Clinical Trails are Critical in Bringing New Drugs to Market
Written by Mike Haskew Updates by Melissa Watson
Research and development are critical components of progress in any field, and in medicine the introduction of new drugs is heavily dependent on the clinical trial.
Pharmaceutical companies are continually producing new medications, but the effectiveness of any one of them cannot be measured with any degree of accuracy until a group of actual patients gives it a try. Across the country, clinical research facilities solicit patients to participate in studies which take place prior to or soon after the approval of a new medication by the Food and Drug Administration. One of these facilities, ClinSearch, has been operating here in Chattanooga for nearly 2 decades.
Founded in 1990 by Dr. Richard Krause, a local gastroenterologist, ClinSearch has enrolled over 11,440 patients in more than 290 studies and developed relationships with almost 100 different pharmaceutical companies. ClinSearch has become such a major player in the clinical research field that it is a fixture in the top 10 percent in numbers of study participants.
Dr. Krause became involved with clinical research in 1992 for a couple of reasons. “I could see the writing on the wall,” he remembered. “Insurance companies were manipulating patients to go to particular doctors whether they wanted to go to them or not, and being involved with clinical trials gave me the opportunity to see patients that I would otherwise never see.”
Basically, a clinical trial is a research study initiated and funded by a pharmaceutical company and conducted by medical professionals who evaluate treatments or procedures. Quite simply, today’s clinical trials lead to tomorrow’s standard care.
Clnical research is conducted on four different levels at Clinsearch. A phase 1 study involves monitoring the progress of relatively healthy patients to make sure that a certain drug is safe. In Phase 2, a drug has been determined to be safe on a relatively small number of people, and the drug is administered to a larger number. Phase 3 includes the fine tuning of dosages and other criteria specific to the drug. Occasionally, a pharmaceutical company will commission a Phase 4 study, which may also be known as a post-marketing study, to compare its drug’s performance to that of a competitor after FDA approval.
“At the end of Phase 3, the data and results from clinical studies are presented to the FDA,” explained Dr. Krause, “and the FDA may take months or even years to give its approval. They do have a fast track they can put a drug on for approval if it is brand new or if there is a disease that no other drug can combat. Prilosec, one of the first proton pump inhibitors to be used for heartburn, was put on the fast track, for example.”
Clinsearch was involved in the study for Prilosec, and the process was typical. “We advertised for volunteers,” said Dr. Krause, “telling them that they would be trying a new drug and that they might get a sugar pill (placebo), or the real drug. We were looking for people over 18 who were experiencing heartburn on a regular basis. In the beginning, because we don’t know the proper dosage, there will usually be four arms in a study. These arms receive the low, middle, and high doses, and one of them gets the placebo. Because we are fine tuning in Phase 3, this type of study may only have two arms.”
Dr. Krause is selective with the studies in Phase 2 & 3. “I pick and choose the ones we get involved with,” he said, “based on whether or not I think the drug is safe or the study is important. Before we do a Phase 3, we get the chance to review the results of Phase 2, but Phase 2 is the most fun because it is on the cutting edge.”
To date, ClinSearch has conducted clinical trials on such ailments as Celiac Disease, Chronic Constipation, Migraines, Acne, IBS, and more.
According to Dr. Krause, recruiting patients is not a difficult thing to do. “I would bet that half our patients come by word of mouth from friends or relatives who have heard of us or participated in previous studies. The people of Chattanooga have been very willing to participate. Some of them may come through my office after talking to me or seeing us advertise,” said the native of Philadelphia who came to Chattanooga in 1997.
“I may suggest a study to the patient if they aren’t responding to current therapy, and we don’t take a patient off current medication if they are responding,” the doctor continued. “We don’t try to convince people to go into a study. We just expose them to the information. If someone has heartburn and they aren’t responding to treatment, they might be interested in a study. We give a lengthy explanation of the pros and cons to the patients and discuss the risks, which are the unknown and the potential side effects.”
Throughout the course of a clinical trial, it is clear that the health and welfare of the patient are the primary concerns. While it might appear to the layman that talking a drug is safest after FDA approval, it is actually safer during the trial. Each study participant is provided with a document called an informed consent form, which describes the risks, benefits and expectations of the study in detail. Because the patients are monitored closely, any adverse effects or developments are discovered early.
“I explain to patients that our research studies are really safer than taking a brand new drug which just came on the market,” commented Dr. Krause, who completed his internship and residency at Grady Hospital in Atlanta through Emory University, and his GI fellowship at Yale University. “We monitor patients much more closely than a private physician could. We don’t have to get approval from an insurance company to run an EKG or a blood test because the drug company is paying for it. The drug companies usually require monthly blood tests while the patient is in the study, and the reason for this is that most drug side effects occur in the liver or the kidneys. If these side effects occur in a patient, they will usually be detected through these tests before the patient even has any symptoms.”
Some drugs, says the doctor, have actually received FDA approval after studies of groups of as many as 5,000 patients. However, if the frequency of a side affect is one in 10,000, theoretically it may not be discovered until the drug is mass marketed and hundreds of thousands of patients are taking it.
“In situations like that, the FDA is blamed for not being more careful,” noted Dr. Krause, “but it would be cost prohibitive to run a study on such a large scale. If a patient takes and new drug outside a study and is developing liver failure, they may not know it, and they could even die. But, we monitor our patients much more carefully. I call them “guinea persons”, and I always tell them that if they do not get better on the medication we will take them off of it, usually after about a month, or sometimes even a couple of weeks.”
The direct benefits to the patient in include:
- A chance to try a new medication if you are not responding to current treatment
- Many studies include one year of medication at no cost
- Compensation for time and travel
- Aiding in the development of new treatment options
Our clinical trials are usually a win/win for everyone.