From The Editor | June 16, 2016

With Aspire, BMS Puts Focus On Clinical Sites And Patients

Ed Miseta

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

With Aspire, BMS Puts Focus On Clinical Sites And Patients

Patient and site relationships are a primary concern to pharma and bio companies. The desire to be a sponsor of choice to both groups, as well as CRO partners, is suddenly a hot trend in the industry. Bristol-Myers Squibb saw both of these trends coming years ago, and has been taking steps to improve those relationships. It was one of the first companies to put a diversity and patient engagement team in place, and the company’s Aspire program, put in place more than a year ago, is attempting to bring BMS even closer to patients, while improving site relationships, operational analytics, and the value of data collected.  

In this Q&A article, Peter Ronco, VP of Global Clinical Operations at BMS, discusses some aspects of the program, and why pharma needs to embrace the principles in it if we are serious about bringing down the cost of trials while improving the patient experience.

Ed Miseta: It’s nice to see the entire industry putting a greater focus on patients, and recognizing the difficult decision they make when electing to participate in a clinical trial. Are we gaining a better understanding of the patient experience?

Peter Ronco: I think everyone who works in the life sciences industry really needs to understand what it means to be part of a clinical trial. I had a loved one who participated in a clinical trial. I was only able to view the experience from the outside, but I know it was an incredibly difficult moment in that person’s life. How we are able to support these individuals throughout that process was really the foundation for this framework.

When an individual is told they have just been diagnosed with a disease, especially cancer, it’s one of the worst days of their life. Oftentimes they are also told that current treatments on the market are not great. At that point, they are full of questions. How do I find information on the available outcomes? How do I educate myself on this condition? How do I understand the science around it? It can be a very scary and confusing time.

Of course once they’re actually in the study, it doesn’t necessarily get any easier. Clinical trials can oftentimes be an additional burden beyond the daily hurdles of living with a specific disease. Patients have to get on a very rigorous schedule with appointments that are not generally scheduled around their activities. They might need to come in every week or every two weeks based upon the specific criteria of the study or undergo additional tests and procedures.

Miseta: There are new technologies hitting the market that promise to create a better trial experience for patients. Do you see traction being made within BMS to incorporate these newer technologies?

Ronco: I do. I think there are some exciting technologies emerging around wearables and how we connect with electronic medical records. The piece that I think has the greatest potential to improve the patient experience in the short term is electronic consent (eConsent). It will allow us to use technology to help patients better understand what they are consenting to.  

To understand the benefits of eConsent, think about how we used to perform the consent process. A physician is sitting front of a patient, telling them that they’ve run out of options for their particular tumor. Then you put a 25-page, very technically written document in front of them and say “please sign this, we have a list of adverse events.”

When you look at it that way, the consent process itself is fundamentally flawed. eConsent will provide us with opportunities that go much further than taking a document and sticking it on an iPad, which provides almost zero additional benefit. eConsent will help us to educate patients at one of the most difficult moments of their lives. They will learn about both the risks and benefits, and what it means to be going through a trial.  

BMS is currently doing a number of pilots in that area right now. In the end it will make patients feel like they are engaged in the process from the very beginning, and not someone being subjected to a long and technical legal document that they don’t understand.

Miseta: One of the major components of the Aspire program is creating better relationships with sites. What are you doing in that area?

Ronco: Site relationships are critical because they are the conduit that exists between the sponsor and the patient. We continue to invest in our site-facing people as we believe that provides us a competitive advantage.   We have site monitors that have developed close and long-term relationships with sites, and that effort is paying off. When I walk into a site for a scheduled visit, nothing makes me happier than seeing a nurse or study investigator give the site manager a hug because they have been working together for 5 or 10 years.  They have a trusting relationship and that tells me we are doing what it takes to become a preferred sponsor.

Miseta: In many companies that site relationship still seems to be in the hands of the CRO. Will this be a new trend moving forward?

Ronco:  Although we have a large internal group that interacts with sites, almost all pharma companies including BMS, partner with CROs to deliver at least part of their pipeline.. So CROs certainly have a key role to play in this process, but we also see the benefit of maintaining a relationship with the sites. We have solicited a lot of feedback from sites and one of the things they make clear is that they want a long-term relationship with BMS that they can build on over the years and not just a transactional vendor relationship.

Miseta: When working with a CRO, can involvement by that extra layer of personnel sometimes complicate the relationship?

Ronco:  It would complicate things only to the extent that that there are more people engaging with us and the sites. Having said that, we do try to work with a core set of trusted CRO partners and have had extensive conversations with those CROs about the site and patient experience we are trying to deliver. There are many aspects to those conversations, including the tools that are used, the standards that are followed, the way we prefer to interact with sites, and partnering with some of our field medical personnel to perform site initiation visits. This involves taking the work a CRO is doing on our behalf and complementing it with our own skills and experience. We believe this is the best way to create a positive experience for the sites.

Miseta: The managers and scientists who generally design protocols are sometimes not the best individuals to have working with sites and patients. Was any effort made to recruit people who might be better at interacting with those groups?

Ronco: The short answer is yes. Lori (Lori Abrams, director, diversity & patient engagement at BMS) and her team are an absolutely essential part of this program. We are making a large investment in advocacy activities, and it is important for us to be surrounded by people who are passionate about helping and working with patients. Connecting patients to what we do every single day is our number one priority, and is what patient centricity is all about.

But having said that, I think it’s also important for the entire organization to have much more of an external mindset. I have called on my entire leadership team to go out and participate in site visits and investigative meetings. I encourage them to meet with sites, patients, and advocacy groups so they can continue to understand the changing landscape. Many of the employees in Big Pharma companies have worked in Big Pharma for 25 years or more. We need to occasionally get out of the office and see what’s happening with patients and with sites, to make sure we understand their problems and concerns. Bringing more patients, site personnel, and care givers into our company to meet with employees has also been a focus for us. We need to engage with patients on an ongoing, repeated, and long-term basis.

Miseta: A diagnosis of cancer can be devastating for a patient. Do certain diseases require a closer interaction with patients and caregivers?

Ronco:  At BMS our portfolio has evolved to where we really only work on specialty medicines that treat serious and life-threatening diseases. Oncology is certainly a great example of that but there are others as well. In these rare disease areas, patients have not typically received the same level of attention as patients with more common diseases. They have also not had much of a voice in the advocacy community. We are really trying to change that situation.  

If we look at just the oncology space, the rise in the complexity of tumors and their treatments is changing the game. It is also changing how we partner with patients, and the industry is trying hard to work through that. It’s very different than if you were doing large vaccine study or a large primary care studies. Those are important as well, but they’re not as critical as these types of specialty diseases.

Miseta: Does someone in your position get to spend much time interacting with patients?

Ronco: Absolutely. I think you have to. Obviously as part of my job I get to meet with many of the sites, but that’s more in an official capacity. Those discussions revolve around how we are working together and what we can do to improve the relationship. That’s really important. But I’ve also had the opportunity to visit sites as an undercover boss. This has given me the opportunity to meet with patients sitting in waiting rooms and hear their stories, their hopes, and why they are participating in trials.

Each one of those stories is incredibly inspirational. One of the reasons I do that is to have those insights to take back to the company and share with others. I can also share them at town halls and small group meetings as well, to continually remind people what it means to be a patient and participate in a clinical trial.