Clinical Research

At Stonesifer Clinical Research patients have the opportunity to participate in clinical research. These studies are usually sponsored by pharmaceutical companies looking at new medical treatments that have yet to be approved for endocrine or metabolic disorders or have been approved, but further studies are needed to better understand their effects.

Our studies are conducted by skilled and highly experienced Clinical Research Coordinators (CRC) under the direction of the Principle Investigator (PI), Dr. Stonesifer, according to the strict guidelines of the FDA (see below). When we first discuss the possibility of a clinical trial with our patients, you can be assured that we will present all the information regarding the study medication and expected procedures as completely as possible in everyday language, so the patient can make the best decision about whether or not to participate in the trial. All the information about the possible benefits as well as known side effects is discussed with the patient before the informed consent is signed. Ample time is given to answer any questions or discuss any concerns the patient may have, before they start the study.

Privacy issues are sometimes brought up by our patients. Just like your medical record, all information in the study record is strictly confidential. No names are ever reported to any pharmaceutical company or government agency.

During the study, patients are in frequent contact with the study team to ensure their safety and make sure the study protocol is being followed correctly. Some contacts may be in person, may be by phone, or electronically. Patients may be seen by Dr. Stonesifer, the sub PI (usually Marcia Miller, ARNP) or the CRC.

The most important part of any clinical trial is our patients’ well-being. The patient’s participation in the study may be terminated at any time by our staff if we feel it is not in the patient’s best interest to continue the study. If the patient feels he or she is in any way uncomfortable continuing the study, they may decide at any time to withdraw consent. Our study team is always available to provide patients with all the information they need to make these decisions.

Many of our patients have found participation in clinical trials quite rewarding. Not only do they often get advanced medical treatment not available to the general public (although some patients may be randomized to the standard treatment, see below), they feel good about their contribution to medical science. This may not help them at the present time, but may help others when the treatment becomes available. Sometimes these trials have “open label extensions” where all participants receive the study meds at no cost.

Financial considerations are also important when deciding if a patient should participate in clinical research. Not only do patients receive free medication, they also receive free medical visits, labs, EKG’s and other medical tests during the trial, even if they are randomized to the standard treatment group. Patients also receive a stipend for participation in the trial and reimbursement for travel expenses.

For more information about clinical research and clinical trials, please see below:

What is a clinical trial?

New medical treatments must be proven safe and useful before they can be offered to a large number of patients. These treatments are tested through clinical trials. A clinical trial is closely managed by physicians and study staff, an ethics board (also known as the Institutional Review Board), the company or organization that is paying for the trial and the Food & Drug Administration (FDA).

There are different kinds of clinical trials, including those that study:

  • Prevention options

  • New treatments or new ways to use current treatments

  • New screening and testing methods

  • Options for improving the quality of life for people who have serious medical issues

Why are clinical trials done?

Clinical trials are the safest and fastest ways to find treatments that work in people and new ways to improve health. Before a medication or treatment is used in the general public, it must be tested. The FDA requires 3 phases of clinical trials to show:

  1. Safety (phase 1)

  2. Usefulness (phase 2)

  3. Proof that the treatment is more useful than current treatments already available or has less side effects than current treatments (phase 3)

What happens in a clinical trial?

The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors, nurses and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

Deciding whether to be in a clinical trial? Some things to consider:

  • The treatment being tested may or may not help you. You may get better, you may see no change or you may get worse.

  • Your participation helps doctors learn more about the treatment being tested. This knowledge may help many patients in the future. It may not help all the patients who are in the trial.

  • Some trials offer experimental treatments that you cannot receive outside the trial. Other trials compare standard treatments that you may be able to receive without being in the trial.

  • In a randomized trial, you may receive the treatment being tested or you may receive the standard treatment. You will not know ahead of time which treatment you will receive.

Who can participate in a clinical trial?

Almost anyone can participate in a clinical trial. Some research studies seek participants who have the illnesses or conditions that will be studied. Other studies are looking for healthy participants. Clinical trials have standards outlining who can participate listed in the protocol.

Benefits from participating in a clinical trial include:

  1. Take an active role in one’s own healthcare

  2. Get access to new medical treatments before the general public

  3. Help others by contributing to medical research