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Assessing CRO excellence and commitment to patient safety
Medelis: A number of well-publicized cases have revealed inadequate conditions and minimal oversight at phase I and II clinical trials being conducted by CROs. What criteria should medical officers apply in assessing CRO competency?
Dr. Gourzis: It’s important to identify a CRO that balances quality data monitoring with speed. If speed is emphasized at the expense of quality, it can be a set up for an expensive failure.
Whether a sponsor is using a CRO or conducting a trial with in-house CRAs, employee turnover will also directly impact the quality of the data gathered during a trial. Studies, especially phase IIIs, tend to last for at least two years. Cleanup and site closure often takes nearly as long as the trial itself. As patients complete their study period, study monitors must record, double-check and fill in the blanks in the data – all of which can add another year or two to the study.
Throughout this process, employee turnover – whether by attrition or promotion – can result in a lack of continuity of monitoring at each site, which adds to the potential for things slipping through the cracks.
Medelis: How does this employee turnover directly affect patient safety?
Dr. Gourzis: Much of the study data comes from patient questioning. When the medical monitor changes during the study, there is greater room for error due to subjective variability.
For instance, a monitor needs to evaluate whether a patient complaint is due to a disease state or the investigational drug. Site coordinators are very rigorous in questioning patients, but some may not be quite as thorough as others. The same is true for monitors.
If you have changes at the site, it’s hard to ensure data is real and correct. The ultimate responsibility rests with the investigator to make the final assessment. The CRO can only dig into the data so far.
Medelis: To sum up, ideally a CRO has minimal employee turnover, helping to ensure relatively consistent reporting. Any other qualifications a CMO should be looking for in a CRO as it pertains to patient safety?
Dr. Gourzis: A CMO should evaluate the CRO’s site experience, relationships and selection criteria. Just as a sponsor may select a CRO based on previous experience and relationships, a CRO will use similar criteria for selecting trial sites. And appropriate site selection and management is absolutely paramount to achieving the sponsor’s goals for the trial.
A CRO will have established relationships with sites and will continue to work together when the last trial has gone well. But the CRO must also step back and assess a site for each new trial. For example, at a particular time, the site staff may have changed or may be overcommitted with other trials, limiting the scope of the site’s staff activities. The CRO needs to have the relationships and controls to ensure that a sponsor’s study is conducted with experienced, appropriate sites.
Medelis: Sponsors lean heavily on CROs to get trials done quickly. If the CRO ultimately hires the investigator, and ‘the buck stops with the investigator,’ doesn’t that automatically put the CRO on the front-line to protect patient safety?
Dr. Gourzis: Like a lawyer during jury selection, the sponsor can pre-empt the CRO in an investigator recommendation. The CRO provides the short list of investigators and the sponsor makes the final selection. So the sponsor has the ultimate ‘yea or nay’ on an investigator, and thus the ultimate responsibility.
At the same time, though, the sponsor depends on the CRO to provide a list of highly qualified, experienced investigators with whom the CRO has direct experience or good rationale for recommending.
Medelis: What are the more progressive CROs doing to support or improve patient safety in this changing landscape?
Dr. Gourzis: Proper management of patient safety depends on effective communication between the CRO and the study site. The CRO can only report what is recorded and/or reported by the site.
Safety issues must be captured, recorded and communicated back to the sponsor, and it is essential to minimize turnover during these long, complex trials. So a progressive CRO will be very proactive in identifying good, diligent monitors and finding ways to keep them in engaged for continuity of service and consistency of quality. Much of the success of the monitoring visit has to do with the relationship of the monitor with the site staff and patients.
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