Advice for Getting a Start (or Upping Your Game) in Clinical Research
A veteran physician researcher shares tips on getting started in clinical trials, obtaining funding, following regulatory standards and making your research efforts a success.
For clinicians looking to diversify their careers, few moves are likely to prove as rewarding as getting involved in clinical research. But how do you get the ball rolling or build on early research efforts?
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To explore that question, Cleveland Clinic Cardiovascular Medicine Chair Steven Nissen, MD, sat down with A. Michael Lincoff, MD, an interventional cardiologist who also plays several key roles in Cleveland Clinic’s enterprise-wide research efforts, including Director of the Center for Clinical Research in Cleveland Clinic’s Lerner Research Institute and Director of the Cleveland Clinic Coordinating Center for Clinical Research (C5Research), a 27-year-old academic research organization that plans, coordinates and manages multicenter clinical trials of new pharmacologic and device therapies. Below is an edited transcript of their conversation.
Dr. Nissen: Mike, imagine that you’re approached by a physician in practice who’d like to get more involved in research. What advice do you give about what it takes, how to get started or how to step up one’s level of research activity?
Dr. Lincoff: To get started, it’s helpful if you have some publications under your belt or develop a reputation for being able to produce in the field. One way to do this, before taking on prospective studies, is to do observational studies using your own institution’s medical records to answer questions prompted by your experience with your own patients. The result may be a case series or something similar that gets you published so you can start to become known. That can create opportunities to interact with people who can facilitate your participation in multicenter trials, either industry sponsors or representatives from academic research organizations.
Most trials, particularly in cardiology, tend to be multicenter because of the numbers of patients needed, but for questions that are highly focused or involve specific patient subsets, an investigator-initiated trial at one’s own institution can be appropriate. Of course, there’s infrastructure required to do clinical research. Beyond the regulatory requirements of submitting to an institutional review board (IRB) and other regulatory bodies, there are activities related to consenting patients, enrolling them into the study, performing the specific procedures or assessments as part of the study….
Dr. Nissen: And if it’s a multicenter study, there’s often a case report form that has to be completed.
Dr. Lincoff: Correct. A lot of reporting is required. In addition to the case report form, there’s reporting of adverse events and reporting of all the data to the trial’s central data center. So at some point — maybe not for a small study or for your first multicenter trial — you’ll need to develop an infrastructure, which usually involves hiring one or more research coordinators, who are usually nurses.
That’s generally funded from the revenue stream from enrolling patients in trials. It can sometimes be a chicken-and-egg situation where you can’t get the revenue needed for a coordinator until you hire a coordinator, which is why some institutions offer recruitment packages for physicians that provide a couple years of salary support for a research coordinator to help get these efforts off the ground. For this reason, access to some infrastructure for developing research can be a worthwhile point of negotiation for physicians starting in a new position.
Dr. Nissen: Most physicians involved in multicenter trials aren’t independently publishing, right? They’re taking part as participants, not so much as leaders in the trials. So how do they make it known that they’re interested in participating in, say, an industry-sponsored trial?
Dr. Lincoff: Again, it’s a matter of how you get started. Sometimes it can stem from relationships with representatives from relevant companies. Interventional cardiologists can get to know and speak to the representatives from companies that produce stents and catheters, for example, and indicate their interest in being thought of the next time the company is considering a trial. The reps will often communicate this to their research groups.
Another option — one with particular appeal for those with an academic esprit de corps — is to get involved with an academic research organization like our own at C5Research group at Cleveland Clinic, where we coordinate multicenter trials and have lists of investigators and sites we’ve worked with for years on various trials and whose areas of expertise are known to us.
Of course, attending the major cardiovascular conferences and meeting up with colleagues involved with these organizations is also a good opportunity to say, “Look, I’m interested in doing these kind of trials. I have resources to do it. This is the patient population I see.” At C5Research we’re always looking for good sites to be involved in trials.
