3 Steps To Patient Centric Clinical Trials

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Centering the drug development process around patients is still a struggle, as evidenced by declining clinical trial recruitment stats. However, Kelly Franchetti, executive director of global patient insights and engagement for Mapi Group, had one big recommendation for pharma at the 2015 Patients As Partners in Clinical Trials conference. According to Franchetti, one of the best ways for pharma to see clinical trials through a patient-centric lens is for those running the clinical trials to recognize themselves, too, as patients.

“All of you are patients; you all either have been, are going to be, or will be patients. But I doubt if I were to ask ‘Who are you?’ I doubt someone would say I am an oncology patient; I am a psoriasis patient.”

Traditionally, pharma has approached the patient’s physician to establish what is best for the patient and the treatment of the disease when establishing a trial’s protocol. Franchetti agrees that a doctor’s input is absolutely necessary when establishing inclusion and exclusion criteria and other elements of a clinical trial’s protocol. However, in doing so, pharma “is not really realizing what’s going on with this patient.” Franchetti adds, “We need to step outside of that box and realize that [doctors] are removed from this patient. It’s very much a professional relationship. They can’t tell us what the burden of disease is. They don’t have the time to really get to know these patients, to know what the life-mapping looks like.”

Step 1: Conduct Qualitative Research

To get a better handle on who patients are outside of the clinic and who/what influences their decisions, Franchetti argues in favor of a dual approach for research. While a quantitative study will help determine protocol, attitude, and behavior of a large audience in a certain disease space, Franchetti pushes for qualitative research before all else. Getting to know a smaller sample size of patients is key for pharma to determine what would make the clinical trial experience more valuable to each person. In doing so, pharma would be better able to create the most effective messaging and protocol to draw patients to the trial.  

At the same time, this process would give pharma insight into each patient’s “ecosystem” and help trial developers understand the biggest influences on each person’s decisions. After all, said Franchetti, patients “are not making their decisions in bubbles. A majority of decisions about healthcare or being involved in a study are being held at the family table, which means everyone has input there. We want to research and find out what that input is.”

Franchetti posed several important questions pharma should be asking of their qualitative research group, including:

• What are patients’ attitudes toward clinical trials, their medications, and towards pharma?
• Do patients and/or their influencers believe everything healthcare providers are saying?
• What will motivate and resonate with them? Is there anything pharma can give to a trial participant that will add value to participation?
• What online resources are patients using? Are they relying on blogs and websites for their information?

While pharma as a whole is still skittish about the use of social media, these platforms and the Internet in general are serving as one of the foremost influences in urging patients to take control of their own healthcare. Because of this, Franchetti says pharma should be paying close attention to a prospective patients’ Internet habits — especially the blogs they are reading. In healthcare, doctors are considered to be key opinion leaders (KOLs). However, to patients, Franchetti says, “a KOL is the one blogging. In the rare disease space in particular, there are really strong opinion leaders talking about what trials are coming up, what drugs are coming out, and which doctors patients should talk to. You want to know who that is in that therapeutic area, because that’s where you’re going to get the insights into what that patient population needs from you.”

Step 2: Partner With Advocacy Groups

“Advocacy holds the keys to the kingdom. Advocacy groups know about their patients inside and out,” says Franchetti.  However, when it comes to pharma and advocacy working together, the partnership should provide mutual benefits to both parties involved. Advocacy groups can provide feedback on how appropriate a trial’s protocol might be, while pharma can return the favor by helping with other business practices the group might not have the bandwidth to carry out (e.g. providing marketing or financial advice).

Step 3: Determine Best Communication Methods

Thanks to the numerous social media platforms and technologies available today, there are a number of ways pharma can communicate with prospective patients. However, the choice of the best method to reach this population depends on the research carried out and the questions asked. For example, pharma should ask questions such as, would creating an app be appropriate? Should this be a direct-to-patient program that involves a call center? Would a newsletter be the best way to reach patients?

Franchetti spoke in particular about the value of a newsletter — but just as pharma needs to start addressing patients as people, what we’ve come to associate as a typical medical newsletter also needs to undergo a transformation. Newsletters have often focused on the technicalities behind the disease process, the study, or the medications for the condition. However, following discussions with a group of prostate cancer participants, Franchetti learned that this kind of information was less valuable than a newsletter that provided them with information on how to approach their boss at work about their condition or how to deal with sexual dysfunction.

Regardless of the method used to communicate with patients, Franchetti argues that to truly embrace patient centricity, pharma needs to focus less on the trial or the disease process and more on quality of life. When it comes down to it, the patient is more than the indication; they are a mother, a husband, a son, or a grandparent, and they have daily responsibilities to attend to. “Pharma needs to take a step back and realize that its patients are people,” says Franchetti. “You need to speak to them as people, and the only way you can do that is by doing this in-depth patient research.”