Case Study Three

Comparison of Patient-first (Just-In-Time) versus a Traditional Enrollment Model in a Phase II Lymphoma study.

Synopsis:

Pharmatech Oncology’s Just-In-Time enrollment methodology increases enrollment by 63% while mitigating financial risk for sponsors when directly compared to a non-specialized global CRO.

Case Study:

Background: A global biotech company contracted with Pharmatech Oncology for research site identification and enrollment support services 60 days after contracting with a non-specialized global CRO in order to test Pharmatech’s enrollment efficiency claims in a direct comparison. This ongoing study is the sponsor’s first attempt to utilize Pharmatech’s Just-In-Time enrollment methodology.

Just-in-Time System: Just-In-Time (JIT) modifies the traditional project management methodology for enrolling patients in a clinical trial. Instead of opening sites and waiting for patients to present, JIT utilizes a large group of research ready sites to identify appropriate and interested patients within usual care. Then research centers are initiated for immediate, prequalified enrollment opportunities. The traditional enrollment process is flipped, from a site centered to a patient first approach. For JIT to function, the site must be able to use a central IRB (Pharmatech has all the essentials documents for the project) and the sponsor must be prepared to open and train the site within 10 business days from patient prequalification.

A large number of Pharmatech Oncology Research Network sites enter a “pre-identification” stage without incurring the cost of opening and maintaining the site. Once a patient is identified, IRB approval is obtained – a process which requires on average only 2 business days, then and the site is opened and patients are dosed. Therefore, every open site has a high probability of immediate enrollment, which reduces the risk, time and costs associated with non-enrolling or slow- enrolling sites. On average 25-30% of all traditionally managed sites never accrue a single patient and are subsequently closed.

Results: After 11 months of open enrollment, the competing CRO’s 24 traditional sites accrued 6 patients from 4 sites, leaving 20 sites that have yet to accrue a single patient. Most likely, 14 of the 20 non-enrolling sites will eventually enroll a patient, leaving 6 (25%) sites that will likely close without accruing. After 9 months, Pharmatech has enrolled 8 patients and has opened 8 Just-In-Time sites.

In direct comparison, Just-In-Time has provided a 63% increase in patient enrollment efficiency against the global CRO when comparing patients-per-month and a 389% increase in patients/site/month enrollment efficiency when the number of sites needed to enroll is considered.

For this clinical trial, the direct sponsor cost for a single cycle of test article is $3,500. Upon opening a study site, 6 cycles worth of drug is automatically shipped directly to the site. If 6 traditional sites do not accrue a single patient, the sponsor will incur the cost of opening 6 sites (approximately $90,000) plus the drug costs of $126,000 ($3,500 x 6 cycles x 6 sites) which will need to be destroyed. Therefore, Just-in-Time will most likely mitigate approximately $216,000 in direct sponsor costs because of non-accruing sites.

Discussion: The above comparison does not factor in the macro costs related to study efficiency. Just-In-Time improves patient enrollment efficiency, thus reducing the overall speed and cost of clinical trial completion. This added efficiency stands to reduce product development cost and time to market, and provide for a longer patent-protected earning period. For earlier stage biotech companies, enrollment efficiency reduces annual burn rate and may help expedite product milestone requirements. Each of these factors can amount to several millions of dollars per year for biotech and pharmaceutical companies.

Conclusion: In a capital-sensitive time period, companies must reduce costs and improve clinical trial enrollment efficiency in order to mitigate risk and cost of a given study. Just-In-Time provides a solution for oncology trials which addresses these needs for cancer focused companies.