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FAQ

Frequently Asked Questions About Clinical Trials

What is a Clinical Trial? How do I join a Clinical Trial?

Choosing to participate in clinical trials is a big decision, so we want to make sure you’re completely informed. Find out what a clinical trial is and what you can expect when volunteering to participate by browsing the questions below.

What is a clinical trial?

Clinical research trials are supervised research studies of medical procedures or medications to evaluate their safety and effectiveness. Each clinical study is designed to answer specific scientific questions and to find new and better ways to help patients. For any given disease or condition, a clinical trial may:

• Establish the first effective treatment
• Establish a more effective treatment
• Establish a better tolerated treatment
• Find a new use for a currently available treatment

How are new drugs approved?

Before a medication can be prescribed, it must undergo an extensive  testing and approval process. First, the investigational medication goes through rigorous preclinical testing. If it is permitted by regulatory agencies for the next phase of drug development, the investigational medication is then tested for safety in humans through clinical research studies. If endorsed by regulatory agencies after that, the investigational medication is further tested for both safety and effectiveness in patients with the disease or disorder it is intended to  treat. The sponsor then submits a report (New Drug Application) to the appropriate regulatory authority, who either approves it, rejects it, or  requires more testing.

What if I change my mind?

That’s no problem. Our medical trials are voluntary, so if you have a  change of heart after you've applied, at the screening session or even  during the clinical trial you are free to withdraw your consent. If you’ve already started the clinical trial, our doctors may want you to  come back for a visit, just to check that the drug is out of your  system.

How are the rights and welfare of a study participant protected?

Clinical research studies are conducted by qualified medical staff and physicians. Additionally, various  worldwide agencies have regulations to protect clinical research participants and standards for how studies are conducted. For example, an independent review board / ethics council (IRB / IEC) reviews each study protocol and associated materials. This review is conducted to make sure the study is scientifically and ethically sound. The IRB / IEC oversees the processes that the clinic uses for informing you about  clinical research studies, including why the study is being done, what will happen during the study, risks involved and previous study results that may impact an individual’s willingness to participate.

Will my information be kept confidential?

Your privacy will be respected by Medical Research Group of Central  Florida staff and no information will be given out about your  participation and/or your medical information unless required by law.  For example, the Sponsor and its representatives, applicable regulatory  agencies such as the US Food and Drug Administration, and the authorized  independent ethics board may inspect your clinical research study  medical records, which may include your name, address and other personal  information that identifies you. If necessary, some or all of your  records may be copied during these inspections. The results of the clinical research study may be presented at meetings  or in publications. However, you will not be personally identified in  any presentations or publications.

Where can I find independent information?

There are a number of online resources you can use. We have included a list of a few to get you started below:

ClinicalTrials.gov
ClinicalTrials.gov is a registry of federally and privately supported  clinical trials conducted in the United States and around the world.

CenterWatch.com
CenterWatch.com provides an extensive list of clinical trials being  conducted internationally. The web site also lists promising therapies  newly approved by the FDA.

CISCRP.org
The Center for Information and Study on Clinical Research Participation  (CISCRP) is a nonprofit organization dedicated to educating and  informing the public, patients, medical/research communities, the media,  and policy makers about clinical research participation and the role  that each party plays in the process.

Will I be paid for my participation?

Yes. You'll be paid for your time and  participation during the study after each completed qualified visit.   The payment you receive varies from study to study, depending on its  length and type.

What are the risks and benefits of taking part of a clinical trial?

Potential risks and benefits vary from study to study.  However, if you  are interested in participating in a specific study, potential risks and  benefits will be explained to you before you give your consent to  participate.  You will also be able to ask questions of our medically  trained staff if you have any concerns that are not addressed.

By taking part in a clinical trial, you'll play a role in helping  develop the medicines of the future. This could include breakthrough  treatments for Diabetes, Depression and Alzheimer’s, potentially  transforming the lives of millions of people across the world.

By taking place in a clinical trial, you receive study related  assessments by a Board Certified Medical Doctor, study-related  medication and labs all at no cost to you. You will also receive  compensation for your time and travel while in the study.

How do I take part?

It’s easy to volunteer. You can either click Apply to be a volunteer or call our recruitment team.

