Clinical Researcher—January 2018 (Volume 32, Issue 1)
The pharmaceutical industry has been aggressively moving toward incorporating patient-centricity into its drug development process. While the focus has been largely driven by marketing teams, the emphasis on the clinical process has been growing at an accelerated rate. Rather than sitting in silos, patient-centricity has fast become a function within every workstream.
If we start to look at patients as consumers, then we start to think a little differently. For years, the HIV and AIDS community (i.e., patients with a clear understanding of their needs) was driving the push for research and drug development, and the result was incredible advances in antiretroviral medications. If we can engage the patients in our clinical trials as consumers and put them at the center of research, we are likely to end up with more efficient studies, and ultimately better advances in critical drug development.
Make the Product Appealing—Avoid Protocol Design Flaws
When we look at the earliest opportunity to incorporate patients into the drug development process, it starts with protocol development. Sponsors are not always able to include the patient voice in protocol planning as often as they should.
All too often, the protocol is created without the ideal patient in mind. In fact, the protocol often is designed for a patient who doesn’t actually exist. Consequently, protocols undergo numerous costly and time-consuming amendments in order to ensure the study will be able to successfully recruit patients who will meet eligibility criteria.
If we incorporate patient feedback earlier into protocol design, we can help sponsors ensure that protocols are drafted for real patients. In addition to the inclusion and exclusion criteria of the protocol, many patients are able to weigh in on the type and timing of clinical assessments needed during the study.
Patients who have lived with their disease for a long time know when to expect flare-ups and the intervals between them. So, while a protocol might be drafted with testing set for every three months, patients who expect changes to occur within six weeks can inform the study clinicians to design testing that is more reflective of their reality.
However, this approach must also be balanced with other factors; we cannot just ask patients what they want and create a protocol that only meets their desires. Part of a patient-centric approach also includes a responsibility on the part of sponsor, contract research organization (CRO), and study site representatives to educate and inform patients about the research roadmap and why they are being asked to undertake specific procedures.
If a specific test has been included that is not considered standard of care or routine for a patient to undergo, patients may understandably push back, questioning the need for that procedure—especially if it’s invasive. We often depend on our clinical sites to manage these conversations without supporting them with educational aids. If we learn early on that a specific procedure may cause concern for a patient and will be a roadblock to participation, we can very quickly work to ensure that materials are created to help educate the patient.
Understanding Consumer Needs—Using Technology to Support Patients
Consider all the tools now available that make our lives easier to live; we should embrace new technologies as part of the clinical trial experience. A decade ago, we were consumed by step counters, keen to improve our own activity levels. Fast forward to the age of smart phones and smart watches, and our steps and other activities are closely monitored every day.
We accept that a watch may vibrate to tell us to stand up or move and, for the most part, we obey. Within a clinical trial environment, sponsors are using smart watch–style devices to measure patient activity and collect simple data as they go about their lives, instead of bringing that patient back to the clinic. More often than not, we dismiss the use of such technology in the belief that it is too invasive, when in fact many patients are monitoring far more themselves on a daily basis.
Multiple procedures coupled with a grueling visit schedule can be a deterrent for potential trial participants. Insurance companies and other healthcare providers in Europe and the U.S. now provide virtual office visits to meet patients where they are.
Instead of making an appointment and having to leave the house to visit a primary care physician, many patients now opt for virtual visits, such as speaking to a physician or nurse practitioner remotely via video chat. The same principle can and should be applied to studies where routine visits can be managed through another method, such as the use of biosensors and a telehealth or visiting nurse visit, rather than an in-office study visit. This type of flexibility can be invaluable to patients who may not have easy access to transport, or who are physically unable to commit to multiple study visits over a short period of time.
We need to look beyond traditional practices (which often have shortcomings) and recognize the inherent advantages of what we are using every day to enhance our daily living. The latest gadget from the next Consumer Electronics Show might just make a difference in how we interact with patients during clinical trial participation.
Inform the Consumer—Educating Patients About Clinical Trials is a Critical Step in Recruiting Them
Closer collaboration can make for a much more robust patient experience all around, and we can initiate this partnership before the trial even begins.
Many patients are completely naïve to the clinical trial process, until it is something they are asked to consider by a physician. Other patients who have failed multiple drug regimens quickly become very well-versed in research through necessity. When we start speaking to patients during protocol development, we should also consider this wider educational need.
From a patient recruitment perspective, we can hold focus groups to review the formats and contents of draft promotional materials, the impact of key messages, and more. However, this isn’t always a standard step in the study development process. More emphasis needs to be given to education to ensure patients truly understand their commitment to the study.