Dr. Nissen: Trial sponsors will often want to vet the site. If you’re just getting started as a site and you don’t have a huge track record, what are sponsors looking at when they visit your site? What will make them confident you can actually get the job done?
Dr. Lincoff: Generally they’ll send surveys specific to particular projects. So if it’s an acute coronary syndrome [ACS] trial, they’ll want to know how many ACS patients you see in a given week or month or year. They’ll want to know how many of those patients undergo interventions, whether you use particular devices or particular antithrombotic therapies — whatever it is they’re studying.
They’ll also ask about your experience — or your team’s experience — in doing other trials. Everyone has to start somewhere, but most people aren’t starting in a vacuum. So if a particular physician is lacking personal experience, there may be others in their institution he or she can work with and perhaps share some needed nursing or administrative resources. So physicians working in larger organizations can often find ways to partner with others to meet requirements when they’re starting out.
Dr. Nissen: This is a highly regulated area, and the FDA supervises the conduct of trials for devices and drugs, which means that investigators and trial sites sometimes get audited. What do people need to do to stay on the up-and-up in that regard?
Dr. Lincoff: You definitely don’t want to look at the compliance requirements of clinical research as optional or a nuisance or just a pro forma matter. The regulatory environment has become stricter, and there are increasing calls from Congress and regulatory bodies for more enforcement against physicians and hospitals who don’t conduct research in a compliant fashion.
At our institution we’ve developed an educational program that we apply uniformly to all physicians. If a physician wants to participate in research, he or she is required to complete this program, which also needs to be renewed every couple of years, although the renewal can be done online. Generally, if an institution has an IRB, it will have training requirements for doing research under that IRB.
This is another reason why it’s important to hire or work with trained research nurses and coordinators who know the regulations and recognize the importance of compliance. But beyond that, there’s an explicit regulatory requirement for investigator oversight. It’s not acceptable for an investigator to step back and delegate all activities to a research nurse. If physicians want to do research, they have to participate and there has to be adequate investigator oversight. This is where investigators tend to get into trouble when there are inspections by the FDA, IRB or others, if it’s found they weren’t allocating enough priority or time to being part of the research.
Dr. Nissen: One of the things I’ve observed is that success breeds opportunity. If you become involved in a clinical trial and you’re one of the first and most rapid enrollers, you suddenly get on everybody’s radar as a site that can get the job done. That tends to bring in more opportunity and more trials. So clearly performance can be key.
Dr. Lincoff: Absolutely. All the research organizations and sponsors are running after those centers that enroll large numbers of patients, make it a priority to get started quickly, provide high-quality data in a compliant manner and consistently meet trial criteria without violating protocols.
That success depends in part on having some infrastructure but also on having priorities and setting your strategy. One of the biggest mistakes is to say yes to too many trials, to be overstretched so that you don’t have priorities. And that applies to you as an individual physician as well as to your colleagues or team, because it’s a rare trial where you alone will have enough patients to rapidly enroll.
The groups or departments that succeed are those that focus on a few studies that they believe are most valid for them, their interests and their patient populations. If a group identifies a trial as a strategic priority and everybody is interested in finding the patients and taking the time to consent the patients, success is likely.
Dr. Nissen: If a clinician is interested in participating in research led by our C5Research coordinating center, how should they go about identifying themselves?
Dr. Lincoff: They can contact us at 216.445.6396 or email@example.com and we’ll be happy to discuss what capabilities they have and which sorts of trials they might be suitable for.
Dr. Nissen: Does C5Research ever help sites get up and running, or do sites have to be really ready to go in order to participate?
Dr. Lincoff: Much of what we do with site coordination is helping sites deal with issues or barriers to enrollment, patient retention, and similar matters. So although we don’t have a formal blueprint of how to set up a research organization, we consider it a valuable and rewarding part of our role to work with sites to optimize many of their processes.
This post was derived from an episode of Cleveland Clinic’s “Cardiac Consult” podcast for healthcare professionals. For the full 17-minute discussion between Drs. Lincoff and Nissen, listen to the episode here or subscribe wherever you get your podcasts.