Do Your Clinical Trial Participants Feel Like Valued Customers?

By Ed Miseta, Chief Editor, Clinical Leader

In case you missed it, car shopping site Edmunds.com released a survey in 2014 showing how averse customers are to going into a car dealership to purchase a new vehicle. The company found that one in two people would prefer to give up Facebook for a month, while one in three noted they would rather go the Department of Motor Vehicles or do their taxes. One in five Americans would rather say goodbye to sex for a month than negotiate the price of a car.

Going out to buy a new car should be a happy and pleasant experience, and yet many consumers clearly view it as a very unpleasant one. Part of the reason might be that loss of power or control that many feel when walking into a dealership. Or it may have to do with the general distaste many consumers experience when having to haggle with a salesperson. Either way, there is certainly a feeling that the salespeople are centered on themselves and the dealership rather than the customer.

Now replace the word customer with patient and think about how many of them feel about the pharma industry and clinical trials in particular. According to Roslyn F. Schneider MD, MSc, Global Patient Affairs Lead at Pfizer, patients can often have that same feeling of being powerless, and be left with the impression they are there to serve the drug development process, and not the other way around. Schneider made her remarks at the 2015 Patients as Partners conference, put on by The Conference Forum.

“There are times when it seems we are asking patients for their opinions simply so we can paste them in a pre-defined place in an existing system,” she says. “That is not how a company should be treating one of its most critical stakeholders. As an industry we need to continue to find new ways to incorporate participant feedback in a way that is good for patients, their families, and caregivers. This will be beneficial for our companies and societies as a whole since all of these stakeholders are very closely aligned.”

Of course the problem for most pharma companies is figuring out how to put the patient at the center of everything they do when there are so many intermediaries between the discovery of a new molecule and a pill or injection a patient takes many years down the road. Which leaves us with the question: How do we reconcile what might take years or decades to change?

Develop A Patient Centric Approach

Schneider says that pharma companies all have an interest in creating a patient-centric approach to better serve the needs of trial participants if they are to successfully continue bringing new medicines to market.

“We have to let the wants and the needs of patients, as well as the science, guide everything we do in every dimension of our work,” notes Schneider. “We have to do that from the earliest discovery made in the lab until the last time any marketed medicine is used anywhere in the world. But along the way we also have to keep in mind exactly what we mean by patient centric. We can’t say that we’re going to invite patients to the table after we’ve already made most of the decisions that are going to affect them. In some ways, that is worse than not including them at all. We can’t ask patients what they think of something and then tell them we’re sorry, but it’s too late to fix it. They’re demanding more of a say in the medicines and trials, and rightfully so.”

In an ideal world, Schneider notes, we would completely redesign the whole drug development process around patients. It’s difficult to try and use mid-20th century approaches to try to develop and deliver 21st century cures. That approach is simply not efficient. But at the same time changing how we move a new therapy through the entire development process takes considerable time and resources. So the decision can’t be taken lightly.

For starters, Schneider recommends trial designers take a hard look at the tools available to them, not the ones they wish we had. While it would be nice to have a well-designed and well-organized system in place for including patients every step along the way, most companies simply don’t have that. Still, the voice of the patient needs to be heard.  

We can’t take our time doing this,” she states. “One of the first things I heard when I entered the industry around 10 years ago, and during 20 years of clinical practice, is that patients were waiting. But they are not waiting anymore. They are no longer waiting for us to act. They are acting on their own. We need to think about that. We can no longer afford to wait.”

Activism Forces Change

Schneider believes the patient demands pharma is seeing today are an extension of the movement that started in the 80’s and 90’s with patients who were infected with HIV. The signature chant at that time was “nothing about us without us.” She notes that activism changed protocols at the point of care sites, but also changed the way the industry developed, regulated, and reimbursed treatments. The ripples still reverberate today.

So how do we move forward with a reengineering of the drug development process?  

First, the industry needs clearer guidance from regulators on how it can and can’t interact with patients. The industry also has to bring more discipline to bringing patients into the drug development process, making better use of methodologies that are quantifiable and can be included in submissions to regulatory authorities.

“For me, this patient centricity movement has to focus on connection,” says Schneider. “How are we connecting with patients? Are we going to hide in a mysterious black box or are we going to be seen as willing, active, transparent, and relevant partners? We can move this connection process forward as long as we view it as an essential step and not a nice thing to do.”

Technology is certainly changing the ability of patients to connect with each other in unprecedented ways. Years ago, someone experiencing symptoms would pick up the phone and call their doctor. Today they jump on the Internet to get information and connect with others who have the same symptoms. Only then will they consider seeing a healthcare professional.  

Despite the changes in technology, pharma still has to convince patients there is value in connecting with the industry. That will only be done by proving those connections will be rewarding, relevant, and transparent.

“Building that connection is one of the reasons the Office of Global Patient Affairs was created at Pfizer,” notes Schneider. “The overriding goal was to raise the voice and experience of patients throughout the organization in a much more systematic way. We wanted patients to know their voice is imperative, at every level of the company.”

Preaching For The Patient

In fostering those communications, Schneider considers herself part-evangelist. Whether inside the company at meetings or outside the company at conferences, her primary responsibility is looking at what the company is doing and figuring out what it can do better. It’s also about taking experiences from one part of the company and sharing them with other parts of the company.

“We can say that rare disease is different from oncology which is different from cardiovascular,” says Schneider. “That’s absolutely true, but there is still a lot we can learn from each other across the company, across our industry, across advocacy groups, and via discussions with regulators. We absolutely need to share information with each other.”

One of the things Schneider is doing to make Pfizer’s patient centricity efforts more systematic and operational is piloting some new tools within the company. One of them, a self-reflection tool, hopes to allow teams to take a step back and ask themselves what they could be doing to become more patient centric.

Teams are pausing to ask what patient centric means to them, looking at their actions through the eyes of a patient, and asking how they can do things better. The effort is designed to both raise awareness and spread workable ideas across the company. One current effort is looking into how Pfizer can enhance diversity in its clinical trials.

Another effort involves having patients help design the trials. Pfizer has examples of when, before a protocol is finalized, patient representatives are brought in to give their opinion on whether or not it is feasible based on their lifestyle. “That has been very helpful in making sure the protocols we’re designing are more fully in tune with what patients need and want,” says Schneider. “I’m genuinely excited about some of the work that’s been done, particularly in people with sickle-cell disease. We have medical ethnologists who followed people around for several weeks, during every waking hour, to discover their hopes and fears. The lessons learned enabled team members to dispel a number of erroneous and pre-determined assumptions.”

Overcome The Challenges

One roadblock which has stymied patient centricity efforts in the past, and could continue to do so in the future, is misinformation and misperceptions. There are certainly naysayers who incorrectly believe that by changing the paradigm and systematically including patients in clinical trials, the cost of studies and the time needed to complete them will increase. Schneider believes the industry needs to move away from that type of thinking.

But at the same time, she does recommend listening to those concerns and properly addressing them. Just because something can’t be done a certain way doesn’t mean we should do nothing,” she says.

Properly embracing patients as true partners in the drug development process is a vital first step. “Do I have all of the answers?” asks Schneider. “No. Do we have a really long way to go? Yes. This is something that we are all struggling with. We have a long way to go but the effort is a worthwhile one.”