Frequently Asked Questions

clinical research volunteer guildlines

The Clinical Research Center is a division of Center for Cough. Dr. Mandel Sher is the founder of Center for Cough and the Principal Investigator on all clinical trials conducted here. This page introduces you to clinical research and why you may consider volunteering for a clinical trial to make a difference for yourself and generations to come Dr. Mandel Sher and our team appreciate your interest in clinical research and consideration of participation.

What are the potential benefits of me participating in clinical research?

You do not need to be an established patient at Center for Cough to qualify for a clinical trial. There are two potential benefits of participating in clinical research: a direct benefit to you and a benefit to others who are now or sometime in the future suffering from the same medical condition. By participating in a clinical trial, you will have access to a drug or device that is not yet available to the public. The drug or device that is being studied may have a direct health benefit to you, your Cough, and your overall outcome. You will also have access to the world-class Cough care and treatment of Dr. Mandel Sher and Center for Cough team.

Other benefits include:

  • Free office visits, laboratory and other procedures related to the study
  • Health insurance is not required
  • Possible financial compensation for time, travel and participation
  • Free study drug
  • Appointment scheduling that accommodates your schedule

What is clinical research also known as clinical trials or clinical studies?

Clinical trials are research studies that investigate new treatments or devices. The Food and Drug Administration (FDA) reviews and analyzes information from clinical trials to determine whether a drug or device should be approved and made available to the public. Medications that are available now have resulted from successful clinical research and FDA approval.

Clinical trials give patients access to cutting-edge treatments before they become available to the public. In addition to acting proactively to benefit yourself now, by volunteering for a clinical trial you will be helping others by advancing tomorrow’s medicines today.

Why is clinical research important?

Clinical studies offer patients a treatment option that may not otherwise be available or a better treatment option. Clinical research adds to the body of knowledge in the medical community and advances treatment. In addition to benefiting volunteers today, successful clinical trials may benefit many people tomorrow.

How are doctors selected to lead clinical trials?

Not all doctors meet the standards to lead clinical trials. Doctors are selected based on rigorous review of their practice’s quality and ability to execute a clinical study according to the clinical trial’s protocol. Because patients rely on their doctors to direct their treatment, and because only few doctors offer clinical research as a treatment option, it behooves patients to conduct an internet search for clinical trials that may help their medical condition.

As a clinical research volunteer, you will enjoy the same outstanding patient experience as Center for Cough patients. This includes your care in a private and professional medical setting by an experienced and caring team who appreciate the contribution you are making to improved treatment options. Dr. Mandel Sher and the clinical research team become familiar with each and every clinical trials volunteer and are available to address your care and questions.

Are clinical trials safe?    

Your safety is our first and foremost concern.  Safety begins with you choosing a clinical research site that has demonstrated a track record of successful research, and you understanding the potential risks and rewards of the clinical trial for your condition.  Our clinical research is compliant with FDA guidelines including an informed consent process and monitoring by a review board of professionals who are not directly connected with the research.

Your confidence and comfort matters. Please call (727) 393-8067 to contact our Clinical Research Nurse Coordinator, who will happily discuss the clinical research process as well as the specific clinical trial you are considering.

What is a typical clinical research experience?  

Once you contact Clinical Research Center and let us know of your interest in volunteering for a clinical trial, we will work with you to find an appropriate study. We will have an initial telephone conversation to discuss the study opportunity. We will also screen you to ensure that you meet the basic study requirements and that the potential benefits of the study drug are in your best interest.

Each volunteer will be advised of the potential benefits and risks as well as rights of participation. An informed consent form will be signed and then the enrollment process is complete. Once you are enrolled in a study, you will be randomly assigned to a treatment course that is not even know by your doctor or research nurse coordinator. The protocol for the study is similar to following a recipe. There are defined steps and milestones for study visits and what will be done at each visit.

May I participate in more than one Clinical Trial?

Yes, but only one at a time, please. Many of our clinical trial participants have such a positive experience that they enroll in another study when their current trial is complete.

When does a study drug become available for FDA approval?

There are 3 phases of clinical trials:

  • Phase I: First step after the new treatment has shown promise in the laboratory. Typically involves healthy volunteers. Phase I trial generally assesses the study drug’s safety.
  • Phase II: Involves a larger group of participants than Phase I. This phase generally evaluates whether the study drug has a positive effect on the condition.
  • Phase III: Involves an even larger group of participants than Phase II. Phase III trial compares the new treatment with the currently approved standard treatment. If a Phase III trial shows that the new treatment is safe and more effective than current standard treatments, an application for FDA approval may be submitted.

Will the study cost me anything?

No. Access to Dr. Mandel Sher’s expertise and medical services are at no cost to you. Health insurance is not required. Clinical research volunteers receive doctor visits, lab tests, study drugs and other related services at no cost. In addition, volunteers are often financially compensated for their time and travel.

How can I learn about clinical trials for my cough and find out if I qualify?

Dr. Mandel Sher is one of the nation’s leading clinical research investigators. As such, Clinical Research Center division of Center for Cough is frequently offering new clinical trials. People suffering with Cough may participate in one clinical trial at a time, but may enroll in another study once they have completed another. In fact, many of our Cough patients have had such positive experiences as a clinical research participant that they enroll in clinical trials over and over again.

So, if you don’t qualify for one study, try again! Each clinical trial has specific participation requirements. We will work with you to find a clinical research study that is right for you.  And if you have a family member, friend or colleague who may benefit from one of Clinical Research Center’s clinical trials, please encourage them to let us know their interest. We welcome their participation.

Please continue to check our current clinical trials page or Center for Cough’s facebook page to find out about our latest cough clinical trials.  We also invite you to contact our Center for Cough’s Clinical Research Nurse Coordinator, at (727) 393-8067 to discuss current and upcoming clinical trials. Sheila maintains a list of people interested in clinical research and will be happy to reach out to you when an appropriate study becomes available.