Helping researchers with a tough topic

Phase 1 recruitment — essential points, pitfalls

Recruiting patients for Phase I oncology studies — which are unlikely to provide therapeutic benefit to participants and which carry the risk of significant side effects — raises unique issues in informed consent.

Patients who are recruited for such studies often have late-stage cancers that have not responded to previous treatments. Although the purpose of Phase I studies is to see if an experimental medication is safe and to establish dosages, studies have shown that patients often have unrealistic hopes for the drug's effectiveness against their illnesses.

Trying to recruit patients without producing this therapeutic misconception can be difficult for clinicians, says Richard Brown, PhD, an assistant professor in the department of social and behavioral health at Virginia Commonwealth University School of Medicine in Richmond.

"We know that clinicians commonly rate clinical trial discussions as one of their hardest communications challenges," Brown says. "This is in part because they have to go from being an expert, with an evidence base for the treatment, to being something of a salesperson, having to sell something without that evidence they can use to back up their recommendations."

"There are particular communication issues that arise in Phase I studies because of when they are conducted and the likelihood of benefit for patients. It's a tricky, challenging area and it's one that's been under-studied."

Analyzing consultations

Because of evidence describing poor communication during informed consent discussions, Brown and his colleagues examined a series of consultations in which patients were recruited to Phase I oncology trials. They looked for the types of information being presented, how the information was presented and the strategy for decision-making used.

Results from the study were published in the journal Psycho-Oncology.1

Brown says the goal is to develop communications strategies to help clinicians and patients in these types of discussions.

"It seems to me that one of the ways forward with this is for clinicians to understand the challenges and to be given support and suggestions for ways they can address these kinds of issues in more helpful ways," Brown says.

Brown's group recorded and analyzed conversations between six oncologists and 16 patients regarding Phase I trials. They identified six communication themes that arose during these conversations:

— Orienting, in which the physician and patient reach agreement about the diagnosis and extent of the patient's disease. The physician may talk about various other treatments and rule them out as options.

— Educating the patient about Phase I studies in general and a specific study or studies for which the patient may be eligible. The doctor will discuss how the experimental treatment is supposed to work in the body as well as concepts such as dose escalation.

— Describing uncertainty, explaining the rationale for the study, such as providing knowledge to help future cancer patients, as well as noting the possibility of benefit to the patient or side effects.

— Persuading, in which the physician uses one or more strategies to convince the patient to participate. These might include expressing optimism about the trial or urgency to sign up (by saying, for example, that there are limited openings for participants).

— Decision-making, in which the physician and patient come together to make a decision about the trial.

Not all of the themes identified in the study were present in all of the discussions, Brown says. In the recommendations, the group actually looked at ways to avoid some of the persuasive techniques identified.

Shared decision-making

Brown says that "shared decision-making," with the physician and patient contributing equally to the final decision, is considered the gold standard for clinical trial communications. But he says that's not always what every patient wants.

"The literature shows that some patients prefer shared decision-making," he says. "On the other hand, some patients really want to make the decision themselves while taking into account the physician's recommendation. And at the other end of the spectrum, some patients just want to give the decision to the clinician and say, 'You tell me what you want to do.'"

He says physicians should determine how the patient prefers handling the decision, and check back with him or her frequently to make sure that preference doesn't change as the situation changes.

Likewise, Brown says clinicians should understand how much information patients want to know — about the trial, about potential side effects, about their prognosis — and tailor the consultation to the needs of the patient, checking back periodically to make sure preferences haven't changed.


  1. Brown R, et al. Seeking informed consent to Phase I cancer clinical trials: Identifying oncologists' communication strategies. Psychooncology 2010 Apr 7 (Epub).