Volunteering for a Clinical Research Study at Hanover Medical Specialists
Karen Kass, R.N.
Clinical Research Coordinator

The Clinical Research Department of Hanover Medical Specialists (HMS) has been in operation for about a decade and offers an opportunity for people in the Wilmington area to volunteer for various clinical trials. There are many advantages for the volunteers who participate in clinical research not the least of which is the sense of well being in knowing that they have helped medical science in a way that affects many other people’s lives. Another important advantage is that the volunteer may actually find some relief for a condition that has not yet been relieved by other medical care.

When participating in a clinical trial the participant’s health, safety, welfare and privacy are the utmost concern of the physicians and research staff at Hanover Medical Specialists. To protect participants (subjects) from any unnecessary risks all clinical trial studies are overseen by an IRB (Institutional Review Board) comprised of physicians (not involved in the study in any way), lawyers, nurses, clergy, and lay persons from varied other walks of life. The IRB meets regularly and foremost among other functions the board determines that the clinical research studies remain safe, legal and ethical.

Hanover Medical Specialists consists of physicians specializing in Cardiology, Endocrinology, Gastroenterology, and Hematology / Oncology. Through clinical trials they are able to provide medical care and attention to individuals who might not otherwise be able to receive medical care. Clinical Research studies also provide new and investigational drugs to participants that they might not be able to obtain except through the research study. The latest equipment and facilities for radiographic and laboratory examinations are available to them in the trial if required.

The HMS physicians, who are involved in clinical research, are called Investigators. Dedicated research staff is composed of Clinical Research Coordinators (CRC), who are registered nurses trained and updated in clinical research. Their work is constantly reviewed by monitors, who are pharmaceutical representatives, to ensure the protocol is being followed and that subjects are properly informed and have given written consent. Monitoring also validates Good Clinical Practices and that all FDA regulations are being followed to ensure the integrity of the study for the sponsor and protect the participants.

Accuracy of data is of primary importance. Much care and attention is given to the gathering of information. Procedures performed may include electrocardiograms, phlebotomy, blood pressure checks, physical exams, endoscopies as well as other tests as required by the study. The results of these tests are made available to the participants, and may be shared, at their request, with their Primary Care Physicians. The procedures are performed at no cost to the subject. In addition, subjects are often given a stipend for their time and travel at the end of their participation.

If the clinical research study includes drug therapy, the subject may receive study medication or a placebo. Often, one group receives placebo, called a sugar pill, or an inactive substance. The studies are often ‘blinded’; neither the subject nor the research staff knows whether the subject is receiving placebo or study medication. This is done to insure that the study medication is truly effective.

While a subject is in a clinical trial they are monitored very closely and given special attention. Explanations are given by the research staff for procedures and other evaluations that are required by the study. The CRC record all the subjects’ complaints, no matter how minor they may seem. If the subject misses an appointment the CRC will call and making every effort to have the subject return to the office in order to keep them on track with their study schedule, allowing them to continue to receive their study treatment. It is important that the subject understands what is being done during their participation so questions subjects may have regarding their participation are readily answered. As a result the research subject is given “VIP” treatment.

Confidentiality and privacy is of great importance. Subjects are identified by their initials and assigned a number. The research data and medical records are made available to the sponsor’s monitor. They will review the signed informed consent. The FDA will be given information collected from the study, and information may be published. Every effort is made to keep the subject’s identity confidential.

A subject may withdraw from the study at any time. However, it is important they return for one final visit in order for the investigator to examine the subject and to complete a final evaluation and make certain that subject is medically stable. The subject must return all medication given to them so it can be returned to the pharmaceutical company.

When the subject’s participation is complete, the study medication is not always available to the participant. It may not be available for a couple years. On occasion, under certain circumstances, it may be available to an individual with special permission, if they are responding well and it is soon to be marketed or is on the market for a different indication.

Clinical Research has always been a valuable part of medicine. Having qualified, willing, and compliant participants as subjects are important. Without these volunteers, it would not be possible to perform research and find new ways to prevent and treat diseases and illnesses that afflict so many of us. By volunteering, one not only helps themselves, but many others to live a healthier life.

For more information regarding studies currently underway at Hanover Medical Specialists, please call (910) 763-0131.