PhESi is a data-driven solution provider serving clinical development organizations around the world in the following areas:
- Select best investigator sites: Proven to deliver superior enrollment results
- Assess clinical trial feasibility: Reliably identify the potential challenges for clinical trials in planning, and allow our clients to proactively take action to mitigate risk
- Process improvement support: Quantify opportunities potentially can be improved, recommend actions to realize the opportunities, measure the impact from implementation, and reward the people who contributed to the achievement
Site Selection Services
Investigator site performance is one of the most important perennial challenges
facing clinical trial execution teams across the industry. The inability to enroll
the needed number of subjects in a targeted timeframe strains study budgets
and resources, and prolongs cycle times.
PhESi performance based site selection has been helping our clients to deliver
superior enrollment results in more than 100 clinical trials, and the number of
trials continues to grow rapidly.
Moreover, PhESi recommended sites, as expected, have also resulted in
decreased dropout, reduced query rate, and other improved quality measures.
Clinical Trial Feasibility Accessment
When we encounter challenges in conducting clinical trials, the first thing we
can measure is that the sites are not enrolling as we expected. So we blame site
performance. That blame is intensified by the fact that there are still a few sites
seem to do well in enrolling. Factually, there are more than just site enrolment
performance can potentially derail a clinical trial.
- Adequate number of sites: People usually understand that too few sites will
end up with prolonged enrollment cycle time. So when we add more sites to
contribute to enrollment, we should be able to shorten enrollment cycle time. But
that incremental benefit diminishes quickly when we add sites beyond certain
point: Sometimes too many sites also prolong enrollment cycle time, along with
significantly increased costs.
- Process limitation: Conventional wisdom tells us that we can activate more sites
if we add more resources. We examined site activation curves from more than 1,000
interventional clinical trials with 10 or more sites per trial in a single company. 6% of
the trials were able to activate 50 or more sites in 100 days. When we focus on the
pool of trials with 50 or more sites, 20% of the trials were able to activate 50 or more
sites. Unfortunately, we cannot extrapolate this relationship: It plateaus around 25%
to 27%. In another words, we do not have the freedom to manage a trial with large number
of sites without significantly compromising the enrollment capability from
individual investigator sites involved.
- Inclusion/exclusion criteria: A company ran two pivotal Phase III multiple
sclerosis trials side by side, with one key difference: one trial targeted both men and
women, another trial enrolled only women. Given MS patients have a composition of
75% women and 25% men, you may have not expected that the women only trials
took twice as much time to finish enrollment (1,073 days vs. 561 days). The process
adjusted enrollment rate was merely 0.33 patients per site per month, compared to
1.41 patients per site per month for the trial included both men and women.
This impact also universally exists among the disease indications we have analyzed.
The reduced pool of available patients often has far more overarching impact than a
simple proportion of math can measure!
Armed with a database of more than 300,000 clinical trials and an integrated
approach, PhESi clinical trial feasibility assessments provide answers to the following
- Where to place the trial
- What sites to use
- How many sites needed
- What is a realistic expectation to the site activation process
- What are the impact of protocol design to operational deliverables
- What are the potential risks and what actions can be taken to mitigate the risks
- What will be the enrollment cycle time and what can be done to shorten it
We also answer questions important to you and your management. You can expect the following benefits from our services:
- Improved and quantifiable operational deliverable including:
- Shortened enrollment cycle time
- Reduced financial costs
- Better defined responsibility and accountability of involved functional teams,
so that they can be more appropriately rewarded by what they have achieved
- More effective communication among stakeholders