clinical trial; and they may play a more active role in their own healthcare. Finally, and possibly most importantly, Velocity Clinical Research volunteers possess the unique opportunity to contribute to advancements in medicine and treatment. Consequently, these clinical study volunteers play an integral part in improving lives, possibly saving lives and making the world a better place – a world filled with hope and a wide array of wonderful medical possibilities. 

Regarding privacy, as a clinical trial volunteer, your consent is needed before access to your personal information is available to your clinical trial investigator and research team. Clinical trial results may also be made available to government agencies, within scientific meetings and within medical journals.

What happens after a clinical trial?

After a study phase has been completed, the Velocity Clinical Research professionals review the data collected to determine the efficacy and safety of the treatment. Depending upon those results, the study will either continue on to the next phase of the clinical trial or the clinical trial will be discontinued.

What should I know about Velocity Clinical Research?

The longevity of Velocity Clinical Research is a testament to its operational excellence and proven, consistent reliable results. Founded in 2017, the focus of Velocity Clinical Research has been centered on clinical trials for over 250 years and includes over 5,000 successfully completed clinical studies. Velocity Clinical Research is composed of highly trained, dedicated study coordinators and accomplished physician investigators and research staff members whose subspecialties are numerous and diverse. These dedicated professionals treat their clinical volunteers with kindness and compassionate care. Velocity Clinical Research is conveniently located at 1410 S. Ridgewood Avenue in the lovely, vibrant town of Edgewater…and right next door to charming, beachside, historic New Smyrna Beach.