From The Editor | August 2, 2022

Sites And Patients Need Help – Here's What You Can Do

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

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Ian Wyglendowski is passionate about being a better partner for patients, sites, and CROs. He is currently the head of strategic clinical partnering at UCB and is focused on partnering activities that will create better relationships between all stakeholders in the conduct of clinical trials. In a prior article, Wyglendowski discussed ways to create a better relationship with CRO partners. In this piece, he discusses what sponsors can do to better accommodate and assist sites and patients.

Understand Their Needs

If you want to be a better sponsor company for the patients taking part in your trial, you should strive to be as accommodating to them as possible. That means learning what they are hoping to get out of the trial, what they are willing and not willing to do, and then adhering to their preferences as much as possible. Wyglendowski notes this can best be accomplished by meeting with patients living with the disease you are going to treat. Surveys conducted before or after a trial can also provide valuable insights. Speaking to patient advocacy groups can also yield valuable information. Although there are companies that do all three things, he recommends giving this some thought, deciding on the best method for your company, and then sticking to it. 

“At UCB, we first ask ourselves if this is a therapeutic area that we should be involved in,” he states. “If it is, we then determine what end points are important to our patients. Have patients provide insights about the strategy of a study before you even write the protocol. The feedback can even deal with things like drug delivery. For example, explain the different devices that can be used for an injection and let the patients tell you if one would be easier to manage than another. It would also help to know if the treatment will be administered by the patient or a caregiver.”

Since sponsors are not supposed to know the patients in a study, that can create difficulties in gathering feedback. UCB has worked with a variety of different vendors that have helped the company build patient surveys. Those companies can now survey patients after they have been enrolled in a study to ask about the experience and what could have been done better or improved. UCB receives that data in real time, instead of finding out later that a certain procedure was burdensome for patients.

UCB also calculates a net promoter score (NPS) for all its studies to measure how it is scoring with patients over time. This helps the company understand patient burden, which it can account for every time it designs a study. Every assessment is now analyzed to determine if it is core to the study.

“Patients generally have their choice of trials,” says Wyglendowski. “That means we need to make our study attractive and provide patients with options.” 

Find Ways To Help Your Sites

Ian Wyglendowski, head of strategic clinical partnering, UCB
Clinical sites are the final piece of any sponsor of choice initiative. The most important thing a sponsor can do for its sites is make sure they are paid in a timely manner. At UCB, Wyglendowski leads the group responsible for site contracting and establishing the global budget template. He notes regional differences between the U.S. and other countries can complicate the payment issue.

For example, what triggers a site payment in the U.S. is different than what happens in other countries. In the U.S., sites can be paid on demand, whereas in other countries the site is required to send an invoice to the sponsor before they can be paid. 

Wyglendowski believes the payment issue has improved with new tools available. Electronic data capture (EDC) has helped. Online data platforms can now be connected to site payments. When a site enters required data, that data is monitored. When the monitor checks a box in the EDC system noting a review is complete, the action can trigger a payment.

While UCB believes it is important for sites to be paid in a timely fashion, the company also wants to ensure tasks are completed by set deadlines. UCB has created KPIs around site deliverables. There are timeframes by which certain actions need to be completed. If timeframes are not met, penalties can also be applied.  

Connect With Site Personnel

Wyglendowski believes it is a mistake to turn the site relationship completely over to the CRO. He notes that sponsor companies need to be engaged with sites early and for a long duration. UCB is calling and meeting with sites, even as the CRO is working behind the scenes. That interaction involves speaking to PIs and other staff at the sites to hear their concerns. UCB is also a point of escalation for sites when issues arise with the CRO.

“I feel for the sites,” he says. “What they have been going through the last few years has not been easy. While it is important to have a presence at the sites, you want to be careful not to overwhelm them, especially when they are under resourced. If a site is busy and understaffed, you are not doing them a favor by showing up with five people to discuss your study. Sponsors should try to have a presence but not be overwhelming.” 

There are ways for sponsors to help sites, especially during tough times. Wyglendowski cites three examples. First, he believes in incorporating concierge support into trials. Sites can recruit patients into studies, but for many of them getting to the site can be a challenge. Sponsors can help by arranging flights or hotel stays, thereby taking that burden off the sites and patients. He believes offering travel and lodging help early in your feasibility campaign can have an enormous impact in some populations. Direct payments to patients can also impact recruitment and retention. 

Telehealth And Home Visits Create Issues

A second example has to do with the pandemic and the increased use of telehealth. That technology was expected to help sites, since many would not have to host patients on site. For patients, the risk of exposure to COVID was also reduced. Although the idea sounded good, UCB found there was a huge burden around validating the system being used. For example, if the Zoom platform was being used for telehealth visits, UCB found there were vulnerabilities around security. Although telehealth was supposed to assist with Clinical Research Associate (CRA) monitoring and patient visits, sites faced added burden around showing validation documents for the technology.

The third example is the rise of home health services, such as nurses and phlebotomists. From the beginning of the pandemic, this sounded like a great idea as it would allow patients to participate in clinical trials from their home. While this was a benefit for many, others who had a close relationship with their investigator preferred to see them in person. Others simply preferred to not allow strangers in their homes.

“Patients don't know who these people are,” says Wyglendowski. “They are not affiliated with the site and the site does not have oversight of them. That also created liability issues and some of the larger centers raised concerns over insurance coverage. Some simply told us they did not want home health services and did not want vendor employees touching their patients. There were also hurdles around the technology used with home health agencies. We took a couple steps back, reflected on those concerns, and tried to take a more flexible approach.”