The Pulse on Study Conduct
Evaluate New Investigative Sites Holistically
Investigational sites must be evaluated based on each element of contribution to form a fully dimensional picture for study consideration. Some sites excel at recruitment, but lack therapeutic expertise. Some sites with inexperienced staff have tactical/logistical expertise. Those sites lacking in some areas may tip the scales in their favor with other valuable strengths. We may miss out on good sites if we do not consider the entire picture.
While research experience is an essential factor, it is not the only factor when considering investigators for studies. It is not a mere yes-or-no checklist, with cut-and-dry questions regarding staff research experience. You owe it to the study, and to the investigational site, to dig deeper than an initial dismissive reaction when evaluating an inexperienced investigator. You should consider factors such as weighing individual value against overall research experience. Look at their clinical experience in the therapeutic indication. An investigator may be a clinical expert in the disease under treatment with little-to-no research exposure, so you must ask the critical questions such as, is the study design straightforward enough to justify the clinical expertise in lieu of clinical trials expertise? Has the investigator aligned themselves with a mentor who can advise on the responsibilities and role of an investigator? Has the investigator completed GCP and human subject protection training? Has the investigator acquired an experienced study coordinator or have access to credible support staff? How much have the staff accomplished along the training pathway to compliance? These preliminary findings can greatly influence the decision to use a new investigator.
There are inherent qualities that make the fabric of a great investigator; humility, diligence, compassion, willingness to seek knowledge and accept assistance and take all necessary steps in pursuit of this massive assimilation. All adjectives that describe an experience with Dr. Smith.
Dr. Smith’s (name changed for story) transition to clinical research read like textbook instruction on how to become a successful principal investigator. His transparency and integrity helped me to be more open in my consideration of new research sites/staff during site selection and to never dismiss someone for lack of experience alone.
I came to know Dr. Smith many years ago during a primary care hypertension study. His site was being considered as an add-on site because the study enrollment was critically behind schedule. The project need for additional sites/subjects was so great that they were considering sites with no prior history with the sponsor, including inexperienced investigative sites. The first couple of sites I assessed were not appropriate for the study, and I did not have especially high hopes for a successful evaluation of Dr. Smith’s site due to his lack of clinical research experience. What I found after concluding the evaluation visit with him was the direct opposite of my inaccurate, preconceived misgivings.
Dr. Smith was a busy primary care physician who had been methodical in uncovering what it truly meant to be a principal investigator — the commitment, the level of education, the responsibilities and the fiscal and clinical demands of attracting and sustaining a clinical trial, to include staff, infrastructure and equipment.
Dr. Smith spent an hour discussing his plan for patient enrollment and produced a redacted list of patients from his database to confirm access to potential patients. He was so scrupulous with his site information that it was as if he had been coached on the most effective processes for site creation and presentation. To bring in a clinical research consultant to teach him the correct order of establishment from the beginning was a significant investment in training, a demonstration of due diligence far beyond what was expected.
Dr. Smith reviewed the study design with me and understood the concept of clinical research vs. clinical practice. He verified that they could accommodate the schedule of assessments, as many of them were already completed as standard in his clinic. He was familiar with the class of drug and genetic predisposition to the disease state, far better than some of the more experienced investigators in the trial.
The study design was straightforward and perfectly complimented the standard of care and his level of experience. It was ideal for a new investigator as it allowed for therapeutic expertise contribution that did not overshadow simple inexperience with its complexity.
I was impressed with his extensive efforts to set up the ideal research site, his diligence in completing his research education and the level of preparation taken to prepare his site staff for clinical trials. Dr. Smith’s financial and personal investments in this role thundered due diligence more loudly than an experienced research site resting on its laurels. I recommended his site for the study, but left the project before I confirmed if it had been selected. It would have been a missed opportunity had they not been chosen by the sponsor.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. She also is author of the novella Clinical Research Trials and Triumphs. Currently she works in relationship development/study startup in the CRO industry. Email firstname.lastname@example.org or tweet @ebwcra.