Put the Patient First In Clinical Trial Design

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Put the Patient First In Clinical Trial Design

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I like industry conferences to hear from industry leaders about their vision and where we all overlap. I recently spoke at the Medidata-Vanguard Executive Forum, and the topic of patient-centric trials came up again and again. My teams devotes enormous time and energy to improve the patient experience in clinical trials, so I was excited to hear that patient centricity is top of mind for life science executives today.

“How many of your colleagues can describe and visualize the actual patient experience? If pharma companies do not change the way we’re organized and the way we interface with patients, we’ll be on the backend of being able to innovate and help patient populations,” Cynthia Schwalm, a board member at G1 Therapeutics and the former CEO of Ipsen Biopharmaceuticals, said during a panel discussion on healthcare innovations.

“In the U.S., one of the biggest changes coming is technology that will strengthen patients’ ability be actively engaged in the decisions and outcomes of their healthcare,” she added.

Ms. Schwalm raises a great point. We see real innovation when patients come first, and when this drives every decision, including trial design.

“We should not only be polling doctors how a trial is going, we should be going directly to patients. If a trial is too onerous, we should be capturing that for future trial design,” a cancer R&D leader at a major pharma company said during the meeting.

Patient dropout rate for a clinical study today is often substantial, sometimes more than 30 percent. Factors of patient experience such as patient pain and anxiety are instrumental to a study’s success, and they must be considered during trial design.

Which is why I was thrilled we announced the launch of the Patient Burden Index (PBI) on the Medidata Cloud to empower sponsors and CROs to address patient retention challenges with the first data-driven, objective framework to patient-centric trial design.

Of course, new tools like this require a new mindset at your company too. A panelist used a nice analogy to describe how company leadership enables their companies for innovation: “In periods of strategic stability, corporate boards can make sure the sails on the boat of their company are in good shape. But the problem is that steamboats are coming from behind, and even if you buy a steamboat, will you know how to operate it?”

I like to think we provide the steamboat. And luckily, we have the industry’s best professional services team to help you use it.

[Download Using Patient Burden Evaluation to Improve Clinical Trial Planning and Execution to learn how to use an objective framework to quantify patient burden and improve protocol design and patient retention.]

About Author

Jackie Kent

SVP, Head of Product at Medidata Solutions