Contrary to popular belief, the main reasons physicians are reluctant to refer patients to clinical trials have nothing to do with fear of losing them to other providers or a lack of knowledge about industry-sponsored clinical research.
A new Tufts Center for the Study of Drug Development (CSDD) study found that healthcare providers (HCPs) have a higher-than-expected level of familiarity with clinical research and willingness to refer patients into trials. A significant majority of physicians also reported they are often the primary source of information about clinical trials for their patients and that they actively support their patients’ participation in research.
Patient referral rates remain low, the study found, since physicians often are not familiar with the principal investigators (PIs) and sites conducting research in their community or because they haven’t had the time to understand the protocol at a level where they would be comfortable referring patients into the trial.
Significantly, the Tufts CSDD analysis suggested that the more actively involved a physician or nurse was in their patient’s care, the less likely they were to make a referral because they used criteria other than the protocol’s inclusion/exclusion requirements to determine whether their patient was appropriate for the trial.
“We take eligibility at face value, but what we don’t understand or acknowledge is that the physician and the nurse are integral to the patient’s experience. Most are clearly putting thought into which patients would be appropriate to actively refer. The recommendation has to do with their intimate knowledge of the patient as a person and the care that the patient receives,” said Ken Getz, director of sponsored research programs and associate professor, Tufts CSDD, Tufts University School of Medicine. “We shouldn’t treat the physician or nurse as a hindrance. We have to engage them as a partner in the process.”
The Tufts CSDD study highlights the critical role that HCP involvement plays in supporting patient engagement in clinical trials, an area not often discussed, and offers opportunities for finding ways of more actively engaging physicians and nurses in the research process.
Importance of research
Tufts CSDD conducted an online survey between May and August 2015 of 755 physicians and 1,255 nurses from both community-based practices and hospitals worldwide about the level of their involvement in clinical research.
Many studies published on the subject have found that HCPs are an integral part of helping patients consider and ultimately choose to participate in clinical research. Patients view their physicians and nurses as a trusted source for clinical trial information. However, there has been little research about the level of engagement of practicing physicians and nurses in clinical research.
“This is an area we don’t understand very well,” said Getz, also founder and board chair of Center for Information and Study on Clinical Research Participation (CISCRP). “Most of what we know about practicing physician involvement in clinical research comes from the cancer community. We’ve rarely seen data that helps us understand physicians in other therapeutic areas.”
The Tufts CSDD study found that physicians and nurses have a high level of knowledge about clinical trials and actively support their patients’ participation in studies. A significant majority of physicians (88%) and nurses (69%) said they were familiar with clinical trials and were comfortable providing clinical trial information to their patients. Physicians indicated they know how to find trials that are being conducted in their community and 41% said they have conducted online searches on behalf of their patients. In addition, 72% of physicians and 69% of nurses said they were interested in referring patients to clinical trials in the future.
Almost half of physicians said they were most likely to make a clinical trial referral when no other treatment options were available (49%) and when they were confident in the PI or site conducting the study (38%). Physicians and nurses who had previously participated in a clinical trial were more likely to refer patients, according to study results, and HCPs referred patients at a higher rate if the investigative site conducting the study was close in proximity.
“The issue isn’t getting HCPs aligned with the importance of clinical research. They already buy into this or they wouldn’t have gone into healthcare. In fact, many have said to us that they see clinical research as part of the ‘duty’ of being a healthcare professional,” said Elisa Cascade, president of Data Solutions at DrugDev.
Although 60% of physicians said they had referred patients to clinical trials, actual referral rates were very low. Physicians reported referring a median of five patients a year, which represents less than 1% of the patients they serve, while nurses referred a median number of two patients annually.
While 63% of nurses said they were comfortable discussing information about clinical research with their patients, only 17% had actually referred a patient to a clinical trial. In open-ended responses, nurses indicated that they consider it the physician’s responsibility to discuss the possibility of clinical trial participation with patients.
The top barriers for physician referrals related to a lack of time and information to make a confident recommendation. More than half of physicians (54%) said they lacked access to information and about a third said they didn’t have enough time to learn about studies or discuss them with their patients. Almost half of both physicians and nurses (48%) mentioned not knowing where to refer patients. The weakest barrier to referrals from both physicians (9%) and nurses (2%) was fear of losing patients to the clinical trial practice.
“Physicians don’t have to be the protocol expert, but they have to understand the goals, the likelihood of the patient getting placebo and the top-level inclusion/exclusion criteria. They don’t have to read the fine print—they can let the study coordinator make that determination. But they need to have an understanding,” said Stewart H. Rosen, M.D., vice president of Medical Affairs, Quintiles Health Management Solutions.
