This is perhaps the most important installment in our series on becoming a clinical researcher. In my prior posts, we have covered why one should consider doing clinical research, your optimal credentials to be accepted as an investigator, your site’s requirements, and how to find the trials. This is the money installment where all of the preceding discussion culminates in your ability to deliver the subjects you indicated to the sponsors and Contract/Academic Research Organizations that you could and would. Not only does your remuneration depend on being successful in this aspect, but your obtaining future research work as well. If you fail (badly) to deliver, a second date is much less likely. So if you have been following along with this series, this is the one to pay the most attention to if you are indeed serious about becoming a successful clinical investigator.
First, be picky. Do NOT accept any clinical trial offered to you unless you are satisfied that you actually have patients that will qualify for the study. Clearly you have to pay attention to the Inclusion Criteria (what elements are sine qua non for identifying appropriate subjects), but even MORE important, pay attention to the Exclusion Criteria (the disqualifying elements that preclude randomization of the potential subject). You initially will be very excited to participate because you have many patients with the condition of interest, but it will be the exclusion criteria that will limit subjects to those that actually qualify for randomization. Inadvertent inclusion of non-qualifying subjects that are detected during research monitor visits or during an audit are major black marks on a site that call into question your site’s suitability for continued participation and future trials. Although your clinical research coordinator bears much of the responsibility for sorting out subject eligibility, it is your signature on the FDA1572 that makes you ultimately responsible for such protocol violations. The ritual known as obtaining informed consent is absolutely critical in this process and can make or break your site. Your research coordinators have to be meticulous and rigorous in this process if it is part of their job, but again, you also will be signing the document and it may be optimal to have you, as the principal investigator, obtain consent from the potential subjects.
Although you will have many patients that come to mind with the condition being investigated, having a searchable database is invaluable, especially if you can search by diagnosis, CPT or ICD 9/10 codes. One handy observation is that although our colleagues may sometimes be a bit late with clinical documentation, they are almost never late in submitting billing codes. So, for example, if there is a study looking for patients with acute coronary syndromes, the billing software can flag those patients with those codes for your review as the PI.
Colleagues can be invaluable, but politics can be a formidable obstacle that you will need to sort out. If you have partners that are in the same specialty or even in a multispecialty group, some revenue-sharing arrangement will enhance the likelihood of internal referral. The caché of doing clinical research may enhance the practice profile and be a further incentive to colleagues contributing their patients to the common success.
Or not. If you are in a competitive environment with other specialists with significant numbers of patients with the condition under investigation, it may be very difficult (read impossible) to have any patient referrals to your site unless you are very friendly with other groups. From their perspective, there is little to be gained and much to be lost if their patients see your group as being more advanced or prestigious than their current providers. Site selection decisions from sponsors/CRO/ARO’s often do not take into account the local politics when identifying a research site. Selecting two competing sites in the same catchment area is a recipe for a Hatfield-McCoy scenario. As groups coalesce under the aegis of an ACO or hospital system, it may actually enhance the ability to find cooperating larger sites as the abrasive aspects of the local political environment are mitigated…maybe.
Rewards can be used as well for office managers, hospital based clinical coordinators, or nurses who see potentially eligible patients and refer them. Simple rewards can be Starbucks or iTunes cards for good leads, and act as a positive reinforcement for future referrals. This also assumes that you have done some in-service education or a conference for your colleagues, emphasizing the science, clinical importance, non-proprietary aspects of the investigational product, and especially the inclusion and exclusion criteria. The sponsor may have some turnkey materials that may be suitable for such programs. Find out and use them.
Advertising in my experience has been of limited value. Many people respond but very few turn out to be ultimately eligible, and much valuable time is spent sorting out inclusion and especially the exclusion criteria. It does serve a positive marketing role to raise awareness of the condition and of your group, but, as a specific recruiting tool, is of limited value. If you can identify an enriched environment in which to advertise rather than general radio, TV or newspaper pieces, that may something that you can present to the sponsor for a budgetary amendment to cover the incremental cost.
But there is an exception to this marketing caveat. Some sponsors have utilized intermediaries to do targeted advertising with toll free numbers, websites or social media sites. In this way, potential patients or often their family members can explore participation, gaining hopefully useful information that may help patients, and the site managers can carefully cull respondents for the pertinent inclusion and exclusion criteria. They can then refer this enriched pool of ostensibly eligible individuals to the nearest research site for further evaluation, at no cost to the site itself.
In about a month, the next installment in this clinical research series will cover subject retention, another extremely important part of the process that will enhance your profile and continued success.
Dr. Irving Kent Loh MD, FACC, FAHA (Epidemiology & Prevention), FCCP, FACP is a board certified internist and sub-specialty board certified cardiac specialist with an emphasis on preventive cardiology. He founded and directs the Ventura Heart Institute, which conducts education, research and preventive cardiovascular programs. Dr. Loh is a former Assistant Professor of Medicine at UCLA School of Medicine. He is Chief Medical Officer and Co-founder of Infermedica, an artificial intelligence company for enhancing clinical decision support for patients and healthcare providers.