Ileana L. Piña, MD, MPH

Disclosures

January 25, 2016

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Ileana L. Piña, MD, MPH: Hello. I'm Ileana Piña from the College of Medicine at Albert Einstein in the Bronx, and I'm the associate chief of cardiology at Montefiore Einstein Medical Center in the Bronx.

This is my blog—and this is a very serious blog because it comes from discussions not only with companies but also with investigators, many of them my own colleagues, about the frustration that we are feeling with the lack of good enrollment in clinical trials.

We have to thank clinical trials for getting us to where we are today both in medications and in devices. Even though I'm a heart failure doc, this really applies to all areas of cardiovascular care. Why are we doing so poorly in enrollment?

Certainly being the principal investigator is a very, very critical obligation. Principal investigators very often will back away from the trial once it's ongoing and allow the coordinators to do the majority of the job. But I personally feel that the hands of the principal investigator must be there and must continue to be there for the duration of the study because complaints later on are not going to fix poor trial conduct. We can do all the beautiful designs, but the trial conduct is where the metal hits the road.

Second: Why are we sending so many trials abroad? It's because we're not enrolling in the United States. Is there a differential in payment systems? I know centers where no matter how many trials an investigator has, they don't get credit. We are facing more and more pressures—even inside the large academic institutions—to produce, and to produce revenue, and to produce payments by seeing more and more patients.

I don't have to tell most of you who take care of the heart failure world, these are very complicated and sometimes very, very sick patients who do require time and effort in a study visit, maybe longer than what you would think. How about if, when you create a budget for the trial, you include the visits as if they were the visits into your clinic, which you would bill for separately anyway? How about giving credit to the investigators for those visits and for the time spent in the trials? After all, there are funds coming into the center or into the private office for the trials.

Finally, what about disparate groups? What about women? African Americans? Hispanics? Asians? Our numbers of minorities are sometimes woefully low. It may take a little bit more effort to think about those patients who do represent the minorities and to get them involved. How can we honestly say that our drugs work throughout if we haven't even tested them in these different groups? As a Hispanic, I do my best to get my Hispanic patients involved and get the public to understand that trials are important. Often patients may think that they are guinea pigs, and it is a very cultural difference. I know with Hispanics, [being a] guinea pig is something to be feared. Maybe we need more literature explaining to our minority groups why we do clinical trials, reminding them that often even the placebo groups in these trials do better than the general population. Why? Because they have an entire team taking care of them and watching after them.

So I'm asking this audience to do your part, as you can, to enroll, to refer your patients to centers where trials are being done for enrollment, and to try to calm that fear that we're not [using them as] guinea pigs—that we are fully consenting and explaining the trials to the patients. I think we will have much better trials. I think we will have stronger trials, and finally we're going to have some answers.

I thank you for being with me today. Ileana Piña, signing off.

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