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Innovative clinical trial design

By AmerisourceBergen

Leveraging new tools to maximize clinical research opportunities

Black female nurse uses stethoscope on older Black female patient
Biopharma companies understand bringing products to market relies on clinical trials. Yet, disparities in clinical research populations and poor protocol design can have negative consequences. Working with a partner with deep relationships with the physician practice community and deep understanding of how to use data can set biopharma companies towards a path of improving their recruitment and study design, leading to more patients benefitting from the life-saving therapies they develop.


Enrollment and design challenges

Clinical trials, by and large, are not an accurate representation of all the potential patients who could benefit from a product. Studies lack diversity among enrollees, with recruitment results often worse than targets.

In the traditional model of identifying patients, clinicians must manually review records to see who meets a study's criteria, a time-intensive process. And that's just when either a practice is a clinical trial site or an awareness by clinical research staff, including physician investigators, a particular trial exists. Research has shown only 15 percent of patients are aware of clinical trials for their diagnosis.1

One possible explanation for under-enrollment in protocol(s) may be related to tightly defined inclusion/exclusion criteria for the desired patient population. This results in a narrow patient sample often difficult to identify in clinical practice. The communication between the clinical research sites and the biopharma companies around how to operationalize the protocols in place is inconsistent, leading to incomplete understanding of potential challenges in study execution.

Additionally, any change between the creation of the protocol and the enrollment of the first patient causes a delay in getting the trial launched. For recruiting success, biopharma companies need to engage with research sites earlier in the protocol development process.

“We think we are in a unique position to be a great partner to help with these challenges. With our AdvanceIQ research network, comprised of community -based specialty practices, expertise supporting an extensive warehouse of clinical data, and clinical domain expertise we can work with you to address some of the challenges of clinical research," says Susan Weidner, senior vice president, IntrinsiQ Specialty Solutions.

Trial design capabilities

One challenge that a commercialization partner can help solve for biopharma companies is the identification of the optimal site for their trial, along with the identification of the right patients once that site has been appointed.

There has been a growth in “just-in-time" clinical trials, with reduced screening times, that are set up in 10 days or less. Remote monitoring is also gaining traction as a way to overcome certain patient participation challenges.

With these new developments in trial design and execution approaches, it's even more crucial to work with a partner with global reach beyond traditional go-to-market activities. Relationships with sites of care can be an asset to biopharma companies launching a trial. So can a partner who has expertise in clinical trial enablement.

“Clinical Trial Navigator can make research results more robust and accessible by sourcing under-represented community patients," says Weidner. “We've seen different patient populations that manufacturers cannot find and they are reaching out to us asking, 'Where are they? Where can we find them?' And we're pushing them to those practices."

These new capabilities allow biopharma companies to translate inclusion criteria into a standardized format easily understood by providers. Connection to the right patient at the right time, including clinical trial eligible yet under-represented patients, makes research more accessible.

Biopharma companies can also rely on the partner's data to find potential clinical research sites, based on a practice's electronic medical records or profiles of investigators. Reducing the recruitment timelines by having the ability to search for sites and patients in an up-to-date database removes part of the enrollment burden on the site. The ability to analyze protocol inclusion and exclusion criteria and design will determine why patients may drop out of a study, so biopharma companies can adjust accordingly to lower attrition rates.

A commercialization partner can then act as a connector between the company and the site, leveraging its relationships on both sides of the equation. Finding that partner who understands the clinical development journey starting with R&D all the way through the regulatory and post-approval phases is key to unlocking product potential

1. Feller, S. One in four cancer trials fails to enroll enough participants. Health News. December 30, 2015.


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