An interview with Alfonso Alanis, chairman and chief executive officer

What are the challenges to recruiting minorities into clinical trials and how will you address them?
There are a lot of myths about why minorities do not participate in clinical trials. But, a recent study by the NIH, published this month in PLoS Medicine, looked at a significant number of clinical trials where ethnicity was reported. What they found was that ethnic minorities do want to participate in clinical trials and that there was very little difference in the willingness of minorities to participate compared with non-minorities. The problem is that they do not have access to clinical trials. As underrepresented as minority patients are, the underrepresentation of minority investigators is much worse.We know that minority patients tend to go to see minority physicians for the most part in the outpatient setting. So, our strategy has been to enroll minority investigators.We have created a large database of investigators who belong to ethnic minorities or who have a predominance of minority patients.We can tap into these investigators to participate in our clinical trials.

Why is minority inclusion in clinical trials important?
As costs of development of new drugs continue to escalate, you want to be more selective with the population of patients that you study. Also, as prices continue to be under pressure, what would you rather do? Go out and study thousands of patients for which the efficacy of a drug would be 20% or 30%? Or, would you rather select a subgroup of those patients for which the efficacy might be 70% and the trial you need to do is smaller because you have a higher efficacy rate and therefore the statistical power you have is higher and the size of the population that you need to do the study is smaller? As the pharmaceutical industry faces all these pressures on prices, on escalating costs, on intellectual property and on safety, they probably are going to have to be pushed to be more selective.We need to convince large pharmaceutical companies that it is in their best interest to study a population of patients that is representative of how the drug is going to be used. It baffles me that you would test a drug in one population of patients and then sell it to another. You’re taking an exorbitant amount of risk and you have a lot of liability if something goes wrong. According to data from the U.S. census, in 2050, minorities will become the majority. That’s the reality of the makeup of our country. You are either going to be pulled into addressing the issue or you’re going to be on the front lines pushing to address the issue.

What is your vision for Anaclim?
One of the advantages of having worked for a major pharmaceutical company for a long time is that I have been on the other side of the table. I’ve heard all the excuses and all the bad news from CROs that I need to hear in my career. I have heard too many times that the study is going to cost more because we didn’t consider this, that or the other thing. Perhaps the most dreaded news is that the quality of the study was compromised for whatever reason, or the eternal story that the enrollment is not going the way we planned and therefore we’re going to take a hit on the timeline.We’re very cognizant of the issues in general with the CRO industry. As we move forward with our strategy to bring ethnic minorities into clinical trials, we are spending a very large amount of time—as we should—to make sure the quality of the work is outstanding. I expect that the more successful I am with Anaclim, the more the other CROs are going to start to emulate us, which is perfectly fine because that will address the issue of minority participation in clinical trials, which is really what we’ve set out to do. I welcome that.