January 9, 2019 | You know that having the patient perspective in clinical trials is important. You agree that involving patients is both good business and good science. You want to start including the patient voice early in the trial design process.

But what is step one?

Beth Zaharoff, director of patient-focused clinical trial engagement at TESARO, believes it’s about bringing senior management on board, cultivating relationships with patient advocacy groups, and keeping the business objectives in mind.

Zaharoff and several of her colleagues will be hosting a roundtable discussion on starting from scratch to get patient input into clinical trial design at the upcoming Summit for Clinical Ops Executives, SCOPE, in Orlando, February 18-21.

To get the conversation started, Zaharoff talked with Clinical Informatics News about what comes first.

Clinical Informatics News: When planning to bring patients into trial design, how do you address objections from senior leadership?

Beth Zaharoff: When building a patient centric culture that includes asking for input from lay people into the design of a clinical trial, it is crucial to have the support of senior leadership. After all, the culture of a company trickles down from the top and if the senior leaders talk the talk, it is easier for the “rank and file” to walk the walk. In case this is a challenge and support for activities in this area is lacking, there are several things to point out that could potentially turn the tide. Most importantly, look at the company values and mission. Many companies say that they put patients at the center of everything they do. But how many who say it, actually walk that talk? Also of significant importance is money. By getting input from people who know what it’s like to live with a disease, we can theoretically save money on amendments and increase enrollment and retention. And to put an even finer point on it, the FDA has Patient Focused Drug Development in its’ sights, and guidelines for industry are currently being developed.

How do you begin to partner with advocacy organizations to obtain patient input?

Advocacy organizations exist to support and educate, and their constituents are very loyal and invested in the work that they do. Building a strong relationship with these organizations based on trust, mutual respect and a shared vision is good for business—for both advocacy organizations and industry. Not only are advocacy organizations made up of people who know what the patient experience is like, their constituency is made up of “experts” in a particular disease. These experts, who are the people who know what it’s like to live with the disease, are the ones who can spot burdensome aspects of a protocol that might limit participation. Advocacy organizations can reach out to their constituents to find those who are willing to lend their voice to industry.

How do you stay mindful of trial timelines while getting input from patients?

Clinical trials are developed around strict timelines and working within those timelines can be one of the biggest challenges when planning to get patient input. The key lies in early involvement in the protocol development process. Being aware of timelines as early as possible increases the likelihood that patient input can be solicited, reviewed, and protocol modifications made all in a timely manner so as not to delay the process.