Good4Patients – Dear FDA: If We Listen, They Will Tell Us

“It has been my privilege to participate in clinical research. But it has also been my burden.”

With those words, a lung cancer survivor named Linnea Olson eloquently summed up the paradox of clinical trial participation in her December 2016 keynote address to LUNGevity’s Scientific and Clinical Research Roundtable. As the FDA considers establishing a new Office of Patient Affairs, they would do well to listen to patients like Linnea—the essential partners in clinical research. At this pivotal moment, as the broader healthcare universe grinds painstakingly toward greater patient-centricity, every person who participates in the clinical research enterprise should reflect on the extent to which we truly acknowledge that, without patients, there is no clinical research.

Examining that essential truth closely may cause more than a few of us to squirm.

As Linnea puts it: “Richard Pazdur [director of the FDA’s Oncology Center of Excellence] has said, ‘People are not for clinical trials. Clinical trials are for people.’ It’s imperative that we not lose sight of why trials exist in the first place. It is not to advance the careers of researchers. It is not to keep oncologists and hospitals in business. It is not to enrich sponsors and their shareholders. Rather, it is to provide patients such as myself with an opportunity to hang onto our very dear lives.

In clinical research, patients are both the means and the end: Trials exist to advance research that will ultimately save people from disease. But it is a harsh and unavoidable truth that, often, people will die in the course of serving that goal. Arguments about informed consent aside, trial participants like Linnea sign on willingly, with no guarantees. Often, knowing that their own chances of being helped are slim, their motivation springs from the desire to help future patients.

And yet, as Linnea describes it: “The irony is, were this anything other than a clinical trial, say, a war or a sporting event, I and my fellow participants would not be fighting for our basic human rights. We would be decorated for our valor, celebrated, maybe even highly compensated. And we can’t even get our parking comped…I feel that clinical trial participants are the graduate students / Sherpas / indentured servants of the cancer world. We do the heavy lifting–it’s all guts and no glory but we can’t say no because we’ve got nowhere else to turn.”

“We do the heavy lifting–it’s all guts and no glory but we can’t say no because we’ve got nowhere else to turn.”

“Empowered” versus “Noncompliant

An Office of Patient Affairs must address evolving considerations for patient partners that track to new types of trials; for example, in molecular targeting and immunotherapy. Nowadays, trial participation is no longer a “one-off”; many patients may move from trial to trial, and it is imperative that sponsors have a mechanism to accommodate this fact for individual patients. For example, Linnea calculated her radiation exposure—70 chest CTs and 44 abdominal scans—at just one hospital over the eight years of her various treatments and trials. She subsequently opted out of her current trial’s abdominal scan requirement. After she and her physician, a principal investigator on the trial, both engaged with the sponsor to register their concerns, the chest CT protocol was amended (reduced after one year to reflect standard of care for metastatic patients), although she remained noncompliant on the abdominal CTs.

But consider—is she “noncompliant” or “empowered?” How we perceive her participation makes an enormous difference in how we acknowledge and accommodate her individual contribution.

And that, says Linnea, is the point. “I am first and foremost an individual, a human being. Participation in clinical trials does not cede my humanity, although it certainly does result in a certain loss of autonomy. And words like “compliant” and “noncompliant” only underscore that fact.”

An Office of Patient Affairs is a good idea, a necessary idea, and one that should continue to bring both the FDA and the research community into proper—and, dare we say it?—respectful alignment around this most important and meaningful of relationships.


The FDA is currently soliciting input on efforts to enhance mechanisms for patient engagement at the Agency, with responses to the docket due June 12, 2017. Rx4good will be conducting our own research with industry, patients and patient organizations for submission, in an effort to ensure that the voices of diverse patients and patient advocates—particularly those who do not typically engage with the FDA—are heard on this important issue. If you would like to help guide our research or recommend someone to participate, please email us:

(*Excerpts from the post “When Noncompliance Is Your Best Option,” from Linnea Olson’s blog, “Life and Breath, Outliving Lung Cancer.”)