1. First you’ll speak to a member of our clinical team who will  determine whether you qualify for a current clinical trial. This is  based on the information you give about yourself and your medical  history.

2. If you’re eligible you’ll then be invited to a screening session at  our clinic with our qualified study coordinators and doctors. This will  include blood and urine samples, having your blood pressure measured and  having a physical examination.

3. Once your screening results are in, we’ll contact you to let you know  whether or not you are eligible to take part in the clinical trial you  screened for.

What if I fail at the screening stage?

There are all sorts of reasons why  applicants don’t make it past the screening stage. Whatever the reason  there’s no need to worry as we’re here to offer support and answer any  questions you may have. You can ask to see if it may be possible for you  to reapply as a volunteer in the future or even on another study we are  currently recruiting for.

Why am I screened for each clinical study?

Screening is the process we use on clinical trials to see who can take part.

Clinical trials at this stage use relatively small numbers of people and  therefore we need to make sure the people involved in the trial are  eligible as they will provide data that can be compared and studied.

How long will my screening last?

Screening requirements vary with each  study.  You will be advised about the requirements for a particular  study when you call.  On average, a screening appointment lasts 2-4  hours.

What is a screening visit?

It’s reassuring to know what you can expect from your visit. During your  time with us you’ll meet our staff which includes doctors and study  coordinators who will take you through the following screening process:

• We’ll take a copy of your photo ID and a picture for our database when you arrive.
• Our medical team will explain the study and answer any questions you may have.
• If you agree to take part, you’ll be asked to sign a consent form before any tests are done.
• We’ll take a detailed medical and social history.
• We’ll take blood and urine samples.
• We’ll measure your blood pressure and pulse and record a heart trace.
• Once we have your results, we'll be in touch and inform you of the next steps.

Can I take part if I'm not on medication?

This varies for each medical trial depending on what medication you are on and the trial design.

Each clinical trial has different requirements for volunteers. Most  healthy volunteer trials require just that – healthy volunteers – and  therefore if you are taking long-term medication, you may not be  suitable. Often if you are on short-term treatment, for example, a week  of antibiotics for a throat infection, you would be able to take part  once you have finished the course of medicine and the condition it was  treating has cleared up.

However, research is also conducted in patient groups who may need to  take medication to manage their condition. In this case it will depend  on the trial requirements, but the trial will often be designed to allow  patients to still take their normal medicines.

As this changes from trial to trial, please contact our recruitment team  and they can discuss what clinical trials will work for you.

What is involved in participating in a study?

Each study has specific procedures that  you will complete during each visit, each specific to the study  protocol. Procedures include but not limited to blood draws, physical  exams, vital sign checks and patient assessments.

Who can participate in a study?

The studies conducted at our clinics generally require that you are at  least 18 years of age. Medical eligibility requirements vary with each  clinical study. Phase II/III clinical studies require that you meet  qualifying criteria determined by the study protocol - this can include  restrictions on medications, recreational drug use and alcohol.

Where can I find out about upcoming clinical trials?

You'll find more information on all our clinical trials by clicking on  browse current studies. As well as the clinical trial names, dates and  payment, there are details about what the study involves and what type  of volunteers we’re looking for. Or if you prefer, call us at:

Orange City – (386)775-7627

Sanford – (407) 330-2262

You can also find study information on Craigslist and Facebook.

What are my responsibilities as a volunteer?

Depending on the type of study you’re  volunteering for, there are certain conditions we may ask you to meet to  ensure accurate trial results. These could include restrictions on  exercise, smoking, medications and alcohol.  We’ll give you full details  before you apply to take part in a study so you’ll always know what’s  expected.

Can I take part in more than one clinical trial at the same time?

No. For each drug trial to provide the  level of information needed to understand how a new medicine works, volunteers can only take part in one study at a time with 1-3 months in  between the end of one trial and the start of another.

What if I change my mind?

That's no problem. Our medical trials are voluntary, so if you have a  change of heart after you've applied, at the screening session or even  during the clinical trial you are free to withdraw your consent. If  you’ve already started the clinical trial our doctors may want you to  come back for a visit, just to check that the drug is out of your  system.

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2725 Rebecca Ln, Ste 105
Orange City, FL 32763
Tel: (386) 775-7627
Fax: (386) 775-0570
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