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Recent study, and others in literature, inform misconceptions around physician and nurse involvement in clinical trials.
For more than two decades, the widely and frequently quoted statistic that only 3% to 5% of eligible patients participate in oncology clinical trials has served as unequivocal proof that the clinical research enterprise is failing to attract a reasonable level of patient participation. And the statistic has been a rallying cry for the cancer research community-and the broader clinical research community-to study and address the
barriers to participation.
A number of factors that hinder patient participation have been discussed extensively in the literature, including: limited public and patient awareness and literacy; mixed patient attitudes and perceptions about clinical research; complex clinical trial designs with stringent eligibility criteria; inconsistent and poorly executed study recruitment strategies, planning, and tactics-particularly when competing with other actively enrolling clinical trials; and poor healthcare provider-both physician and nurse-familiarity with, and access to, clinical trials, combined with limited interest in referring patients.
A growing body of research calls to question the role of healthcare providers and suggests that this barrier is more nuanced and mischaracterized. Research suggests that healthcare providers possess a unique relationship with study volunteers that is untapped and holds the key to facilitating patient engagement. As clinical research and clinical care converge, healthcare providers will likely be the linchpin to engaging patients as clinical research partners.
A mission critical role
Healthcare providers play an essential role advising, guiding, and influencing patient participation in clinical research. Studies have consistently demonstrated during the past two decades that doctors and nurses are among the most trusted sources for health and medical information, including clinical trials. A recent CISCRP study found that the majority of patients (84%) state that they would consider participating in clinical trials if their physician recommended that they do so. And a high percentage (71%) of global study volunteers confirms that they spoke with their physician prior to making the decision to participate in a clinical trial.
Studies also indicate that patients who receive information about clinical trials from their healthcare provider are significantly more likely to participate. And patients who engage in frequent quality interactions with, and who receive an offer to enroll in a clinical trial from, their healthcare providers are also significantly more willing to participate.
To add to this body of knowledge, the Tufts Center for the Study of Drug Development (CSDD) recently conducted a study among physicians and nurses actively caring for patients across multiple disease conditions. Online surveys-one for nurses and one for physicians-were designed based on questionnaires from past scholarly assessments and on input from medical and clinical research professionals.
The surveys included questions about professional training, familiarity with and exposure to clinical trials; general attitudes and perceptions about clinical trials; comfort level and confidence referring patients into clinical trials; barriers to referring patients; clinical practice setting characteristics (e.g., type and size of practice and weekly patient volume); and background demographics.
The surveys were conducted in late 2015 and early 2016 and received 755 and 1,255 completed responses from physicians and nurses, respectively. Respondent race and ethnicity, gender, and disease specialty are representative of their respective populations.
Approximately half (48%) of physician respondents were female, with two-thirds Caucasian, 18% Asian, 10% Hispanic/Latino and 5% African American. The respondent sample was widely distributed across disease specialties. Top physician specialties included 35% internal/family medicine and 16% neurology and psychiatry.
Nurse respondents were predominantly female (85%) and Caucasian (82%) with wide distribution across disease areas of focus. Top disease specialties included cardiovascular (14%) and neurologic (10%) diseases. Only 2% reported focusing on oncology.
The majority of respondents (80%) from both surveys are based in North America and the remainder from Northern and Western Europe.
Familiarity and perceptions
Between 40% and 50% of physicians and nurses report being exposed to clinical research in medical and nursing school, and similar percentages have participated as clinical investigators or as research coordinators. A substantially smaller percentage-20% of physicians and 16% of nurses-have participated in clinical trials as study subjects/volunteers.
Nearly nine out of 10 physicians (88%) and seven out of 10 nurses (69%) report being “somewhat” and “very familiar” with the clinical trial process. Moreover, 86% of physicians and 69% of nurses, respectively, feel “somewhat” or “very comfortable” providing clinical trial information to their patients. An even higher percentage-91% of physicians and 72% of nurses-report that they feel “somewhat” or “very comfortable” discussing clinical trial opportunities with their patients.
Seven out of 10 physicians (71%) and nurses (69%) say they view clinical trials as a healthcare option for their patients. Forty-two percent of physicians and 43% of nurses indicate that their patients are inquiring about clinical trials more frequently than they did a few years ago.
