Research and Clinical Trials at Northstar Medical Center
What is a Clinical Trial or Study?
A clinical trial is a research study that generally often investigates and compares two treatments and takes place at special clinics or Universities. A particular study example may compare the once daily pill Atripla to another HIV cocktail. Sometimes all therapies within the study are fully FDA approved and sometimes they are “partially” approved for another indication. In other words, a treatment may be approved for one type of patient but now being looked at for a different category or stage of the patient. Also, sometimes a treatment is “fully investigational”, not approved yet, but usually other studies have already been done to validate and that the treatment has a good rationale for studying it. In this case, smaller studies may have been done that appear promising.
When a patient enrolls in a clinical trial, he or she not only gains from getting access to cutting-edge treatment, but also contributes to the wealth of knowledge that other future patients and practitioners use to learn about treatment. Thus the patient in a study helps and makes significant “worldly” contributions.
Who Can Participate?
Both patients from Northstar and patients from other practices or clinics are welcome to inquire about participating in a variety of studies.
Are The Treatments Provided?
When enrolling in a study, patients have the potential of obtaining free treatment, depending on the study. In “Naïve Patient” studies, in other words, patients who have never been on HIV therapy and are starting treatment on first treatement, these types of protocols provide the complete HIV treatment cocktail for free and some physician visits may be included (specifically those paid for by the sponsor). In the situation where a patient is getting a new treatment, after failing his/her current cocktail, or whose viral load is > 1000 while on treatment, the study drug is provided, sometimes with other meds but, in most instances, the patient’s insurance or ADAP would cover the remaining backround treatment.
Northstar Clinical Care
Unique to Northstar, consistent with a philosophy of providing the highest standard of care, our patients are more often seen by the physician then would be expected or mandated by the study. Northstar is known for its high quality, hands-on care and patients of Northstar or patients coming to the clinic to participate in a clinical trial have the advantage of gaining access to Northstar’s team approach. The physicians at Northstar are HIV specialists and are also able to help manage other medical issues. However, outside the normal protocol, and for other medical issues not related, those are generally needed to be covered by insurance.
Is There Payment of Compensation to the Patient?
Sometimes, when a study requires the patient to be in the clinic for several hours, the study may pay a stipend for the patients time. Also, in some cases, money for transportation may also be provided. In rare cases, when a study requires a full day at the clinic, more money is generally offered to the patient to offset that individuals time and service.