For example, an informed consent form (ICF) that has been reviewed by patients before finalization can provide insight into provisions that patients truly do not understand. Language can be adapted to ensure that the finished piece (along with the protocol) is truly patient-centric. Many sponsors now create ICFs using language patients can better understand. This is not a simple process, and requires the support of many others involved in research, including institutional review boards (IRBs), in understanding the need for a better way to present ICF language to patients or their caregivers.
Often, a patient-centric approach requires holistic consideration of the patient’s lifestyle. While patients are in the throes of their disease and working through many different clinic visits and procedures, caregivers are the anchor points for that patient. It is just as important to listen to the caregiver to understand the full picture of patient care.
Many protocols now even demand caregiver or study partner consent. This is crucial, especially in studies where patients may not have full capacity themselves to consent and understand study participation. The additional burden put on caregivers in managing patient care, coupled with clinical trial participation, should not be underestimated.
Educating patients and caregivers can take many forms. However, traditional methods (i.e., printed brochures and study information packs containing visit schedules and step-by-step guides to preparing for each visit) go a long way to ensuring patients and caregivers are informed. These tactics that were first implemented 20 or more years ago still have a critical role here. While many patients will accept SMS reminders and other study-related alerts received via their smartphone, often a phone call from their study nurse will go much further to ensuring their ongoing commitment to study participation.
Know Your Market—Before Educating Patients, We Need to Find Them
Sponsors and CROs tap into an arsenal of many different approaches to reach the target patient population, both online and offline in nature.
Not all patients are online or know how to navigate search engines to find the information they need. Many patients still prefer to have personal interaction and respond better to direct site contact within the local community. Helping sites to build relationships with local patient advocacy chapters or ensuring their presence at local events is now an integral component in many patient recruitment programs.
Forward-looking recruitment specialists borrow a page from the consumer world—the consumer buying decision process model. This five-step process [1) problem identification, 2) information search, 3) evaluation of alternatives, 4) purchase decision, 5) post-purchase decision] can very easily be compared to a patient’s decision-making process regarding clinical trial participation.
Translated to the context of clinical trials, a patient might come to realize the need to do something different to address his or her health situation. For instance, a multiple myeloma patient who has exhausted all therapeutic options might recognize the need to try a new clinical trial, prompting research into clinical trial options and selection of a study that may be fruitful. Alternatively, patients with rheumatoid arthritis or asthma who aren’t doing well on their current medication might be a candidate for participation in a clinical trial, but may want to exhaust all other treatment options first.
Patients ready to take the next step can only do so if they feel equipped with the right level of information. Today, patients can choose from numerous sources of information—online, word of mouth from a physician or family member, or a community health event, for instance. Understanding your target patient population and where to engage with them can be a crucial step in building a successful patient recruitment strategy.
What We Can Do Right Now—Listen to the Patient and Glean Insights
In order to engage patients early in the drug development process, we first need to open that dialogue. Online patient communities—groups of individuals organized by disease—are often a good starting point to reach engaged patients already talking about their disease. These groups can help sponsors and CROs gain insights into disease states to truly understand the patient perspective. New online communities are emerging every day, reflecting the growing number of patients who want to talk about their medical condition and connect with other patients.
Taking this further, conducting advisory boards with patients and advocacy groups can help sponsors and CROs gain a greater level of insight and interaction. The information gained from patients during these meetings can be invaluable. Likewise, holding “patient day” events enables everyone connected with drug development to have the opportunity to hear from patients directly. This personal interaction often leads to a greater understanding of the challenges patients face in their daily lives and the considerations that must be made.
For many of us who work in the industry, the only opportunity we have to hear from patients is during industry meetings. In recent years, many conferences have featured at least one track focused on the patient, and by listening to those sessions, we are reminded why we come to work each day. The patient points of view challenge us to remain fixed on the need for greater patient-centricity in the work we do. Ultimately, we need to continue to speak to patients (and their caregivers)—and more importantly, listen to them as they share their experiences living with diseases, as survivors and as unique individuals.
Considering patients as consumers challenges us to shape our product—the clinical trial experience—to meet the evolving needs of patients. Putting patients at the center of research demonstrates a true understanding of the marketplace, and ultimately provides a better experience for both the patient and the sponsor.
Marie Emms (firstname.lastname@example.org) is Head of Global Clinical Trial Engagement at Syneos Health (formerly INC Research/inVentiv Health).