By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
Patient-centricity continues to be the hot buzzword in clinical trials. With greater patient-to-patient interactions via the internet, social media, and advocacy groups, sponsor attention to the wants and needs of patients has never been greater. But for all of the attention being paid to it, questions still linger over what it really means and what is actually being done.
For this patient-centricity roundtable, I attempted to bring together some of the most innovative and patient-centered minds in the industry to discuss the efforts being made and what CROs can do to assist with the process. Included in this panel discussion are:
It appears patient-centricity/patient voice will continue to be a hot topic in 2016 and beyond. Where does your company currently stand in regard to implementing patient-centric practices? Can you share a few success stories?
Roslyn Schneider: The “success story” here at Pfizer is a clear commitment across functions and levels of leadership to advance patient-centricity in a manner that’s beneficial to the patient community. There are serious, disciplined, and often complementary efforts under way to embed patient-centered approaches into our plans and operations and to apply the resources we need to implement our thinking. In addition to the formation of the Office of Global Patient Affairs, we’ve had patient-centered roles and teams focusing on innovation, advocacy, and policy across our organization. There are additional new roles and work streams to build on relationships that support change.
Other examples are seen in the inclusion of a patient expert on Pfizer’s external bioethics advisory panel, another on an external review panel that reviews Pfizer’s independent grants for learning and change. We have included patients and advocates as members of multidisciplinary advisory boards in several areas of Pfizer and engaged them earlier in the process to better inform decision making.
Kathy Vandebelt: Lilly is focused on making clinical trials an accessible healthcare option for patients and their healthcare providers. Our clinical innovation and clinical development staff continue to learn more from patients about what they need to better participate in clinical research. Put another way, we want to embrace this notion of evolving along the continuum of “to-for-with” as it pertains to our relationship with patients and how we aim to collaborate with them.
In 2016, we are expanding Lilly TrialGuide (www.lillytrialguide.com), an enduring web presence that helps patients find information about clinical research and trials that may be appropriate care options for them. We are involving patients in the design of protocols through a collaborative effort with the Lilly clinical research staff, investigators, and study coordinators. We are showing our appreciation for patients who contribute to clinical research and are now providing them with layman summaries of the results at the end of the study. We believe this helps patients understand their contribution.
Beverly Harrison: At Janssen, we thoughtfully and systematically place the patient voice at the core of how we operate by implementing programs that address patients’ self-expressed needs. A variety of programs are under way to achieve this, including — amongst other programs — transforming how we evaluate patient requests for compassionate use, enhancing the patient experience in the clinical trial setting, committing to transparency of the resulting data, and creating an internal infrastructure to guide employees in the capture and implementation of the patient voice.
Within the clinical trials realm, an active program we have underway is called “Patient Voice in Trial Design.” The ultimate goal of this program is for every Janssen trial we design, the patient voice will be just as loud as the many other voices that we have historically sought to guide design decisions, such as key opinion leader physicians. This program involves gaining real world experience with a variety of methods for seeking, listening to, and incorporating the patient voice into clinical trial design and operational planning. To do this, we are in the process of building a “living” toolkit that we can deliver to the organization to provide the know-how and necessary infrastructure. In parallel, we continue to explore novel methods that can be added to the toolkit and to maintain a repository of patient insights for future reference.
Tina Shah: Patient-centered care is a concept that is becoming increasingly important in our health system, and we are targeting ways to streamline the care we deliver in various settings (e.g., ICU, inpatient, outpatient) to revolve around the patient. One effective area of patientcentered innovation has been with our patients who have Chronic Obstructive Pulmonary Disease (COPD), a disease that causes trouble breathing. COPD is a condition now subject to the Medicare Hospital Readmissions Penalty, which seeks to improve patient-centered care by penalizing hospitals for excess readmissions. Our hospital developed a comprehensive care program led by a nurse practitioner that aligned care and implemented evidence-based practices for COPD patients in the inpatient and postdischarge settings. Two critical components of our patient-centered program are: 1) empowering patients through inhaler and disease education; and 2) ensuring continuity with a follow- up visit with our nurse practitioner within one week and a 24-hour patient access line that is also staffed by the same nurse practitioner. Our preliminary results have demonstrated a significant reduction in all-cause 30-day readmissions. At the same time, our patients tell us they love the teaching and feel more knowledgeable about their disease, but have helped us to uncover areas for improvement, such as ensuring that we schedule appointments that fit with their schedules and that we make sure they have all the needed prescriptions in hand before leaving the hospital.
Are CROs able to play a role in protocol design or bringing patient perspectives to the table?
