Koski et al. published a perspective piece in the NEJM titled Accreditation of Clinical Research Sites—Moving Forward (June 28, 2018). The authors described their progress in developing standards for clinical research sites as the first step in accreditation. They initially emphasized quality management; protecting trial participants’ rights and well-being and facilitating reproducible trial results.
I have been working with The CUSP Group, LLC a consortium 22 large tertiary community uro-oncology practices that are facile in conducting all phases of research. Arletta van Breda RN, MSN, CCRC, CIP, Director of Clinical Research Operations, at CUSP demonstrated this constant focus on quality management. She described the continuously evolving mechanisms by which CUSP confirms the correct diagnosis and staging of subjects participating in all GU oncology studies conducted over past 7 years. “Data granularity, as well as data fidelity, must go hand-in-hand with patient/subject protections”.
Not only did the CUSP Group set up processes to align with the new ICHE6(R2), but its process for confirming critical data can teach all of us a lesson. They do not evaluate potential trials to determine whether it is a registration trial, instead their philosophy is that every trial in which a subject participates is important and the data should be complete and correct. Even a single blood draw is a “gift” the research subject gives to researchers. Ms. Van Breda considers it her team’s responsibility, both at the consortium and at the study site level to be sure the data is correct, so the results can contribute to better cures for patients. Additionally, Dr. Neal Shore, Founding Director of CUSP, underscores that the magnitude and significance of data arising from these trials are enormous given their analytical validation, clinical validation, or clinical utility objectives. “The science cannot advance if the data is not rock solid”.
In the era of patient-centric research discussions, this is a perfect example of how the patient should be front and center. Patients’ contributions to research are priceless. The entire clinical research community is responsible to assure the data we collect is correct, the processes follow the protocol, and the controls used to assure subject safety are appropriately monitored, not just checked to confirm a data field was entered.
These same principles form the basis for ICHE6(R2), the new definition of Good Clinical Practice for clinical research. It provides the guidance for all trials involving human subjects. If we conduct research using human subjects, it is our responsibility to make sure the study is conducted correctly, regardless of whether it will be submitted to a regulatory agency.