By Ed Miseta, Chief Editor, Clinical Leader
The Pharmaceutical Outsourcing Monitor, produced by Michael Martorelli and the pharmaceutical services team at Fairmount Partners, has hit on some hot topics of late. Those topics have generated discussion, which in turn has resulted in Martorelli receiving a good amount of feedback from his readers. One of those hot topics has been the role of monitors in an RBM-dominated world and the shortage of qualified individuals available to accomplish the resulting new tasks. After publishing an article about this topic in the April 2016 issue of the Monitor, Martorelli took some time to address outstanding concerns in his mid-summer report.
A response from one reader addressed the concern of repurposing monitors to take a more active role in managing the way work is done at a site. Although those monitors could creatively help sites find new efficiencies in their processes, that may be a more challenging task than imagined, since providing monitors to perform clinical tasks is a profitable business for most CROs. “As a result, CROs tend to have very little interest in showing sponsors how they could reduce their use of monitors for routine tasks. Instead, they repurpose them to do more things that actually require thinking,” noted the unidentified respondent.
Martorelli stated limiting the turnover of monitors might require employers to exercise more discipline in pushing salaries higher and raiding competitors. Although that makes sense for all companies requiring monitors, another individual responding to the article notes that scenario is unlikely since private equity owners and private investors alike encourage companies to think more about growth than service. In other words, as long as CROs keep chasing new business opportunities, they will never stop overpaying for the monitors they need to attract and service that new business.
In the original article Martorelli also addressed the training needs of monitors, noting academic training programs are yielding monitors who are more thoroughly trained than any previous generation of workers. Unfortunately, many of these programs continue to be underutilized because of shortsighted thinking on the part of the companies hiring them. “Employers insist on sticking with a two-year experience requirement without adequately exploring the competency and value of recently credentialed monitors,” noted another reader.
Furthermore, while some surveys have suggested that soft skills such as communications, relationship management, conflict resolution, and time management are important attributes possessed by successful monitors, another comment received by Martorelli notes few training programs emphasize these skills. This leaves most monitors to learn the attributes on the job, provided they learn them at all.
ACRP Pushes Greater Competency
One group that provided some interesting feedback on the topic was the Association of Clinical Research Professionals (ACRP). According to Jim Kremidas, executive director for ACRP, the group is enhancing its long-standing efforts to promote and validate the competency of clinical research associates. Starting in January 2017, the certification and training programs offered by the affiliated Academy of Clinical Research Professionals will be harmonized with the core competency framework developed by the Joint Task Force for Clinical Trial Competency. Representatives from more than a dozen stakeholders have published a list of “competency domains” required by both new and experienced monitors. This is intended to increase the knowledge, skills, and abilities of CRAs.
According to Kremidas, as the need for 100 percent source document verification (SDV) declines, CROs are asking monitors to perform higher-order tasks. Fortunately, they are also offering them additional training to accomplish those tasks. He points to an article by Clara Heering, VP of Clinical Risk Management at ICON, which appeared in the April 2016 issue of Clinical Researcher. In it, Heering outlines her company’s use of The Human Factor Analysis and Classification System (HFACS) to consistently analyze unintended systematic errors. This has helped the company identify the cause of errors, such as failures in process or communication.
In the past, the focus would have been on retraining site personnel. The new approach with HFACS also calls for the monitor to associate the root causes of the errors with the most appropriate of human factors, grouped into different categories. Error-specific corrective and preventive actions could then be developed to assist the site with implementing new procedures to prevent recurring errors.
“Using this HFACS technique seems to be a tangible way that clinical researchers could adopt some risk-mitigation practices used effectively in other industries,” says Kremidas. “Ms. Heering and others note the aviation industry has been using HFACS to dramatically reduce the incidence of once vaguely understood ‘pilot errors’ and thereby halve the incidence of plane crashes in recent decades.”
ICH E6 Proposes Changes
Martorelli concludes the discussion by noting the evolving standards for clinical research included in ICH Efficacy Guideline E6 Good Clinical Practice (R2) Integrated Addendum (ICH E6), which was adopted in 1996. The ICH Steering Committee published a proposed update to that guidance in 2014. The intent was to harmonize ICH guidance with similar document published by the FDA and EMA. One concern was the tendency by some E6 followers to emphasize less important aspects of trials (such as focusing on the completeness and accuracy of every piece of data) at the expense of critical aspects (such as carefully managing risks to the integrity of key outcome data.)
Five important changes, noted in a recent Scrip article by Heering, are worth mentioning. First, RBM is endorsed, as sponsors are encouraged to adopt risk monitoring principles in a quality management system and in monitoring. Sponsors should also address significant non-compliance through the use of root cause analysis and prevention (such as the HFACS system).
A more explicit role for monitors is also suggested in the amendments. As the transition from paper to electronic records occurs, investigators have the explicit responsibility to ensure source data is attributable, legible, contemporaneous, original, accurate, and complete. Monitors will confirm compliance with the guidance.
Finally, investigators have responsibility for oversight of every task conducted at the site. And, sponsors should exercise more effective oversight of any trial-related duties carried out on their behalf. Both requirements present potential additional tasks for monitors.
Based on the current timetable, 20 members of the ICH E6 Expert Working Group will publish the final version of the updated Efficiency Guideline for Good Clinical Practice in November 2016.
For a complete copy of the mid-summer Pharmaceutical Outsourcing Monitor, please contact Michael Martorelli of Fairmount Partners at 610-260-6232 or by emailing Michael.email@example.com.