In the fourth post of our series on site empowerment techniques, let’s take a moment to recap where we’ve been and where we’re going. In our initial post, we set the stage by explaining the concept of empowerment in general and how adopting empowerment techniques could transform traditional and sometimes less than productive relationships between sponsors/CROs and sites. We delved further into the theory and practice of site empowerment by looking at the ultimate goals the key stakeholders were trying to accomplish, what typically gets in the way of delivering successful study results and why a new, different and more empowered approach to sponsor/CRO relationships is needed. We then started exploring specific techniques that could be applied at the study feasibility, site selection and study start-up phases of the clinical trial process.
Now, we move along by considering additional techniques that sites can apply during the all-important site training activities that take place during the start-up process. As we have done with the previous posts, let’s take a moment to contemplate what typically happens once the study start-up process is completed.
The typical process
Upon successful budget and contract negotiations and IRB/EC approvals, the site is ready to be initiated. Depending on the sponsor’s or CRO’s SOPs and the prior experience they have with the site, this might entail some combination of web-based or face-to-face protocol and GCP training activities, along with a site initiation visit (SIV). The non-empowered but compliant site is often at the mercy of the sponsor or CRO to complete countless hours of standard GCP training or attend protocol-specific web-based training, which may or may not be geared to their needs.
Training provided by the sponsor is often generic in nature and not necessarily role-based (e.g., customized to what the PI vs. CRC vs. research pharmacist, for example, needs). Further, the site initiation visit may be a repeat of other training and is often driven by the CRA who may be more or less well prepared, so the site is never quite sure of the quality of the training they will receive. The site in turns proceeds to implement the study only to find they are faced with numerous data queries, monitoring visit findings and potential protocol deviations. Addressing these issues after the fact not only takes time, energy and resources, but also detracts from enrollment efforts, and more importantly puts the sponsor’s end goals of timely high quality data (and potentially patient safety) at risk.
What would an empowered site do?
Provide Relevant Training Certification
By now, it should be more apparent that the empowered site does not leave the critical training activities to chance. With regard to standard GCP training, the empowered (and well-educated) site recognizes that there are various industry initiatives (e.g., TransCelerate BioPharma and Investigator Databank) aimed at enabling mutual recognition of standard GCP training across sponsors. Rather than merely responding to requests to complete the GCP training, the empowered site provides certificates of prior GCP training and mastery of GCP requirements to the sponsor or CRO and negotiates acceptance of this information, regardless of whether the sponsor or CRO is a member of these organizations. The site zealously makes a case for the fact that they were selected based on their experience and qualifications, and proactively provides evidence that they have completed standard training so that the sponsor/CRO accepts this and ultimately recognizes the site’s time is better spent on the protocol-specific training.
Fully Understand Protocol Complexities
The empowered site also recognizes that the number one finding from FDA inspections is a failure to follow the protocol (study plan), so they want to ensure they are fully informed about the protocol nuances and complexities. Towards that end, the empowered site undertakes two key activities to ensure they are fully prepared for study implementation:
- Prior to the SIV or investigator meeting, the site conducts a dry run of the protocol. By putting a mock patient through the protocol, the site uncovers aspects of the protocol that are not clear. Or, they realize they may be missing certain information, tools, equipment and so forth. The empowered site creates a list of questions they want to be sure they have clarified before they test out the protocol on a real patient.
- Having completed the mock patient visit, the site proactively shares the list of questions with the CRA in advance of the SIV (or investigator meeting). The site may also craft their own initiation visit agenda whereby they organize which information is needed by which functional group/role so that the time of the staff is optimized and that each individual walks away from the training confident with all of the information they need.
With such a proactive approach, the site and CRA can both breathe a sigh of relief that they won’t have to sit through a “death by PowerPoint” presentation. Further, in today’s era of risk-based monitoring, the empowered site, through these efforts, reinforces to the sponsor and CRO that they are focused, preventing errors and deviations, and that they take their responsibilities for ensuring quality in trial conduct seriously.
Check out the final article where wrap up our site empowerment series by looking at study management empowerment techniques.
Site Empowerment Webinar
Watch the on-demand webinar, Site Empowerment – Envisioning New and More Effective Ways to Work with Sponsors and CROs.