By Cheryl Lubbert, Health Perspectives Group
Consumers today are asked to make increasingly complex decisions around their healthcare. They have access to so much information, yet the level of detail and potential for confusion is only increasing. At the same time, social media has fundamentally changed the way people gather information and relate to each other.
Research show that consumers now have a high level of trust in information they get from people like them online.1 This creates an untapped opportunity for clinical development teams to have patients help other patients decide whether to participate in a clinical trial.
To gain more insight into this opportunity, we recently conducted a survey of more than 300 people, asking them about their knowledge of and experiences with clinical trials. The survey explores the opinions of people who have participated in a trial, cross-referencing their reasons for making participation decisions, as well as their preferred methods of communication about trials.
First, we asked patients who have participated in a clinical trial about their motivations and why they decided to participate. The results show that more than one-third (37 percent) of patients chose to enroll in clinical trials with the greater good in mind: to help others and advance research.
Next, we asked clinical trial participants to rate their experience in the trial. The survey showed that 68 percent of patients rated their experience in the trial as “very positive.” And 78 percent of respondents said they were “very likely” to participate in another clinical trial. In addition, 61 percent said they were “very likely” to recommend that a friend or family member participate in a trial, and another 23 percent were “somewhat likely” to make this recommendation — for a total of 84 percent.
Finally, we asked how those who had chosen to participate in a clinical trial how they found out about their trial. Most (34 percent) found out about the trial from their doctor, and 26 percent found the trial through an advertisement. Of those who saw ads, 13 percent saw the ad through social media, and another 16 percent saw the ad online. Only 2 percent heard about the clinical trial from another patient.
So here is a group of patients that is inspired to help others, motivated to advance research, and reports positive experiences in clinical trials. They are not only willing to go through the process again, but also are overwhelmingly willing to recommend that their friends and family participate in a trial. Yet almost none of them heard about a trial from another patient.
Advocacy Groups Connect Patients With Potential Trial Participants
Patients have an important role to play in spreading the word about clinical trial participation. Several patient and research advocacy groups have realized this and developed programs to connect patients with trial participants in specific disease areas. NephCure Kidney International, an organization that supports and funds research for the potentially debilitating kidney disease focal segmental glomerulosclerosis (FSGS), offers members a Clinical Trials Ambassadors Program.2 For the program, the organization has recruited patients and parents who have been through the research process, who can help explain it to others considering a clinical trial, sharing what to expect and why it is important to participate. NephCure describes the benefits of the program on its website: “Hopefully, talking to a Clinical Trials Ambassador can help eliminate some of the stress around participating in a research study and help you feel more empowered.”
The LUNGevity Foundation has a similar program for patients with lung cancer. Their Clinical Trial Ambassadors3 are volunteers available to offer information about their personal experiences with clinical trials by email or telephone to fellow lung cancer patients who are considering participating in a trial.
Building A Foundation Of Patient Engagement
Patient advocacy programs like this are a good start, but biopharmaceutical companies can provide such programs on a broader scale. Consider the possible impact on clinical trial enrollment if all patients could share their stories more broadly online with other people considering enrollment. Former participants could describe their trial experiences via social media, or address questions and concerns in a private, online forum, or through one-on-one peer mentoring sessions.
So how can clinical departments take this information and operationalize it to create patient engagement programs that impact clinical trial recruitment and provide other benefits? Most importantly, they must build a strong foundation that will support patients in their efforts to assist with recruitment, product development, and communications. The elements of this foundation are:
- leadership buy-in and planning
- patient-centric infrastructure
- privacy and security
- patient recruitment
- patient engagement.
Let’s explore each of these elements, with guidelines in each area.
Leadership Buy-In And Planning
The first step is to secure support for patient programs at the highest levels of leadership within your organization. The internal structure, resources, and budget involved to develop a robust patient program require a unified vision and commitment. Next, it’s important to include patient programs in your internal planning and budgeting process. Make sure you have the funds to implement and maintain patient programs now, over the next year, and beyond.
Build in internal company structure that enables shared patient feedback throughout the organization. Now is the time to break down any internal silos and barriers and instead create internal education/learning centers, making it possible for teams to share success stories and what isn’t working, and make referrals to firms that can help. This sharing of information and best practices speeds up time to success by learning from others engaged in the same types of activities.
One possible implementation of such a structure is a central patient network team that spans all departments. This type of multi-departmental network can be centrally funded to take the burden off of any individual department and help to ramp up patient-centric efforts:
- Marketing, PR, clinical, medical affairs, government affairs, and other departments can all tap into the network and work with patients.