Harrison: CROs can play a very important role in our quest to obtain patient perspective into the design and operational implementation of our trials. We are proponents of “supplier-enabled innovation,” where we actively help our key suppliers acclimate their products and services to work in the highly complex world of industry-sponsored trials. CROs can enhance our ability to seek and utilize patient voice to guide clinical development decision making by developing needed infrastructure and services to reach out to the right patients in an efficient manner to obtain actionable insights.
"CROs can play a very important role in our quest to obtain patient perspective into the design and operational implementation of our trials."
Beverely Harrison, Janssen
Vandebelt: We haven’t relied on CROs much, as we’ve found success in either working directly with patients or trusted patient-focused organizations/patient communities. In fact, for over a year now, we’ve been collaborating with patients through our own internal program. The program is a collaborative framework that allows us to incorporate investigator and patient input into our study designs, enabling us to work in partnership with patients around the globe.
Schneider: While I can’t comment on specific examples, the way CROs help Pfizer incorporate the patient voice is by executing clinical development plans that are more consistently incorporating the patient voice.
Christine Pierre: I agree that it often comes down to clinical plans. Patients can be accessed through the relationship CROs have with sites. CROs that foster partnerships with sites, as opposed to simply performing transaction-based activities, have the opportunity to leverage that site relationship to better understand the site’s perspective. This will lead to greater opportunities to provide value to sponsors.
The old model of patient recruitment had pharma going to a CRO, the CRO engaging with sites, and the sites and investigators recruiting patients. How much has that model changed with the advent of social media and patient advocacy groups?
Pierre: Thus far, most sites are reporting that social media has not had a meaningful impact on patient recruitment. Part of the reason for that is sites generally do not actively engage with patient advocacy groups. However, when the sponsor or CRO works to make that connection, the results can and have been very powerful. Patient advocacy groups are in the business of actively ensuring the patient’s voice is being heard, and they can provide a unique and meaningful dialogue with the research community.
Shah: That model still seems to be the predominant method of patient recruitment in the U.S., but social media is complementary and is a relatively untapped arena. Social media allows for a greater audience and also personal experiences from patient to patient that can increase the interest and credibility of studies from the patient perspective. Pairing with patient advocacy groups on Twitter, for example, can increase the reach to the particular patient population of interest in a relatively lowcost way. Social media will continue to increase in importance for patient recruitment and is a great tool to get the right patients into the right trial.
Schneider: Christine and Tina both make good points, but from the sponsor perspective, I also see the recruitment model changing to better identify eligible clinical trial participants where they are rather than where we are. Engaging patient advocacy groups early and in a disciplined way is valuable in understanding and overcoming potential barriers to patient recruitment and retention. Strategies may extend beyond the “traditional” to utilize the work of patient advocacy groups, social media, community leaders, and others.
"Thus far, most sites are reporting that social media has not had a meaningful impact on patient recruitment."
Christine Pierre, Society of Clinical Research Sites (SCRS)
Vandebelt: Those are great comments. I would just add that for many conditions, sites and investigators will typically recruit patients who are already known to them. Through the use of advertising and other relevant content, new patients unknown to the site may also become aware of the study.
The internet provides the opportunity for many more patients to become aware of clinical research as a care option. Research has shown that 42 percent of the world’s population uses the internet, the average internet user spends two hours on the web via their mobile device, and 62 percent of smartphone owners used their phone to look up a healthcare condition within the last year. This is a trend we cannot ignore. Through the internet and social media, patients also have the opportunity to share their clinical research experiences with others, including a large number of potential patients. This is an opportunity for many more patients, previously unknown to the sites and investigators, to be informed about a clinical trial and potentially seek additional information about participating.
Harrison: The prevalence of organized patient groups has played a major role in shaping the recruitment process. Patients increasingly look to their peers for advice on care options, and peer guidance can be a big influencer of patients’ decisions to participate in trials. It’s normal now for the patients to be the ones approaching researchers — both sites and industry sponsors — versus the other way around.
We have a great example from a project we did in 2013 of how a digital patient community, operated by a major CRO, enabled recruitment for a research study. We ran an entirely “direct to patient” noninterventional study, whereby patients who were part of the CROs-owned patient registry were invited to join a study that required submission of health records and a specimen for genetic testing to 23andMe. In just 18 weeks, 1,000 patients were recruited, data provision rates were very high, and the cost of conducting this study was 50 times lower than if we had used a traditional site-centric model.
We often talk about how we need to give the patient a seat at the table during the trial design process. Is it important to also have the CRO, the investigator, or someone from the clinical site seated at that same table?
