Photos By Hillary Ehlen
This content is sponsored by Lillestol Research
It all started with a letter. In 1991, Dr. Michael Lillestol received a letter at home. The letter was from a pharmaceutical company inviting him to participate as a physician in an upcoming osteoporosis trial. Knowing that he was busy, he threw it in the garbage. As fate would have it, however, his wife, Mary, an RN, was interested and picked it back up. That letter started them on an unexpected journey that would create a long-lasting family business and a clinic dedicated to the advancement of medicine. That letter was the first step towards Lillestol Research.
What is Lillestol Research?
In order for a medication to receive approval from the Federal Drug Administration (FDA), it must undergo a sequence of trials. Those trials will provide information to ensure that the new medication is both safe and effective at treating the indication it is intended to treat. Lillestol Research works with both large and small pharmaceutical companies to conduct trials on these upcoming medications and treatments. These trials will involve various levels of checking to see how well they respond to test subjects as well as other processes that will come up, this will include manufacturing the medication if it gets approved. If this does happen the pharmaceutical industry will find the best ways to get this ready for distribution, including using top-of-the-range manufacturing machinery, which this post can discuss further.
“We determine what trials are a good fit for us as a site and what kind of patient demographic the pharmaceutical companies are looking for,” said Jamie Brown, PA-C, Director of Operations. “If the trial fits our site, we’ll move forward and let our patients know that it’s upcoming.” Andrea Lillestol, Director of Marketing, added that they have a large patient database with over 18,000 individuals who have expressed interest in participating in clinical trials with them at some point.
How a trial works
In order to receive FDA approval, a new medication will go through up to four phases of clinical trials. Phase 1 is the first clinical trial phase conducted in humans. Phase 1 will be conducted in what are commonly referred to as “healthy patients” and generally involve longer/overnight stays. The Phase 1 trial data will hopefully help to advance the new medication to the next phase of research. Lillestol currently does not participate in Phase 1 trials.
Lillestol trials are generally conducted in Phase 2 and Phase 3 with a few aftermarket trials (Phase 4) as well. Phase 2/3 trials look at safety but are truly aimed at testing the effectiveness of the new medication. The hope is that the new medication would be as effective, if not more effective, than what is currently on the market. At this phase of research, the medications are being evaluated in patients with ongoing health conditions and who are likely already taking medication.
“I would say probably half of the patients we evaluate to participate in a trial will actually move on to screen for a study,” said Brown. “From there, about half of the patients who screen for a study will enroll into the trial to take the trial product. Depending on the study, we may start out with a lot of interested and potential participants, however, that pool gets narrowed down as we review medical history and the patient’s current medications. There is a lot of criteria that we review that could exclude someone from participating and the reason for that is patient safety.”
What a trial looks like
The trial participation experience at Lillestol will be top of the line, especially considering their brand new office space located within the MedPark Medical Center in south Fargo. A priority for Lillestol is to provide their patients an atmosphere that is welcoming, comfortable and professional. Kim Peterson, Chief Operating Officer, said that the trial participation schedule and time commitment for their patients will involve no overnight or weekend stays and is very much like visiting a doctor’s clinic on an ongoing basis. The clinic visits are generally short and participants are also paid for their time.
Brown took us through the Lillestol process of participating in a clinical trial.
1. You may express interest in a trial via their company website, a phone call, email and/or responding to an advertisement you’ve heard or seen. You will be directed to a Recruitment Coordinator to discuss the trial(s) that you have interest in. You may be invited to the clinic for a quick, no obligation Health Screen.
2. At a Health Screen, the Coordinator will briefly go through your medical history and may also check cholesterol, blood sugar levels or other health indicators to determine which trial(s) you may be a fit for. If it is determined that you would not fit in any of their current studies, you will be invited to be entered in a database and notified of upcoming trials that you may be eligible for.
3. If you are interested and determined to be a potential fit for a trial, you would then schedule a Screening Visit. To begin the Screening Visit, you would read and review an informed consent form, which will go through all the information about the trial in laymen terms.
4. Upon completing the Screening Visit and entry criteria, you would be officially enrolled or “randomized” to the trial and begin receiving your assigned trial medication or comparator.
5. The trial schedule and number of clinic visits will be dependent on which trial you end up participating in. You’ll return to the clinic for ongoing visits throughout your participation and for the length of the trial. The length of trial participation varies depending on the study.
For Future Generations
While there are many reasons to participate in a trial, one of the most important is that trial participants play an integral part in advancing medicine for future generations. As your children or grandchildren age, they may experience the same health conditions you have. Your participation could affect what treatments would be available for those health conditions in the future.
Throughout their years of conducting studies, Lillestol has seen a lot of success with new medications and the treatment of conditions like diabetes, osteoporosis and fibromyalgia. “Some of the patients on our trials have never experienced anything that works well to treat their condition. They are very excited when a trial medication works for them,” said Peterson. “Trials are the only way that new medications get to market for the general public.”
Lillestol is always looking for more participants in their current and upcoming studies. They usually have around 40 trials going on at one time in various indications related to internal medicine. For a full list of trials, call their office at 701-232-7705 or go to lillestolresearch.com.
Their new office
Lillestol Research recently moved into the MedPark Medical Center located at 4450 31st Ave. S., Ste. 101, Fargo. Their office was designed specifically to make patients comfortable during their clinic visits.
List of current trials
Asthma (4 years of age and older)
C. diff Vaccine
Irritable Bowel Syndrome (IBS)
Type 1 diabetes
Type 2 diabetes
Interested in a health screening? Get involved
To learn more about Lillestol Research and how to get qualified to participate in their trials, give their office a call at 701-232-7705 or go to lillestolresearch.com.