In this Sermo series, we’ve covered why you may want to do clinical research, and last post we discussed the qualifications to be a competitive clinical investigator. This installment will briefly discuss what your research site should have at its disposal to be credible.
Let me start by stating that if you want to just begin with post-marketing (phase IV) research and just be a participating investigator, you may need very little in addition to your extant clinical environment. This is commonly the route used by clinical practitioners to get early experience, but it is also important not to develop bad habits that will dog you if you want to move on. Indeed, if you intend to move into phase III and phase II and become a principal investigator, your site will need to be scalable and be rigorous in its standards and certifications. And early investigational product (IP) work at phase I levels is best left to extremely experienced and dedicated research facilities and beyond the scope of this introductory series.
Post-marketing trials are commonly done for a couple of reasons, and it would be wise if you figure out which reason is active. Commonly, you may be asked to be an “investigator” by a sales rep of an existing product. Playing to your ego is the name of that game, and these are often “seeding” trials. That is, they just want you to get experience with their product and hope that you will continue to prescribe it after the “research” project is completed. They will ask for only a few (5-10) patients with the condition of interest, and little, if any, in the way of inclusion/exclusion criteria or formal signing of informed consent prior to initiation. The forms are simple, and may even be web-based. You may be compensated modestly for completed “subjects”. These “trials” are of no use to you if you want to be a real PI.
If the sponsor is looking for truly expanded indications of an existing FDA approved product, you will likely be approached by someone more senior than your local drug rep, and ideally someone from their research division. The sales and research divisions of a pharmaceutical company are firewalled. Keep that foremost in your mind. True research work is not to be freely discussed with the sales forces, no matter how attractive they may be.
To become a progressively more accomplished and regarded investigator, you will eventually need dedicated staff and space to conduct the research work. Early on, this can be hybrid staff and space. Select individuals who are bright self-starters and have just the right amount of obsessive-compulsive disorder that can be harnessed. Attention to detail is critical. Read that again. Once you move on to phase III work and beyond, it will be very helpful if your now dedicated clinical research coordinators (CRC) have been formally certified by a recognized entity, like the Association of Clinical Research Professionals, but others are available as well.
Besides dedicated space for blood drawing and visits, you will require secure storage for the investigational product, with access limited only to those who need to have it. Centrifuges, refrigerators, freezers with monitored temperature (ours alarm and send messages if temperature excursions go outside the acceptable range), materiel accounting strategies and software (even simple ones like Excel™ or Numbers™ may suffice) will be required with increasing sophistication commensurate with the trials you may do. The important thing is to start with simple trials (next Sermo installment in this series) and scale up as desired. If needed, the sponsors may supply you with the computers and equipment to do the study, and sometimes you may be able to keep the equipment, especially if you have done well (defined in the next installment in this series) and they intend to use you again! Having fast and secure internet access and dedicated working space for the study monitors who visit your site during the course of the trial are definite pluses to make your site stand out.
If the sponsor or the contract research organization do not know you, or they realize you are new to clinical research, they will likely do a site visit to make sure you are who you say you are, and your facility and staff are as you have indicated. They will pay extremely close attention to your procedures for securing the IP and the data acquired. You will have plenty of warning to prepare for their visit. We will talk more about site visits and audits next time when we will discuss how you get the trials in the first place.
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.