Harrison: It is very important to have all stakeholders at the table and giving input into clinical trial design. Each has its own unique perspective, and that is vital to designing R&D programs that work — both scientifically and operationally — and ensuring relevant products that deliver value for patients emerge at the end. What one stakeholder can learn from the other in the process is equally important and can help shape and improve the individual role they play. Forums enabled by technology can greatly help to bring all these parties to the same table when it’s not logistically possible to literally do so.
Schneider: It’s absolutely essential, especially at Pfizer where we rely on successful partnerships with leading CROs. We have CRO partners who are asking for seats at the table when we are engaging patients for insight, and we encourage them to participate. There are several “tables” where we are convening with stakeholders, including in the clinic where the patients, coordinators, investigators, and others may be brought together to simulate clinical trial protocols in a clinical setting.
Pierre: Thank you, Roslyn. As someone who represents the sites, I am incredibly encouraged when I hear comments like that. When you think about it, sites are really an extension of the patients in many ways. The sites are the only part of the research study team that have the privilege of actively engaging with the patient. Most sites typically conduct multiple studies and, therefore, have a unique vantage point of seeing which study designs actually work and what challenges are faced by others. At SCRS, one of our goals is to provide the site’s perspective to many forward-thinking sponsors and CROs to ensure the voices of the site and the patient are being incorporated into the trial design process.
Shah: I completely agree — this is very important. That qualitative piece of information, the patient voice, allows investigators to quickly know what will and won’t work in practice. In order to maximize enrollment and reduce attrition, getting the perspective of all stakeholders right up front would be very helpful.
The recruitment rate for trials is still very low, and a recent report stated that 85 percent of cancer patients are still not aware that clinical trials are a treatment option. What can sponsors, CROs, sites, and investigators collectively do to make patients more aware of trials and get greater involvement in them?
Shah: Great question. Getting the message about available trials to patients can be tough due to the wide variation in patient use of social media, as well as patient understanding of their medical disease and what a clinical trial offers and entails. A two-pronged approach at the level of the bedside and through the internet will allow us to reach more patients.
Making providers aware of relevant clinical trials for their patients is key. This should be done in a time-efficient manner with feedback and updates to providers that refer patients for trial screening. Providers should also be armed with an easy way to connect their patients to sites, investigators, and CROs, whether it is via handouts or an email that can be forwarded to their patients. On the media end, a patient-friendly website that details available trials with links to disease websites often frequented by savvy patients would also help increase knowledge of studies and enrollment. The website should be updated frequently so the information does not become stale. Partnering with disease-based organizations that have already built patient networks can further leverage the effort to inform patients of the benefits of trials.
Vandebelt: Despite the low enrollment rates, many patients who participate in a clinical trial report having a positive experience. Ironically, a majority of patients don’t actively discuss their trial experience. Why is that? If there are ways we can enable patients to have more meaningful conversations with their loved ones, caregivers, social networks, and physicians, then maybe we can move the needle on raising awareness. That is one of the reasons Lilly is exploring ways to appropriately provide patients with overall trial results or even their own clinical data to enable meaningful conversations about their participation in a way that is respectful, ethical, and informative.
Schneider: There are many reasons why people may not consider a clinical trial as an option, including but not limited to the lack of awareness or preconceived notions of what the clinical trial experience might be like. These are issues in both the patient and the healthcare provider communities. Improving awareness of clinical trials in patient communities may be done through advocacy groups, local community, media, and social and other channels. Primary care, specialty healthcare providers, and health systems may be engaged in a more holistic, coordinated fashion to help identify the most appropriate patients for specific trials. This approach helps ensure that patients and their healthcare teams are better prepared to consider a clinical trial as an option.
Harrison: “Collectively” is the key word here. No one party can address this problem on its own; we all have to work together collaboratively. Patients themselves can help too, to spread the word to their peers, and industry, sites, and CROs can help enable this. Within Janssen, we are currently investing in a comprehensive program that will greatly enhance the accessibility of information about our sponsored trials and expect the program to go live by the end of the year. Janssen also participates actively in TransCelerate, CTTI (Clinical Trials Transformation Initiative), and other multistakeholder and industrywide forums that seek collaborative solutions to the problem of low trial participation rates.
Pierre: I agree that “collectively” is the key word. For years we have conducted surveys and attempted to document the reasons why the general public does not participate in clinical trials. It is now incumbent upon us as a collective industry to tackle these very difficult and far-reaching issues. Awareness, knowledge, and accessibility all need to be addressed with the general public to change the perception of trials and the entire industry. Lastly, respect for the patients who do participate needs to be acknowledged. Study results and the patient’s own clinical data should be returned to them at the appropriate time to recognize and thank them for their critical and unselfish contribution. Those contributions to the general body of scientific knowledge are what will allow us to continue to bring new treatments to patients.