For the last three years, the CNMRI Neurology firm has asked some of its patients to volunteer for clinical trials that help ascertain the effectiveness of new and experimental drugs.

For the last three years, the CNMRI Neurology firm has asked some of its patients to volunteer for clinical trials that help ascertain the effectiveness of new and experimental drugs.

CNMRI engages in research that helps to fine tune new drugs – approved by the FDA – that will combat such illnesses as multiple sclerosis, epilepsy and other diseases of the brain. The practice also researches some experimental drugs that have not yet been approved by the federal Food and Drug Administration.

As CNMRI owner Dr. Robert Varipapa puts it, this type of medical research is no longer limited to the realm of academia.

"We can offer them the most cutting edge treatment in many instances,” said Varipapa, a University of Maryland School Of Medicine graduate. “It was available, in the past, only at large, academic medical centers. Now we can provide it, right here in Dover."

And, to be candid, the research provides supplemental income to the practice, said CNMRI clinical research coordinator Mike Paradise, who got his start in clinical research at Johns Hopkins University.

“It’s difficult to run a medical practice today – especially a specialty practice,” Paradise said. “So, what special practices or medical practices look for sometimes is a different revenue stream. Pharmaceutical research can provide that.”

The benefit for patients is that they get free access to expensive drugs that ordinarily would not even be available to them in greater Dover, Paradise said.

“For instance, one of the things we were able to offer this past year, was a study where you could get an oral MS drug,” he said. “Up until this point, all the drugs had been inject-able. The FDA approved one in September. Although you could get it on the market, it was very expensive.”

There are different phases in research, Paradise said. Phase 1 pertains to animal research, phase 2 is when small groups of people take experimental drugs, phase 3 expands to a larger group of people and phase 4 pertains to post-marketing studies on drugs already approved by the FDA. CNMRI engages mostly in phase 3 and phase 4 studies, he said.

“Any research study has an element of risk involved, but you can significantly reduce that risk in a phase 3 study,” he said.

CNMRI is conducting research on drugs for epilepsy, Parkinson’s and multiple sclerosis, Paradise said. In the future, the clinic is looking to conduct studies on migraines.

Throughout the research, the subjects always remain patients first, CNMRI officials said. It is important to make sure that trials cause no harm to patients.
The FDA asks researchers to be as unbiased as possible in dealing with patients who want to be involved in clinical trials, Paradise said. That starts with the Informed Consent Form, which includes the reason for the study, what's required of the subject, what risks and benefits are likely to occur and the timelines.

As with any medication or procedure, Varipapa educates patients about the advantages and disadvantages of clinical trials and helps them make a decision as to which way to go, he said.

“Sometimes it is a no-brainer as the patient may get the medication and medical follow up at no cost by being in the study, versus getting the same medication through normal channels,” he said. “Some of these medications cost more than $50,000 a year and even the co-pay can be onerous. So, many times, it is a big plus for the patient to be in the study.”

CNMRI is working with such national and international pharmaceutical companies as Novartis, Schwarz, Biogen Idec, Teva Pharmaceuticals, Pfizer, Merck & Co. and Lundbeck.

“When you hear about a pharmaceutical company spending money on research and development, they’re actually spending money on research, development and failure,” Paradise said. “That’s really what it takes, sometimes. Pasteur said, ‘Discovery favors the prepared mind.’”