CROs, Sponsors recognize need for improvement, opportunities

By Melissa Fassbender contact

- Last updated on GMT

While the industry has several occasions for optimization, the challenges it needs to address “are as multifold as the opportunities.” (Image: iStock/Weedezign)
While the industry has several occasions for optimization, the challenges it needs to address “are as multifold as the opportunities.” (Image: iStock/Weedezign)

Related tags: Better

According a recent survey, while there is a disconnect between Sponsors and Providers in some areas, the industry as a whole agrees that there is room for improvement.

According to the 2016 Avoca Quality Consortium (AQC) Member survey, the disconnect exists between Sponsor satisfaction with what they receive from Providers, as it pertains to quality, value, and overall work, and Providers’ satisfaction with what they deliver.

However, Sponsors and Providers were well aligned when it comes to perceptions of where the industry shows strength in incorporating patient-centric thinking into clinical trials.

Dennis Salotti, VP, Operations, ​The Avoca Group, told us one of the most surprising results of the survey was the level of alignment between Sponsors and CROs on levels of confidence in trial design, oversight, reporting, and patient compliance attributes. “In aggregate, they agree where they are confident and where they might need to improve​,” Salotti told us.

The surprising thing is that they both similarly rate themselves higher than their partner when assessing performance with respect to patient-centric trial design and execution​,” he added.

Salotti explained that this perception gap between Sponsor and CROs in this area exists reciprocally, and may be a potential collaboration barrier.

Ultimately, according to the survey findings, “it is apparent that the industry as a whole recognizes they need to do a better job​,” said Salotti – and it has identified a few key areas where immediate opportunities exist, such as returning results back to patients, simplifying consent forms/process etc.

These topics were also noted​ as opportunities at the fifth annual AQC Summit USA and the inaugural AQC Summit Europe.

Opportunities for optimization

The opportunities for improvement fall into a couple major categories, Denise Calprice, PhD, Senior Consultant, The Avoca Group, told us.

From an experimental design point of view, Calprice said “we have the opportunity to move trials in the direction of answering questions that are more meaningful to patients in terms of the impacts of their diseases and treatments on their lives​.”

Additionally, from an operational point of view, “we can design trials to offer a better overall patient experience, presumably with the accompanying benefits to industry of improved recruitment, retention, and compliance​,” she added.

Within these categories Calprice said there are many specific opportunities, as the patient perspective has historically been under-addressed.

Notably, as Calprice explained, all of these opportunities require direct communication with patients about what’s most important to them, “in some manner and at some level​.”

A muddy concept

Concurrently, while the industry has several occasions for optimization, the challenges it needs to address “are as multifold as the opportunities​,” said Calprice.

Most fundamentally, “the patient perspective​” itself is “a muddy concept​,” said Calprice – as patients’ perspectives are as varied as people and perspectives in general.

So how does the industry come to an understanding of what priorities and perspectives are fairly general to patients, and in what areas we need to gain a better understanding of patient subsets with different perspectives?

This is an area where we need to be very cautious not to pursue a ‘one size fits all’ model across the wide variety of conditions that we study, as tempting as that might be​,” Calprice said.

With a goal understood, Calprice explained that challenges remain along the “how to​” continuum, “from knowing how to make sure that we connect with the full spectrum of patients we need to hear from, to knowing the right questions to ask, to interpreting and acting upon the information that we receive​,” she said.

This is not to mention the challenge of resources and keeping pace as treatments change and improve over time. “Everything we know will change, as patients come to take some things for granted (e.g. minimal side effects) and start to worry more about new things (e.g. cost)​,” added Calprice.

However, “these challenges are all surmountable​,” she said, “and one of the exciting things about overcoming them is that the pay-offs are both so tangible and so human​.”

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