Quality management as a service
Many trials enrol slowly
Slowly enrolling trials usually cost more money in CRO time, may involve opening more sites at high cost, and delays may upset investors. Long dormant sites usually don’t achieve full potential.
Common trial issues
- There are many trials competing for few patients.
- The longer a trial takes to enroll, the more project time cost that is incurred.
- When a trial enrols slowly, a CRO may recommend more countries and sites, which is a costly option and can lead to just slower running sites
- A root cause is site feasibility assessment is often poorly conducted with the idea the CRO knows the sites – but even if they do: trial competition is fierce, site staff change.
- Risk-based monitoring means CRA face-to-face site staff contact is much reduced, and enrolment isn’t high on the list of tasks that a CRA has time to conduct.
- The usual approach to a dormant site of a CRA phone calling the SC and emailing the PI will usually not move a dormant site to enrol.
- It’s harder to motivate a site to start that has been dormant for a long time and lost patients aren’t gained later: sites usually don’t catch up.
Common site constraints
- Patient numbers by sites are guesses as there is a lack of site-specific databases, and they know with a high number will mean inclusion in a trial but from a poor guess many issues arise in expectations.
- The volume of trials in any usual Clinical Dept. means strong competition for site staff resources.
- Site issues may not be picked up during the usual site feasibility process.
- With rushed initiation visits, site staff may be left with lack of understanding of eligibility criteria, and how they relate to actual patients.
- Trials may have screening and other procedures that do not reflect the daily realities of the clinic and these can surface after initiation.
Patients face challenges
- Patient centricity is difficult to execute with the sponsor needs.
- Busy clinics mean patients may not have an effective discussion about a clinical trial as a treatment option: they want to feel the doctor’s support for the trial.
- Allied to this, patients and relatives often have concerns about being in clinical trials, especially a deep fear of receiving placebo and lack of understanding of placebo combined with standard of care.
- In much of Western Europe many feel usual care is enough to not need to risk a placebo.
- When the trial is running, reimbursement of patient expenses can be slow and so discouraging and leading to increasing drop outs.
What Gaea Does
- The CRO’s CRA to manage the site: the Gaea task is usually enrolment, but may be, for example, imaging delays.
- An experienced national Gaea Clinical Enrolment Manager (CTEM), trained in the trial, under the aegis of the PI, will meet site staff and conduct an initial deep dive analysis of the status and issues.
- If agreed with the sponsor, in the same initial visit the Gaea CTEM will have assisted site staff to find patients, which in many trials exist in medical records, and we define a site action plan listing the issues and responsibilities to address. We report this to the sponsor.
- Further visits focus on executing the site plan.
- It’s more cost-effective if the CTM can be active early in the trial, in education and ensuring readiness rather than only in the rescue of often long-term dormant sites, as some are always lost.