Steven Sussman, MD, FACOG

Medicine in the United States has experienced dramatic diagnostic, surgical and therapeutic advances over the past four decades, which has enabled healthcare providers to treat and cure illnesses and to extend one’s life expectancy in ways that could only have been dreamed about just a half century ago.  Of the many changes responsible for these extraordinary improvements, none are more important than the advances made in the pharmaceutical field – with the discovery of new medications to treat an entire world of diseases.

Pharmaceutical medications are developed in laboratories of clinical research. However, without patients to volunteer to use these medications, few of these advances would be possible. As such, we all benefit from clinical research trials.  The CICRP (Center for Information in Study on Clinical Research Participation) refers to clinical research volunteers as “medical heroes”. I like to think of them as medical “champions” – champions of their own health and well being, champions of their community and their health care providers, and champions of medical science as a whole.
Simply put, participating in a clinical research trial allows one to receive a therapeutic medication which is presumably effective in promoting one’s own health and well being, while at the same time proving the safety and effectiveness of the drug so it can ultimately be used to treat a large population.

Phases Of Clinical Trials
To participate in clinical research, it is important to understand that there are four basic phases in involved in the development of a new drug:

Phase I studies are the initial studies, when only a few volunteers are given the drug to determine if it is safe; meaning that there are no obvious adverse side effects.  Because of the small number of patients involved, it is rare that one has the opportunity to be involved in a Phase I study.

The drug then moves into a Phase II trial.  This is where several hundred patients are asked to volunteer to take the drug, and both safety and effectiveness data are collected. Studies in Phase II typically last a year or more.

If a drug is determined to be safe, and shows evidence of being significantly effective, it then moves to a Phase III trial.  In this phase up to several thousand people may be enrolled, allowing for accurate data and information which can clearly define whether or not the drug will work for a specific disease in a large population.  This information can then be presented to the Food and Drug Administration for approval to be marketed.  This Phase III process can last one to three years.
After a drug is approved for marketing additional uses may be investigated, leading to Phase IV trials, or “after market” trials. This is how new doses and new indications for a drug can be discovered.

Becoming Involved
When enrolling in a clinical trial, the first step will be the informed consent process, possibly the most important step in the trial. Be absolutely certain that you understand what is involved in the trial, what is involved in the protocol, and what is known about the drug. Remember, if you don’t understand the information, it is NOT “informed” consent.  The investigator will be present to answer any and all questions.

It is also extremely important to follow the  protocol and take the medicine as instructed.  Pharmaceutical scientists spend many hours developing the protocol in order to maximize the safety of the participants.  And by following the protocol, the data can be accurately collected so the safety and effectiveness of the drug can be ultimately proven.

One of the nicest benefits to participation in a clinical trial is that the medication, office visits, and associated testing are generally provided free of charge. And because it is understood that a patient will be asked to take time out of his or her busy lifestyle and schedule, generally he or she will be offered a stipend to participate in the trial.  However, the offer of payment should never be the main reason for entering a trial.

At Lawrence Ob-Gyn, we are proudly collaborating with multiple pharmaceutical companies in the development of their new drugs. Examples of our clinical trials involve contraception and pregnancy prevention, adolescent hormones and their effect on bone density, medication for the treatment of iron deficiency anemia, and we are working toward the study of developments regarding the Human Papilloma Virus and precancerous changes on the uterine cervix. Our clinical research program allows our doctors, midwives and nurse practitioners to remain on the cutting edge of developments in the field of gynecology and obstetrics, and enables our patients (and others in the community) to participate in advancing medical science.   In this way, we all become champions!