We recently interviewed Hakim Mohamed on the current challenges facing clinical research sites, and how the sites are responding. Mohamed is the Co-Founder and CEO of One Source Clinical Management (OSCM), with several clinical research sites. Prior to founding OSCM, Hakim served as Administrator and CFO with Synergy Clinical Research Centers, and Privacy Officer with Pacific Health System. Before that, he held senior positions with Bayview Behavioral Campus, San Clemente Hospital, and California Pacific Medical. Hakim lives in San Diego, CA, USA.
Teresa: I noticed that you’ve been speaking at conferences recently. You just spoke at MAGI in Boston. What have you been talking about?
Hakim: This time around, I had two topics. One is patient recruitment. I’m not the kind of guy who focuses on how to get patients in the studies. I focus mainly on how the patients should be treated once they are in the study. I’m starting to advocate for a patient-centric approach for patients before they come to the study, while they are in the study, and even after the study.
Teresa: What do you see as some of the main challenges that the clinical research sites are facing today?
Hakim: As the owner of a site, I’m feeling the same challenges that everybody is. I can give you three major ones. One is that the sites have been asked to do more for less. Sites now are being told to do multiple what I call “admin” tasks, meaning no patient contact tasks, like training, or training after training, meetings, webinars, all the things that study coordinators have to add to their workload. This keeps them away from doing what they are supposed to, which is to look for appropriate patients that meet the criteria, schedule the patients, and conduct the visits. But if you are taking away half of the study coordinator’s time to the non-patient activity tasks, you really are putting a burden on the sites.
That has a financial impact on the sites because now the study coordinator who was supposed to screen an average of one to two patients a day, maybe now has only the time to screen two or three patients a week. And by not screening enough patients, this will have some negative impacts on the site’s financials.
Teresa: How are the sites responding to these challenges? Are there any changes in the demography of sites– who’s surviving and who’s not?
Hakim: Well, the sites have to adjust. Like everything in life, you have to adjust. What the sites are doing, and I happen to be one of them, is that we created research assistant positions. While the study coordinators are busy doing the non-patient activities, the research assistants are helping screen patients on the phone, at least doing the legwork for the study coordinators. When the study coordinators have the time they will do just the final screening on the phone, or some patients are being already scheduled if the research assistants feels that the patients may meet the criteria. So, we help the study coordinators by doing the legwork for them, so they don’t have to spend as much time looking for patients.
Teresa: How are the small, independent sites doing amidst these changes?
Hakim: Sadly, some of them didn’t even survive to be able to make any change. We’ve seen a lot of sites are merging now. If it’s a single doctor site they may be looking at other colleagues who are doing research and trying to merge their resources. Instead of having four study coordinators, they may be able to have only two between the two of them, and then create more positions for support staff. So, we’ve seen a combination of sites failing and sites merging, and sites who have been surviving. They barely survive. Their profit is shrinking. It’s just a matter of time how long they can handle it. I don’t have the answer for that.
Teresa: Are trials still being done in the community-based physician office? Are they still combining with other physicians to do research?
Hakim: Not anymore. And the reason, it has nothing to do with research. It has a lot to do with the physicians also. In the past, physicians were able to accommodate research by having a bigger space. But, with healthcare also having its own challenges, doctors are bringing other doctors to share space with them, and by bringing other doctors to share space, now you don’t have adequate space to also conduct clinical research. So, you are having to choose between bringing on a physician that can help you with your own overhead as a physician, or conducting clinical research which needs the space. Some doctors are able to do that. Some doctors have chosen not to do research any more, and to bring in more physicians to help with their overhead.
Teresa: There’s a lot of talk in the clinical trial media about patient recruitment and enrollment. Is this problem getting solved?
Hakim: No, unfortunately not. By the way, this is not a today’s problem. This problem existed since clinical trials existed. In the past, the challenge with patient recruitment was due to non-awareness of research. People were not aware of research, so therefore, sites who have doing this for 30, 40, 50 years, had challenges just because patients did not know much about research. Now, finally, through social media and the very hard work from all parties, sponsors as well as sites and doctors, people are aware of research, clinical trials. They’re aware of the benefits of clinical trials. The awareness is there.
It is a different challenge in patient recruitment today, which is that the protocols being written are complex. They are difficult to find patients for. The inclusion and exclusion criteria as of five years ago used to be an average of five to 10 pages long. Now on some trials there are 30 to 50 inclusion/exclusion criteria. That’s a lot of criteria to meet.
Teresa: Do you have a site network?
Hakim: No. My sites are very independent. They are not site networked. I own all of them independently.
Teresa: You’re very much an entrepreneur. Do you see other entrepreneurial opportunities in clinical trials?
Hakim: Whomever wants to start a new site, they better have a Plan B and Plan C. Either be part of a medical group already and that way they can have research as an arm of that medical group, or they have other businesses that can be affiliated to their research. But just to go and open a site single handedly, it’s a suicide mission.
REFERENCE: Clinical Research Currents, May 17, 2019. https://bit.ly/2VMKkFZ