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Reservations Held by Referring Physicians in Clinical Trials
Some physicians are reluctant to participate in clinical trials as a referring physician. This is a huge issue because a large portion of participants can come directly from a referring physician’s office.
Referring physicians hesitate to get involved in research for several reasons. One of the main reasons is that they may be afraid they will lose their patients to the investigator physician who will be giving them medical attention during the study. Many physicians who are not regularly involved in clinical research don’t fully understand the importance of the specific research being done and therefore don’t care to promote it (similar to any other member of the research team). Finally, referring physicians, especially PCPs, do not have clinical research on their radar; general awareness of research is lacking because it does not command their attention as much as their other tasks.
Seeking solutions for these issues, we spoke with Christina Norris, VP of Clinical Operations at Benchworks and specialist in planning, developing and executing patient recruitment programs for clinical trials.
To quell any fears of losing patients, Norris says that PI’s need to leverage existing relationships and create a level of trust with their peers in healthcare. “Referring physicians can have a large impact on patient enrollment, and we [investigators] must ensue trust and a sense of camaraderie to eliminate any fears a referring physician may have about losing their patients if they refer them into a clinical trial.”
PI’s also need to make sure the research participants know that they should continue seeing their PCP even during the study. “Investigators hold the responsibility of making sure patients know that they are getting additional care while in the study, not replacement care.”
Explaining the Why
Understanding the end goal is also quite important in this situation, Norris says. It’s easy to get overly wrapped up in the business or academic nature of clinical trials. Many physicians can forget that the ultimate goal of any clinical trial is to find new ways to help patients. “Improving patient recruitment processes is a key factor in avoiding costly delays in bringing new drugs to market.” Physicians can feel more motivated to participate in a trial when they are reminded that the trial is a key part of bringing new therapies to market, which will help their patients in the long term.
Inadequate exposure is another reason recruitment fails; research teams must make sure the referring physicians know about trials and are reminded about them just as much as the investigator physicians. “Make sure referring physicians are copied on all the emails. Keep them in the loop so they are reminded that they are part of the team.”
Fostering awareness has a lot to do with strategic advertising. Alex Mouravskiy, Biorasi’s Chief Marketing Officer, offers additional advice on getting the word out: “It’s important to remember that while drug trial registries exist, they aren’t terribly easy to use or intuitive. Moreover, many practicing physicians aren’t aware of their existence, and most certainly don’t check them regularly. Promoting the availability of your trials is your responsibility, and it goes beyond relying on investigators to find patients. Setting up lunch and learns or dinner roundtables for your investigators and a pool of potential referring physicians is a fantastic tactic to get the word out about your trial and has worked extremely well for Biorasi in the past on difficult-to-recruit trials.”
The Big Picture
In addition to the specific solutions above, Norris also helped us to understand the larger scope of referring physicians’ reservations and related issues to trial recruitment. “Compassion and education are important elements here. You [the recruiter] are not steering patients into research but allowing them to make an informed decision with their healthcare providers.” This might be one of the biggest decisions a patient, along with their PCP, makes in their entire life.
An extra piece of advice Norris gave us has to do with the point of contact between the referring physician/patient and the clinical trial sponsor/CRO, a frequently underprioritized factor. Sometimes, a CRA is enlisted to recruit patients for a study. “Remember that, above all, CRAs are the face of the CRO/sponsor to the site, so they are responsible for maintaining a good relationship. Many CRAs are new to the job, and it’s asking a lot of them to be responsible for patient recruitment on top of their other roles.” Norris says that her “ideal approach to assisting sites with patient recruitment is having a dedicated, specialized person to assist sites with recruitment, not a busy, newly-hired CRA, not a nurse or physician, but a site recruitment liaison.” Another option, she says, is to require CRAs to go through additional training for recruiting. “Recruitment really requires ‘soft skills’ such as conflict resolution.”
PCPs and referring physicians can be a powerful force for recruitment if they’re approached correctly and educated on the process of the research and its benefits. Biorasi understands how to reach them and gets assistance from companies like Benchworks when needed.