Disconnect in defining eligibility
Another key barrier to physician referrals identified by the Tufts CSDD study involves a disconnect between the face-value eligibility requirements for a clinical trial, which are defined strictly by the protocol’s inclusion/exclusion criteria, and how HCPs assess whether they believe a patient is appropriate for a study. HCP referrals typically take into account the relevance of the study goals, potential benefits of the investigational treatment, proximity to the research center and whether they believe the patient can handle the demands of the clinical trial.
These findings raise questions about whether widely quoted statistics on the low-levels of eligible patients who participate in clinical trials should be accepted at face value. The National Cancer Institute has stated that only 3% of patients who meet a study’s eligibility criteria participate in cancer research; other researchers have expanded that eligibility statistic to include major diseases such as some chronic conditions, and the number is now close to 7%.
“Eligibility has to include the participant’s personal ability to be a volunteer in a trial. The physician and nurse communities are closer to their patient and understand their needs better than just about anybody else,” said Getz. “There are many dimensions of eligibility that go well beyond the protocol. We erroneously viewed the physician and the nurse as bottlenecks when it’s more appropriate to think of them as facilitators.”
Understanding the disconnect between face-value eligibility and HCP-assessed eligibility, along with the dynamic that exists between physicians and their patients, will be critical as the industry looks to more actively engage physicians and nurses in clinical research.
Building physician referral networks
A few companies and investigative sites actively manage their relationships with local physicians by building referral networks that take into account the importance of HCP-patient relationships in recruitment strategies.
Compass Research, which operates three research sites in central Florida, has established partnerships with 45 community physician practices to spread awareness about clinical trial opportunities and refer eligible patients. The medical practices range from small neurology specialties to multi-group primary care networks with access to tens of thousands of patients.
“If awareness about a clinical trial comes from the primary-care or treating physician to the patient, you see a trust level that is significantly higher than what you see going direct-to-consumer. Patients seem to engage much faster,” said Sean Stanton, CEO of Compass Research.
The company signs contracts and non-disclosure agreements to protect the confidentiality of patient health information. Startup meetings are held with physicians to review protocols and patient inclusion/exclusion criteria. As part of the agreements, physician practices are assigned a research liaison to help with chart review, answer questions about the study, remind HCPs about speaking to patients about clinical research opportunities and, importantly, provide the physicians medical updates about their patients enrolled in clinical trials. Liaisons at the physician’s office also help pre-identify potential subjects through EMR databases and are available after physician appointments to speak with patients interested in clinical trial participation.
“They are busy with their practice and research is not typically what they are doing. For [the relationship] to be successful, we need a person dedicated to the practice who can provide them with information. Their personality and fit with the practice is critical,” said Stanton. “The liaison helps bridge the practice to research.”
Quintiles has developed HCP-referral networks globally through a program that deploys field-based Clinical Trial Educators (CTEs) to support patient recruitment initiatives for a specific protocol or investigational drug. Activities include identifying where patients who meet the protocol requirements are first seen in the community and educating HCPs in those hospital departments and physician practices about the study opportunity.
CTEs establish referral networks by visiting local HCPs on behalf of the investigative site, sharing information about the study and type of patient who could benefit, and creating a process that makes it simple for treating HCPs to refer patients to the clinical trial. CTEs help organizations create a system to query their electronic medical records (EMR) for potential subjects and return to the network sites frequently to remind HCPs about key protocol points and discuss research opportunities when patients present with the disease being studied. The CTEs also work directly with the investigative site to identify and address barriers to recruitment through ongoing site training and education.
“We are a resource for investigative sites that don’t have the bandwidth to educate and drive a referral network. The healthcare providers are very willing to get involved in clinical trials and the referral network is there. But no one has the time to educate them. That is the biggest gap,” said Quintiles’ Rosen. “We have been highly successful in educating the HCP community. It closes the gap and allows those potential HCPs to refer.”
Quintiles, which employs more than 900 clinical educators across 20 therapeutic areas, has found through internal evaluations that 40% of patients randomized for a study that uses CTEs are enrolled within 10 days of a CTE site visit. This result illustrates the positive impact on enrollment of CTE site visits, a pattern which is seen in CTE programs across all therapeutic areas.
“The clinical trial educators try to keep the trial top-of-mind for healthcare providers, who often work in very busy offices or sites. We want to keep our protocol opportunity in front of that referring network,” said Rosen. “Ultimately, the overall remit is to speed-up the trial and enroll patients.”
In another example, PPD, which develops relationships with high-performing sites through its PPD Select program, helps investigators identify other local physicians with patient populations who might qualify for a particular study and provides resources to reach out to those HCPs about the research opportunity.
