Clinical Researcher—February 2018 (Volume 32, Issue 2)
Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP
Quality research sites make the clinical research enterprise work. Without research sites, there is no proof-of-concept possible after the years of research and development (R&D) done by the amazing biochemists and bioengineers that precede launching a clinical trial.
Where I work, our company’s vision is to decrease the industry’s enormous R&D costs by finding and developing more physicians willing to engage in research. There is an ongoing and growing need for investigators capable of enrolling well, enrolling quickly, and producing high quality data. Investigators adept at clinical research decrease each clinical trial’s cost by millions of dollars.
Our CEO works tirelessly to find physicians, group practices, and hospitals that will engage in research. This is shockingly harder than it sounds. When it happens that one of these entities (I’ll call them “clinics” moving forward) wants to conduct research and partner with us, my job as Chief Implementation Officer is to deploy the various departments in our company to:
- train the medical providers on exceptional Good Clinical Practice and what it means to be a quality investigator,
- train the clinic personnel on clinical trials and the benefits that they may offer to their patients,
- set up the clinic physically to conduct trials,
- provide the clinic with feasible trial opportunities,
- and place a well-trained clinical research coordinator (CRC) at the new research site.
Some of our site startups have been impressive successes, but I must be honest that the greatest lessons learned were from clinics that failed either temporarily or permanently.
Lesson 1: Have a small but diverse team conduct due diligence.
Think of this group as a task force. Keeping the group small ensures that resources are maximized, but the real lesson here is the diversity. It is easy for a person with a sales mentality to preferentially see the positives, and for a visionary to see the big picture potential and miss the operational details. Bringing diversity of thought by including an operations manager capable of seeing potential obstacles and a finance person capable of creating the analyses that will drive the task force’s goals is a necessity.
Lesson 2: The clinic needs to invest some of its own money or resources.
One of our most spectacular failures involved a clinic that wanted to add a source of revenue through research but didn’t want to invest any of its own money or personnel. Because we saw so much potential in the clinic due to size and specialty, we provided all the capital and personnel. Despite a highly experienced and ambitious CRC onsite and an incredible pipeline of trials, the site failed in less than a year because we only had the commitment of the singular administrator who engaged in the partnership with us at the beginning. None of the physicians and none of his operations people ever bought into the concept.
That segues nicely to…
Lesson 3: Determine the internal champion(s) at the clinic and their level of influence.
Administrators may want additional revenue but have no influence over the behaviors of their physicians (or even their own staff). Physicians may want to offer a service to their patients and the field of medicine but not have the influence to overcome administrative hurdles. Or, in a third scenario, administration and physicians may be in unison but have an office manager who actively (but covertly) fights change.
A subsection of project management is project stakeholder management. Stakeholders are the people who “may affect, be affected by, or perceive [themselves] to be affected by” a project.1 My experience in project management strongly supports the idea that we must “consider others who have an interest in the project and, by definition, are also stakeholders. These stakeholders are outside the authority of the project manager and often present serious management problems.”2
“Outside the authority of the project manager” is precisely why influencers throughout the clinic need to be engaged. Often, office managers (for example) are afraid of change. Without having been part of the discussions administrators or physicians had regarding research, they feel blindsided, with no feeling of ownership and very little direction. They see more risk than reward.
Partnering to create a new research site becomes nothing less than a Sisyphean task if administrators, physicians, and office staff are not willing to engage in research, or if an internal champion cannot bring them to agreement on the endeavor.
Those are the most make-or-break lessons. Operationally, a few more are helpful:
Lesson 4: Separate scorecards by site.
We keep weekly scorecards on each research site we run, based on the pro formas and budgets we set for them. Scorecards include revenue from patient visits, from startup activities, and per headcount; the monetary value of enrolling trials and those still in the Business Development unit’s pipeline; and the number of protocol deviations the sites are generating.
In the past, we reviewed these numbers at too high of a level. For example, if we had three research sites in a city, we reviewed the scorecards at the city level. This method seemed like an easier, high-level view for our leadership team, but has the potential of concealing the truth. High-performing sites mask the flaws present at low-performing sites, so my advice is to keep metrics individualized by site, even if they share personnel.
Lesson 5: Ensure Business Development’s trial pipeline can support the site.
Specifically, if the new research site is near an existing one (sometimes even just in the same state, for Phase II trials), this can decrease trial awards. Additionally, it may be that Business Development sees many trial opportunities in a medical indication, but without experience in that indication, isn’t aware that the trials are so similar or so difficult that they will not be feasible at the new research site.
Lesson 6: Place a certified CRC in clinics with no onsite research manager.
A clinic new to research needs at least one person to develop and manage relationships and research-critical skills among new and existing investigators and office personnel. Potentially, this could be handled by a local (offsite) manager if needed. What cannot be handled by anyone else is quality. Quality conduct of clinical trials happens in real time, and 11 years of hiring CRCs tells me that the odds of success in having quality data are far higher when we hire or relocate a certified CRC for sites in need. Seasoned investigators can train new CRCs, but seasoned CRCs are often the ones to conduct the ongoing, real-time training of investigators.
Lesson 7: You cannot over-communicate with stakeholders.
Consider frequent communications about processes, successes, and obstacles. Share these communications with engaged physicians, relevant administrators, and—heeding my advice from Lesson 3—(official or unofficial) office managers.
My sincere goal is that more medical providers at all skill levels and in all medical specialties become involved in research so that current patients reap the potential benefits, future patients have better treatment options, and medications can be prescribed sooner and at less cost. If you can help by expanding research in your areas, you have my full support.
- Sowden R. 2011. Managing Successful Programmes (MSP®) (4th edition, p.59). The Stationery Office. See educore.com.tr/wp-content/uploads/2014/08/MSP-2.pdf
- Cleland DI. 1986. Project stakeholder management. Proj Mgmt J 17(4):36–44.
Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, (firstname.lastname@example.org) is the Chief Implementation Officer and a member of the Quality Assurance and Compliance Committee with IACT Health in Columbus, Ga.