By Jeffrey S. Kasher, President, Patients Can’t Wait, LLC
Every biopharma company talks about putting the patient at the center of everything they do, incorporating the voice of the patient and being patient-centric. However, very few companies are actually doing it. Why is it so hard to conduct clinical development in a patient-centric manner? What actions can we take in 2019?
Barriers To And Misconceptions About Patient-Centricity
One of the biggest barriers to adopting a patient-centric approach is biopharma’s risk-averse culture, as demonstrated by the following common fears and questions: Will the regulatory authorities accept a new way of doing something? Will I get penalized by my boss if a new way doesn’t work? We have always done it this way; why change now? Although the new way looks very promising, can you please come back and discuss it with me after you have successfully tried it on someone else’s project?
Next, it is difficult for a company to accurately estimate the return on investment (ROI) for a new technology or approach. While this is true, it is no more difficult than a company’s research division estimating its ROI for pursuing a new molecular target or technology.
Furthermore, most biopharma company executives are more focused on maximizing shareholder value than on benefiting its targeted patients.
However, in not providing patient-centric clinical development, biopharma companies have created negative impacts. Of significance: the number of procedures in Phase 2 and 3 clinical trials has multiplied, the percentage of patients who enroll in clinical trials remains under 3 percent, the patient dropout rate during clinical trials has increased, the cost of clinical research and drug development has skyrocketed, and 80 percent of trials do not enroll in their planned time frame.
I am not advocating stupidity or recklessness in clinical development; rather, this is a call for listening and acting in a different manner. Sometimes you must slow down in order to go fast. Albert Einstein is widely credited with saying, “The definition of insanity is doing the same thing over and over again, but expecting different results.”
Definition Of Patient Centricity
Patient centricity involves doing the things that optimize the give to get for patients. In participating in a clinical trial, patients give two precious things: their time and their bodies. They are volunteering hours of their time, while agreeing to put molecules into their bodies for which the safety and/or efficacy is being tested. Throughout the length of a clinical trial, patients are subjecting themselves to bodily fluid sampling, body scanning, and probing. Clinical trial patients are our industry’s silent and courageous heroes.
In addition, patients want to get three things: convenience, value, and caring. In order for patients to continue to live their lives, work, and play with convenience, they want the clinical trial to be simple and transparent. Patients want to gain some personal value, whether that is having access to a new medicine, improved health, their life saved, or wanting to give back by making a contribution to society. Lastly, patients are human beings who want to feel cared for; they want empathy, touch, engagement, connection, and want to be told “thank you.”
So, how do you become patient-centric? Simply put:
Three Patient-Centric Actions You Can Take In 2019
1. Make your trials more accessible to patients.
Time is a precious and valued commodity for both patients and their very busy healthcare providers. Sponsors need to develop clinical trials that healthcare providers will be more likely to adopt, similar to a standard of care, by simplifying their protocols and removing procedures and tests that don’t support primary endpoints or patient safety. In doing so, trial visits will become briefer and may become fewer in number.
There are numerous ways sponsors are increasing clinical trial accessibility. Some are taking their trials to more socioeconomically and geographically diverse communities, while others are starting up sites after a patient is identified (e.g., Novartis’ Signature Trial). We have also seen the emergence of companies that conduct siteless/virtual trials. While these methods increase trial access to some patients, they are not practical for all. Sponsors should develop hybrid clinical trial designs. Hybrid designs are appealing because they offer patients the flexibility of having some trial visits at a traditional site while other visits may be completed via telemedicine or by home visits. Furthermore, given the very high density of pharmacies in the United States, it should be feasible for a patient to complete a study visit at their local corner pharmacy.
Finally, one evolving option for increasing patient access to trials is Clinical Research as a Care Option (CRAACO). Imagine that you have rheumatoid arthritis, and treatment with two different anti-tumor necrosis factor (TNF) agents has been ineffective for you. What if your healthcare system was conducting a clinical trial for patients with RA who had failed two anti-TNFs, like you? Your doctor could discuss this trial with you, and you would then go to your familiar healthcare environment for your visits. This CRAACO provides patient-centricity because the patient gets convenience, value, and caring.
2. Design and execute 21st-century protocols.
Thirty years ago, a clinical development team would review their company’s clinical database, comb the research literature, and speak with key opinion leaders to inform the design of their next trial. Today, we can and must incorporate insights gained from analysis of real-world data to optimize trial design. Along with advanced analytic capabilities, we have disease, healthcare, genetic, lifestyle, and socioeconomic data that enables rapid analysis of structured and unstructured data.
Similarly, we have the opportunity to utilize more meaningful patient endpoints, both digital and non-digital. This builds on the opportunity to include wearables, in vivo sensors or monitoring, and digital apps in today’s clinical trials. These tools enable more passive collection of enormous quantities of data for demonstration of both efficacy and value and provide 24-hour, seven days a week monitoring of safety signals in many cases. Again, I am not advocating a blind jump into using new technology in trials. Rather, I am promoting its use in an addendum or in parallel to conventional measures as a first step to its validation and in order to mitigate its risk in trials. Clinical trial incorporation of new technology can also be accelerated through biopharma partnering with emerging and established technology companies to co-develop solutions.
3. Engage and inform patients.
Start by selecting sites that spend time with their patients by listening to them, answering questions, and showing empathy. Next, use electronic informed consent (eICF). With mixed media available on a computer tablet, sponsors have the opportunity to truly inform patients about the trial they are considering. Prior to signing a patient up for a trial, ensure the patient and his/her caregiver team is fully informed. This not only results in greater trial retention, it is the right thing to do.
Today’s trials can keep patients engaged through mobile reminders (e.g., visit on Thursday, take your drug with food) and by providing disease information and the status of the trial. Some sponsors are providing select data to patients after each of their visits. Others have established moderated trial communities for the participants, thus providing an efficient and effective mechanism for answering questions.
After a trial, send a thank you note, provide a summary of the trial (this will soon be law in the European Union), provide trial results when available, and inform each patient of the drug treatment they received. Keep patients updated on the development status of the investigational drug and let them know when it is approved.
Every person I have ever met in a biopharma, clinical research organization, or healthcare-related technology company goes to work (does what they do) in order to benefit patients. Today, patients across the globe need and can’t wait for medicines currently moving through our biopharma pipelines. A patient-centric approach to clinical development will result in getting innovative medicines to these patients faster. It is 2019. We can and must move from just talking about patient-centricity to taking action in delivering it to patients.
About The Author:
Jeffrey S. Kasher, Ph.D., president of Patients Can’t Wait, LLC, is a known pharmaceutical development change expert with 28 years of experience at Eli Lilly. His expertise includes novel product development from bench through market launch, research and clinical trial leadership, innovation center start-up, as well as new industry paradigm creation. He is passionate for improving clinical trial outcomes, bringing patients and research sites into the development process, and dramatically decreasing drug time to market. Kasher is currently on the board of directors of Javara, Inc.; the advisory board of Antidote Technologies, Ltd., Be the Partner, Inc., HealthCarePoint.com, and ZS Associates, Inc.; and a consultant for The Avoca Group, Inc., PPD Development, LP, and Praxair, Inc.. You can connect with him on LinkedIn.