“The investigator running the study may send a note to colleagues within a geographic range asking if they have patients that meet the therapeutic area. They try to be fairly specific without being exhaustive on the detail,” said Stephen Powell, executive director, Strategic Feasibility, Site Intelligence and Activation (SIA) Group, PPD. “The treating physician pre-selects patients that are best qualified for the study and the referral is like any other medical referral. The referring physician is kept aware of the status of the patient so it’s not an issue of the referring physician losing said patient. The referral is for research purposes only and medical treatment is still the domain of the referring physician. They are basically just making the research available to the patient.”
Building a stronger foundation
As the industry moves toward a more patient-centered drug development model, the Tufts CSDD study highlights the importance of expanding the definition of patient-centricity to include the physician or HCP as part of the patient’s support network and building a stronger foundation for engaging physicians in the research process.
The early findings, which Tufts CSDD researchers are in the process of evaluating, suggest that the research community needs to rethink the role of the HCP as a facilitator and find ways to help them become more effective and informed partners in clinical research. For example, Getz said educational efforts could be geared toward helping physicians evaluate clinical trial opportunities and make more informed assessments about a patient’s capability of being a study volunteer. Other educational efforts could focus on developing outreach and educational programs for nurses, which the Tufts study identified as a critical untapped resource for improving HCP engagement in clinical research.
Creating a higher comfort level between community physicians and the investigative site landscape could be another important area for improvement, according to the Tufts analysis, since physicians reported they were less likely to refer patients to a study when they didn’t know the PI or the study site. CISCRP, for example, has organized events that introduce practicing physicians to PIs in their community, which have resulted in increased physician referral rates to clinical trials.
“Often, practicing physicians and nurses are in insular communities and are reluctant to refer outside of their own system, even though it might be what is best for the patient,” said Getz. “Reducing the sense of distance between the healthcare provider and the clinical research community can be very helpful.”
Efforts to improve physician engagement also need to make clinical research information more accessible to the HCP community, especially given all of the other information that physicians and nurses are inundated with each day, and make it easy to make referrals. As the industry moves toward greater integration of clinical research and healthcare systems, many see increasing opportunities for using EMR as a way to engage practicing physicians in research and and push study information to the point-of-care.
The Research Institute of Deaconess Clinic, which has access to one of the largest multi-specialty physician networks in Indiana through its affiliation with Deaconess Clinic, already has added research functions to its EMR system that make it easier for treating physicians to identify and refer patients to actively enrolling trials. The first study conducted with the enhanced EMR research functionality led to 157 patient referrals from 34 physicians across the organization, tripling the expected enrollment. Since then, the average enrollment rate across all clinical trials is 122%, up from 72% just 18 months ago.
The EMR system allows investigators to expedite the pre-identification of patients who meet the study’s inclusion/exclusion criteria. The clinic’s treating physicians are then given the opportunity to review a list of their patients who potentially are eligible for the study. Physicians who feel their patients may benefit can review study information and ask that the EMR system remind them about discussing research opportunities with their patients. A column is added to the physicians’ daily appointment schedules within the EMR to flag patients pre-identified as potential study subjects. Physicians can also be given a targeted patient list each morning to help them prepare for talking with potentially eligible study participants throughout their practice day.
Investigators and treating physicians can directly refer their patients to the recruitment staff electronically through the EMR’s new research functions, similar to the process used for making a specialty or ancillary referral, which replaces the need to submit clinical trial referrals on paper.
“After you educate physicians about a treatment option available to their patients through a new clinical trial, you have to take a look at how easy it’s going to be for them to refer. These doctors are busy. If we help them better understand the science driving the development of a new treatment and give them the opportunity to present the treatment and study to their patients, we also need to make it easy for them to refer,” said Gregory A. Folz, administrative director, Research Institute of Deaconess Clinic in Evansville, Indiana.
There is widespread agreement about the need to better engage physicians and other HCPs in the clinical research process, particularly as the industry adopts patient-centric drug development models. The Tufts CSDD study highlights the critical role that HCP involvement plays in patient engagement and offers insights into how to better leverage the involvement of physicians and nurses as facilitators in clinical research going forward.
“When we think about patient-centric clinical trials, we can’t remove the healthcare provider from that equation,” said Getz. “We have to actively find ways to engage them as facilitators in the process.”
Karyn Korieth has been covering the clinical trials industry for CenterWatch since 2003. Her 30-year journalism career includes work in local news, the healthcare industry and national magazines. Karyn holds a Master’s of Science degree from the Columbia University Graduate School of Journalism. Email firstname.lastname@example.org.
This article was reprinted from Volume 23, Issue 06, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>