FAQ's
  What if I change my mind about participating after I am enrolled in the trial?

We encourage you throughout the study and will have close contact with you to continue to motivate you and help you to complete the study. Nevertheless, you are free to discontinue participation at any time. It will not affect the care you receive from your physicians or staff at Huey and Weprin Ob/Gyn. Finishing a study can be very rewarding. Your contribution of time to complete the study may not only help you and your condition, but it paves the way for members of the general population to have the drug or procedure following FDA approval.. Your contribution and commitment is invaluable in improving the standards of care for all women.

  How is my safety ensured?

The ethical and legal codes that govern medical practice also apply to clinical trials. Clinical research is highly regulated by the FDA and other governmental agencies and it is closely monitored by the sponsoring company to ensure your safety and privacy throughout the trial. Data about you does not include your name or personal information, but merely a study number to protect your privacy. If anytime during the trial your physician feels it is not in your best interest to continue to participate due to side effects or other problems, you will be terminated from the trial for your safety and comfort. However, the adverse effects are also reported to the study sponsors to help eliminate possible side effects or adverse events for all the study participants.

  Who will take care of me while I am in a trial?

The clinical research team includes Dr. Stuart Weprin and Dr. James Huey and a clinical research coordinator. The team will be monitoring you closely throughout the trial to ensure your safety and also monitoring any adverse symptoms or improvements in your condition.

  Are the required medications, appointments, labs, and procedures free?

Yes, unless a medication or treatment is already approved by the FDA as a standard of care, you will be given free investigational medication, clinical exams, and any testing procedures required by the study. The sponsoring company pays for your care while you are participating in the study. That will also reimburse you for your time and travel to your visits. You will be given information during your first screening visit so you will know how many visits will be required, what tests are required, and how much you will be compensated at each study visit. Post FDA trials for long term safety and efficacy involving surgical procedures are frequently covered as a standard of care by your insurance company, however you are still compensated for your commitment of time and travel to you study visits.

  What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the participants will receive a placebo. Neither you nor your physician will know if you are receiving the study drug or the placebo until the study is completed. This is to prevent any bias in the study. However, if there is a medical or urgent reason that this information is necessary, it will be provided by the sponsor to you and your doctor.

  What is a "Protocol"?

A protocol describes the ideal study candidate that meets the inclusion-exclusion criteria. It also describes the schedule of visits, tests, procedures, medications, and dosages, as well as 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 determine the safety and effectiveness of their treatment.

  Who can participate?

All clinical trials have guidelines listed in the protocol about who can participate. The factors that allow someone to participate in clinical trial are called “inclusion criteria” and those that disallow are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, the length of the study, etc. While in a clinical study, participants following a protocol are seen regularly by the research staff to monitor their health and to determined the safety and effectiveness of their treatment. Before joining a clinical test, a participant must qualify for inclusion based on the inclusion criteria in the protocol. Some research studies seek participants with illnesses or conditions that are to be studied in the clinical trial while others need healthy participants. Inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria is used to identify appropriate participants that will be able to participate safely, as well as answer the questions that researchers plan to study with the protocol used during the trial.

  What is a clinical trial?

A clinical trial is a research study in human volunteers to answer specific health question, test a new drug formulation, or a new procedure for a variety of medical conditions. These studies are sponsored by leading pharmaceutical and medical device companies and are carefully monitored by the FDA and other regulatory agencies to ensure the patient's safety and privacy throughout the trial. Carefully conducted clinical trials are the fastest way to find treatments that work in people wand ways to improve health. They are also the stepping stone for new treatments, medications and surgical techniques that will be submitted to the FDA for approval. All clinical trials start with testing in the lab and/or in animals to ensure safety prior to trialing the treatment in a human volunteer population.

  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 treatment before they are widely available, and help others by contributing to medical research. For most studies, the participant is given access to an investigational drug or treatment not yet available to the general population. The sponsoring company provides you with free medical care with Drs. Huey and Weprin throughout the length of the study. Procedures, exams, lab work, pelvic exams, paps, ultrasounds and mammography would be provided at no charged to you if it is required for the protocol. In addition, you are given free study medication as well as monetary compensation for your time, travel, and commitment to the trial.
 
Before joining a clinical trial, a participant must qualify for inclusion based on the inclusion criteria in the protocol. Some research studies seek participants with illnesses or conditions that are to be studied in the clinical trial, while others need healthy participants. Inclusion and Exclusion criteria are not used to reject people personally. Instead, the criteria is used to identify appropriate participants that will be able to participate safely, as well as answer the questions that the researchers plan to study with the protocol use during the trial.
  What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. Some trials involve new medications being tested to gain FDA approval, while others are drugs or treatments that are currently available, but might be studied for a different application or condition. There are also medical device trials that involve new procedures and surgical techniques being tested prior to approval by the FDA. And some products are already FDA approved- but the study is designed to show long-term safety and efficacy for use of the device or procedure.