Get Real with Patients and Their Advocacy Groups

7th June 2016 (Last Updated September 24th, 2018 09:53)

Deborah Collyar, PAIR, offers insight into working with patient communities, explaining to researchers the keys to patient-centered research

Get Real with Patients and Their Advocacy Groups

This article follows a presentation I gave at the 2016 Arena International Clinical Operations in Oncology Trials West Coast Conference. For more background, check out "Patients ARE Your Endpoint."

Meaningful patient-centered research really must approach trials from a patient's standpoint. After all, clinical trials exist because people need better treatment, care, and prevention when they get sick, not just more options that don't help very much.

How to Position Products People don't want

People and payers care about outcomes, not products. Remember, patients don't choose their condition, they want a solution that will be as effective and as physically, emotionally, and monetarily painless as possible. A dive into market research before drafting a product development plan can help you design better trials that answer patient-oriented questions. Developing long-term relationships with patient communities can also lead to accelerated recruitment, retention, and market acceptance.

Once a mindset to produce real products for real people has been established, it's time to learn about the patient perspective. Patients want a definitive diagnosis, but may encounter a variety of doctors or even receive a misdiagnosis first. Once a disease has been diagnosed, patients want a cure, but there are very few real "cures." Treatment may alleviate symptoms or keep the disease at bay for a time, and while this is better than nothing, patients often become skeptical after feeling let down by the medical system.

Say what you mean in their words

Words matter when speaking to patients, and there are real problems with terms used in research and medicine. For instance, what does "complete response" really mean? A clinical trial may define it as a measured response during a certain timeline in the study, but patients hear that they are "cured" and don't have to worry about it anymore. The misuse of terms subtly erodes trust and creates irreparable disconnects that can affect retention and future recruitment. It is crucial, therefore, to use words that patients relate to, use them accurately, and make sure everyone understands how they are being used. In other words, build a clear context around the message that will be conveyed to patients.

Who can you talk to?

There are big differences between patients, patient advocates, and patient advocacy organizations. Each perspective can provide important insights at different points in the development process.

Patients in active treatment are rightfully focused on their own situation and search for answers. Knowledge about the disease can range from nothing to graduate-level expertise, often after careful research on the subject. Their main focus lies in decisions about treatments and survivorship. Too often, they find out that medicine is indeed an art, and labor over emotional trade-offs between possible remissions and the consequences of those treatments. In research, patients can help build an experiential frame of reference around the disease as they describe their experiences, hopes, and disappointments.

Patient advocates hopefully come from the patient world, either through their own condition or as a caregiver after initial treatment is over, and they may or may not be part of a larger group. Patient advocates often help with trial design, and can facilitate communication with regulators and professional organizations. They can also help spread the word about clinical trials to assist in patient recruitment and retention through a variety of methods (e.g. creating patient materials, serving on ongoing advisory boards) after verifying that studies meet true patient needs.

Patient advocacy groups can be a good source of patient input, but frequently have developed their own long-term agendas that may not always reflect current patient issues. Often, groups are represented by a few key people who want to represent "the patient voice" in national dialogs and legislative initiatives. Some of these leaders studied advocacy as a career and may, or may not, have direct knowledge about the disease. In the case of rare diseases, many organizations were founded by one patient's family, built on a base of other patients, and often cover all forms of advocacy at once. Their focus can be more similar to patients in active treatment than to a global perspective on the issues.

There are many different roles that patient advocates and organizations can play, and each person or group is motivated by at least one of these key factors:

1. Providing patient support or services.
2. Raising funds for various causes (including research).
3. Raising important issues that must be addressed.
4. Lobbying for regulations, such as those that protect patients or guarantee their rights.
5. Partnering with researchers to create relevant patient-oriented results.

It is critical to learn what motivates each individual and group. The first four types of advocacy listed above are more traditional, and may not work as well for clinical research. While passion can still drive patients and their advocates to eradicate the disease, the ones best fitted for research build an in-depth knowledge of the disease, the range of patients, and learn how research works. Patient Advocates In Research (PAIR) members, for instance, bring reality to research in two primary ways: 1) we provide patient experiences throughout the development process to create relevant clinical trials, and 2) we help identify and resolve barriers that thwart translation to clinical results.

How to Engage Patient Communities

The earlier patient input is incorporated, the fewer barriers are built into product plans and protocols. PAIR, for instance, has helped the National Cancer Institute (NCI) and the National Clinical Trial Network (NCTN) over the last 23 years in the following ways:

  • Review concepts and protocols to make them more patient-oriented.
  • Test feasibility of trials and approaches.
  • Work with sponsors, regulators and the ethics community to accelerate the process.
  • Help develop accrual plans and materials for sites and patient communities to create better understanding and acceptance.
  • Create plain language study result summaries so everyone can see tangible value in clinical research.

The goal is to create a long-term partnership that enhances, strengthens, and speeds up relevant clinical trial results for patients. Creating effective patient partnerships is a continual learning experience, but through the years, some key factors have surfaced:

  • Do not inadvertently use patients or their advocates. While sponsor goals count, those from patient communities are not there to solely solicit participants for clinical trials, especially if they have no input into the design. Too many existing trials focus on research and career goals instead of addressing real needs of real patients.
  • Build mutual respect and clarify terms and concepts as tenets of these partnerships. The fact is, those who represent patients have an important expertise that can help streamline the trial process.
  • Set proper expectations and ground rules to create enduring jargon-free communication, and regularly discuss lessons learned from all viewpoints.
  • Sponsors can help keep everyone up to date on emerging research and clinical trial advances to help these partnerships grow effectively.
  • Turnover exists on the patient side, just as it does in business. The long-term commitment required of patient advocates in research can challenge those who prefer a more direct form of advocacy. Unfortunately, patients also die from their condition or disease.

The patient community stands ready to help in many ways, but there is one step you and your colleagues should take before starting any patient-related process. Please eliminate phrases and mindsets that blame patients. For instance, patients NEVER fail treatments. In truth, treatments fail patients all too often. By re-orienting research, we can foster clear, effective communication together that can reap the rewards of targeted trials that answer real life questions. I look forward to continuing this dialog with you!

*Deborah Collyar is the President of Patient Advocates In Research (PAIR)

Deborah Collyar
President, Patient Advocates In Research (PAIR)
Deborah@tumortime.com
Twitter: @deborahcollyar
LinkedIn: http://bit.ly/1uHixTf
Blog: https://collyar.wordpress.com/