- Each department is responsible for budgeting and managing their own programs, but all are following the same policies and procedures.
- Because the overall cost of setting up the network comes from a central source, this makes it possible for departments with smaller budgets to access the patients in the network, as well.
Privacy And Security
When working with patients, the best way to ensure compliance is to have an organized and systematic approach in place for recordkeeping. From the beginning, develop internal patient policies and procedures that ensure everyone is working in the same compliant way and keeps all data and information encrypted and secure. Make sure there are no sticky notes, emails, or spreadsheets floating around with private information.
Also, approved scripts to guide conversations, release forms for proper permissions, and guidelines for appropriate information sharing should be centrally available to all employees who might work with patients.
One way to ensure privacy and security is to keep all patient information in a HIPAA-, PHI-/PII-(personal health information/personally identifiable information) compliant database that allows tracking of how each department engages patients. As your program grows, this type of system has the added benefit of tracking which patients assist with which type of programs. A secure, central database also makes it possible to easily track any specific pharmacovigilance and MedWatch requirements if you engage with patients who are already being treated with your company’s products.
Once the infrastructure and systems are in place, it’s time to find patients who are willing to share their experiences and perspectives with your company, and later, on behalf of your company. To identify and recruit the right patients for each potential program, it’s best to take a holistic approach, analyzing internal knowledge, the disease state, and patient demographics to devise a customized identification and recruitment plan. Some examples of external channels that can be used to find patients include:
- outreach through a disease or brand customer relationship management (CRM) database
- physician outreach
- advocacy group outreach
Using the compliant processes and materials you put in place when building your patient-ready infrastructure, you can begin to reach out to patients and see if they want to opt in to assist. Start small at first, focusing on finding a few patients that are the right fit to begin to build programs, adding as you have success and increase your familiarity with the patient programs and how they work.
Now that you have some patients ready to share their perspectives and experiences, you can implement initiatives internally to gather insights for your teams in different departments.
- Patient interactions with teams – Informal, internal lunch meetings that bring together patients and employees can provide eye-opening discussions and insights to both groups. Employees can learn about living with the diseases they are working to treat, giving them an empathetic point of view that they can apply long after the meeting is over. Patients can lend their voices through follow-up voicemails and emails, providing further motivation to employees.
- Patient advisory board – These one-time meetings bring together 10 to 12 patients and caregivers to share their patient journeys and perspectives on a range of topics, from recruitment materials, to wording of trial onboarding materials, to the clinical trial protocol itself. If all goes well, consider expanding to a patient advisory council, so the same group of patients can provide longer-term ongoing feedback, both in person and virtually, as you develop your clinical trial program.
Once you have opened the channels of communication and interaction with a group of patients, you can expand your programs to include support around clinical trial recruitment.
- Clinical trial alumni platforms – These communication programs provide opportunities to obtain feedback from and share disease education and trial milestone updates with opted-in members of the engaged clinical trial participant population.
- Patient speaker programs – With training on compliance and privacy guidelines, clinical trial alumni who want to share their personal stories can speak at internal and external events. The information they share would be limited to their experiences from participating in a clinical trial, excluding discussion of trial results.
- Patient-to-patient mentor programs – Trained clinical trial alumni can serve as mentors, assisting other patients through private one-on-one communication by email or phone. Mentors would not have to have participated in a clinical trial for the disease state, or even for a trial conducted by your company. They just need to have previously participated in a clinical trial and be willing to share their experience with others.
While it’s true that these approaches require a commitment of time and resources, as well as strict attention to privacy and security, the potential payoff is significant. Creative and compliant programs built around the patient experience have the potential to dramatically change clinical trial recruiting — and actually improve the outcomes of the clinical trials themselves. In our next article, we will take a closer look at how the patient perspective, accessed early enough in the clinical trial planning process, can help improve trial design and reduce costs.
- Nielson, “Global Trust in Advertising: Winning Strategies for an Evolving Media Landscape,” September 2015.
- NephCure Kidney International Clinical Trials Ambassador Program, https://nephcure.org/research/clinical-trials-ambassador-program/
- LUNGevity Clinical Trial Ambassadors, https://www.lungevity.org/support-survivorship/get-connected/clinical-trial-ambassadors
About The Author:
Cheryl Lubbert is president, CEO, and co-owner of Health Perspectives Group, a group of companies working to transform healthcare by tapping into the consumer experience. She has more than 25 years of senior management, commercial development and patient engagement experience at Fortune 500 biopharmaceutical companies, including Abbott Labs, Bristol-Myers Squibb, Immunex, and Amgen. For more info: www.hpgroupllc.com.