The clinical research industry today is undergoing a major makeover. Companies are continuously trying to look to adopt and implement effective and innovative ways to accelerate novel drug launches in the market. Clinical trials organizations today are more open and does not view patients as mere “subjects” to generate data, but as informed collaborators whose participation is very significant to the overall success of clinical trials leading to the emergence of the concept of “patient-centric trials.” Clinical trail patient management is becoming an important task.
Most clinical studies use a 'Site-centric' approach for Trial Patient recruitment. Although this seems to work pretty well for the more common disease categories like diabetes or high blood pressure, it has reached its limitations for the rare disease categories.
Using various pathways, Sites are identified that are supposed to be able to enroll an adequate number of trial subjects. Then a time- and money consuming process is began to qualify each clinical site. It is typical for the complete regulatory review and qualification process to take months. And does this always pay off? No. In some studies, up to about 20% of the ‘enlisted’ sites fail to deliver a single patient. With the number of sites not being able to supply the expected number of Patients being even higher. Patient recruitment issues has been ranked as one of the major causes for trial delays.
A patient-centric approach begins with finding the right patient for a clinical trial. A possible method for finding a suitable trial patient is by using Google Adwords to reach potential Trial Subjects. If a qualified patient is found, the patient might be directed to one of the current qualified sites or and this is a new avenue, a new site is opened.
The first option, routing a patient to an existing Study Site, is very standard and does not require many adjustments to Site approval process. In fact, the only requirement is that one has ones Sites ‘in place’ before starting recruitment of patients.
The second option is a novel approach to Patient recruitment and requires a re-design of current work-flow and business processes. It expects a system is in place which allows Sites to be reviewed and qualified in a much shorter time-frame, might be 2 weeks as maximum. Another implication might be that you might have only a single patient at a Site, the Site qualification process will need to be as cost-effective as possible. Moving from the current paper-based, sending documents back-and-forth, approach to a more online approach, will be among the steps which have to be taken.
So which approach is the best?
Well there is no best method in this. It is clear that the Site-centric approach has proven its value many times over time. But if we take oncology as an example, the trend is that cancer treatments become much more personalized, making the patient recruitment process more challenging. If you are looking to recruit patients with some rare condition, starting with finding those patients and then finding treatment centers within reach of the patient, might that be a more optimal pathway. Compared to qualifying treatment centers first and then wait until a proper candidate appears. It is clear that this redesign of the recruitment process might bring value to everybody in the process. More patients with the rare condition will be chosen if they want to participate in the trial.
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