By: Steven Nissen, MD
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We have very good treatments for some conditions — but unfortunately, not for all. For example, statin drugs may lower cholesterol and risk for heart disease in the majority of patients. But for those patients who don’t benefit from these drugs carry a residual risk. We need to develop new therapies to help patients who do not achieve the maximum benefit from these drugs.
Physicians who are on the cutting edge of medicine provide the newest or best therapies available. Though we have made strides, there is more we need to do. We can only advance research when altruistic patients decide to participate in studies. When it comes to research, the gold standard (or what you could call the Supreme Court of research) is the randomized control trial (RCT).
Benefits of randomized control trials
Participants in a RCT are randomly assigned to a treatment group (i.e. half may become part of a placebo group while the other half may be involved in active treatment). These studies often go on for a number of years, and they may need considerable sacrifice on the part of participants.
There are tangible benefits of participating in a trial other than helping humankind. Patients may get access to the newest treatments available. Studies have shown that even the patients in research trials who get placebo (no active treatment) have better outcomes than people who did not participate in trial at all.
The reasons may be tied to a number of other factors. First, these patients are monitored very closely and their lab values checked often to make sure they are doing OK and to be sure the data is accurate for the study. These patients get extra attention of caregivers by virtue of participating in a study, one of the advantages to being a trial participant. And much, if not all, of the cost of the doctor visits are paid for by the trial.
Advancing patient care for all
Research is how we advance care. It is an important part of what we do, and we could not advance the science without the partnership of patients.
If you are interested in volunteering for a research study, it is important to consider this commitment carefully. The research team will go over the informed consent, describing the trial in full, any risks and benefits to the trial, and the time commitment involved. If you aren’t sure you can stay in the trial to the end, it is better not to start the process. If you end up dropping out, it actually undermines the research.
We have several exciting studies underway, which include a number led by Cleveland Clinic. ACCELERATE is a study of a new HDL-raising drug that lowers LDL. In preliminary studies, it increased HDL by > 100 percent. The results are expected by late 2016 and include a total of 12,000 participants.
Another study underway involves a modified fish oil that lowers triglycerides linked to heart disease. It has not been rigorously studied in patients with high triglycerides and low HDL to see if it is a more effective form of fish oil. This study, which includes 13,000 patients, will go on for many years.
Research has always been critical to new developments in medicine. Today, these types of studies are often done globally. Research is now global because cardiovascular disease has global significance.