When it comes to clinical trials, the success of an investigational treatment is based on a set of metrics that the research team can quantify. This is the gold standard of assessment, but decisions are made on data, and may not reflect the reality of patients’ lives, or the burden of their disease. However, more organizations are realizing the value of the patient’s perspective in clinical research (i.e. patient centric design), by pairing patient insights with clinical data to guide decision-making.
Take for example a clinical trial that is testing a new medicine for psoriasis. Researchers will usually base their assessment of the drug on the resulting redness, thickness and scaliness of treated skin patches. This is compiled in an official rating scale known as the Psoriasis Area & Severity Index (PASI).
While this method has its merits, it also has limits.
What Is Most Important to Patients?
For patients living with psoriasis, they often struggle with feelings of embarrassment depending on how bad they perceive their skin problem to be. Can this new treatment help improve their self-confidence? Could it allow them to do things they’ve been unwilling to do for years?
They want to know how a new treatment will allow them to enjoy a better quality of life.
Look at cancer clinical trials…
Should we be solely concerned with how this drug impacts cancer cells? An investigative treatment may be able to extend a patient’s life, but if it isn’t in a meaningful way, should that be considered a success? Patients living with life-threatening conditions are usually more concerned with improving their quality of life, rather than just extending it by a few weeks.
Recently, it has become very apparent that we should be taking note of what matters to patients in addition to the traditional research benchmarks. This can provide a more comprehensive picture of how effective a new treatment can be and improve clinical trial recruitment efforts.
Looking at Things from the Patient’s Perspective
The reality is that only a small minority of clinical research professionals have ever participated in a study themselves. Not having that experience can make it much harder to fully understand a volunteer’s personal experience.
Advocates like the late Jess Jacobs made waves in the medical community thanks to their strong stance on modern patient care. Jess was very transparent about what she called “not my problem” healthcare and the issues this causes for patients living with rare diseases like hers. She believed that healthcare could be significantly improved if the patient’s viewpoint was given more weight.
The same can be said for clinical trials, too. So, here are some of the things that clinical trial participants have been asking for:
Improving the Informed Consent Process
Not long ago, CISCRP ran a story about Alicia Pouncey. She’s a research professional who learned first-hand what is most important for patients when participating in a clinical trial. A major point of concern for her was the informed consent process.
“The informed consent process runs counter to the way many people are socialized,” Alicia says. “It is so inconsistent with how we are normally treated when we visit a doctor.”
Less than 5 percent of oncology patients ever end up taking part in a clinical trial. Information overload could play a significant role here. Imagine that you’ve just been diagnosed with terminal cancer. Now imagine trying to comprehend a 25-page document filled with difficult-to-understand jargon shortly after. Then you are disqualified for eligibility criteria completely out of your control.
In light of those prospects, it’s not hard to see why many give up on joining an oncology study. Fortunately, we are seeing an evolution in electronic informed consent or eConsent forms. These promise to address many of the issues that patients have with the traditional informed consent process.
Taking into Account Patient Reported Outcomes (PROs)
In a compelling TED Talk, ePatient Dave talked about his experience dealing with stage 4 lung cancer. He remarked that patients remain one of the most valuable untapped resources in health care.
In recent years, more organizations have begun to see the value in patient-reported outcomes (PROs). Essentially, this assessment shows what patients thought about the treatment and study and isn’t influenced or amended by anyone on the research team.
In order to ensure PROs are standardized, research teams need to develop detailed patient questionnaires. These questions should focus on gathering information about how the study affected patients physically, emotionally and even socially.
Research teams can then score these responses and pair them with their own quantifiable benchmarks to more accurately judge the success of the investigative treatment and clinical study.
Patient centricity is something that many of us are concerned about. So how can we make our studies more patient centric? Listening to patients is an essential step!
Moving forward, involving patient advocates (like ePatient Dave) could provide significant benefits. They would help ensure that the goals of the participants aren’t forgotten and could offer recommendations on how to make trial designs more patient friendly.
In our modern world, people are demanding more transparency from organizations. This is an area where our industry has had issues. People still tend to distrust clinical research, especially if there’s a lack of available information about it.
Working with patient advocates can help our industry become more transparent and gain credibility with new patient populations.
Welcome to Clinical Research Trends, a new blog dedicated to providing breaking news on clinical trial recruitment, patient engagement, new technology and noteworthy trends. With this blog, we are working to provide clinical research organizations, sponsors and leading service providers with critical news and industry updates on a regular basis. If you want to learn more about the latest trends in clinical trial recruitment and drug development, you’ve come to the right place.