Physician and nurse interest in referring patients into clinical trials is very high, at 72% and 69%, respectively. However, the study found wide disparity in referral rates and referral volume between nurses and physicians. Six out of ten physicians reported referring at least one patient into a clinical trial during the past year. This is significantly higher than the 17% of nurses who reported doing so (P<.005).
Physicians report referring a median of five patients into clinical trials annually, a referral rate that is less than 0.2% of their annual clinical care patient volume. Nurse referral volume is considerably lower-a median of two patients annually-representing a .04% referral rate.
Eight out of 10 physicians (80%) and two-thirds of nurses (68%) indicate that they are most likely to refer their patients to colleagues with whom they are familiar and to well-respected and recognized regional or national opinion leaders.
Barriers to referral
Many academic studies-primarily focusing on oncology-have assessed the barriers preventing physicians and nurses from referring and enrolling their patients in clinical trials. The strongest barriers are time-based: lack of time to gather and evaluate clinical study information and insufficient time to discuss clinical trial information with patients. Physicians and nurses also cite the lack of sufficient information about clinical trials, overly stringent eligibility criteria, and the perceived burden for their patients to participate. The weakest barrier mentioned in all studies is the fear of losing patients to the principal investigator or another specialist.
In the Tufts CSDD study, looking across multiple disease specialties, several factors appear to increase the likelihood of physicians and nurses referring patients to clinical trials: distance between the clinical practice and the research center is inversely associated with patient referral rates; and physicians more involved in patient care are less likely to refer their patients.
Physicians who have never participated in a clinical trial as an investigator are significantly less likely to refer a patient (P<.0001). And more recent graduates from medical school are significantly less likely to refer their patients into clinical trials than are older colleagues (P<.0001). European physicians are 8.5 times more likely to refer their patients than their North American peers (P<.0001).
Nurses with a Master of Science in Nursing (MSN) degree and nurse practitioners were 8.8 times and 4.5 times more likely, respectively, to refer their patients than registered nurses (P<.001). Nurses in academic medical centers and in physician practices were significantly more likely to refer than those in hospital settings (P<.0001). European nurses were 14.3 times more likely to refer their patients than their North American counterparts (P<.0001).
Among both physician and nurse cohorts, gender, race, and ethnicity were not significant predictors of referral behavior.
Necessity and opportunity
The results of the Tufts CSDD study are very consistent with those published in the literature, with some additional insights. Nearly half of healthcare providers have been exposed to clinical research training during medical and nursing school. The majority of physicians and nurses are interested in referring their patients into appropriate clinical trials; self-report feeling familiar with the clinical trial process and feeling comfortable providing clinical trial information to, and discussing clinical trial opportunities with, their patients.
The study findings indicate that a high proportion of physicians actively referred their patients into clinical trials during the past year but the reported referral volume is very low. Indeed, the referral volume is well below that dictated by clinical trial eligibility criteria alone. Low referral rates contrasted against a high comfort level and willingness to refer suggest that healthcare provider referral behaviors are more nuanced and complicated.
Most physicians and nurses want to actively advocate for their patients and provide access to the best
healthcare options available-including investigational treatments in clinical trials. Having established more intimate relationships with their patients, physicians and nurses facilitate enrollment in specific clinical trials based on their subjective assessment of each patient’s unique ability and predisposition to enroll and participate.
The Tufts CSDD study findings suggest that healthcare providers rely on the strength of their personal knowledge and their mental and physical closeness to clinical research: who is conducting the clinical trial, and where it will be performed (i.e., convenient proximity and reputation of the research center). The reasons why physicians and nurses choose not to refer patients are addressable and largely associated with the need for more information that can be conveniently and quickly reviewed and processed. Creative, compelling, easily accessible, and integrated medical and professional education programs will help address this need. Dedicated, rich-content interactive channels and communities may be important conduits. Well trained, roving clinical research education liaisons within healthcare settings may also prove effective.
The widely accepted and cited statistic on low patient participation rates overgeneralizes and mischaracterizes the enrollment challenge. The recent Tufts CSDD study-along with those in the literature-refutes long-held notions that healthcare providers are insulated from, and disinterested, in clinical research and resistant to referring their patients into clinical trials. The study results also indicate that healthcare providers are better positioned than expected as patient engagement facilitators if they have sufficient time, information, and confidence to advocate on behalf of their patients.
Ken Getz, MBA, is the Director of Sponsored Research at the Tufts CSDD and Chairman of CISCRP, both based in Boston, MA. email: email@example.com