Referring Patients to Clinical Trials: Is It Feasible for the Busy Physician?
Every physician must at some point feel frustrated by the absence of a more effective or affordable device or diagnostic tool. There are occasions where we just wish there were a treatment with fewer side-effects, or one that was more convenient for patients. Unfortunately, new medical advances that start in basic labs typically take more than a dozen years before they are translated to something of use for those in clinical practice, given the hurdles that are currently inherent in the scientific process. As clinicians we are aware that there are always clinical trials going on to help solve some of these impasses. Yet very few physicians in clinical practice refer patients to clinical trials, even though most clinical studies have difficulty accruing human subjects.
If other clinicians are like me, I understand why this is. First, I am not typically aware of what trials are currently seeking human subjects in my community. At any one moment in time, several dozen studies are actively recruiting human subjects in San Diego County. But even when I have been aware of a study and have been given a written description of the study to hand over to potentially eligible patients, it is rare for me to have the time to find the handout and explain to my patient why I think he or she may be interested. Generally, I want patients to know I am providing information about the study for their consideration, and that I am not necessarily endorsing it. Too much to do, with too little time.
Plenty of other factors explain why clinicians rarely refer patients to research trials. Studies show that the primary reason doctors don’t refer potentially eligible patients is that they simply forget to do so (Lovato LC, 1997). I have been told by physicians that if clinical studies were designed to financially compensate practicing physicians to help recruit potential human subjects, they’d be more likely to do so. Many physicians have said that they still would not have the time, but would consider inviting research team recruiters to be present in their offices, to promote research, in selective studies. These schemes do occur for many studies, but we should not anticipate that these strategies will be affordable or feasible in most circumstances. Moreover, they raise other complications, such as conflict of interest if clinicians are compensated for recruiting. There has been some question as to whether the clinicians, or the health system for which they work, should be financially reimbursed for this effort.
Some surveys have shown that clinicians are concerned that harm can come to their patients if they become subjects in a clinical trial. Some industry-sponsored clinical trials involve medications that have no clear benefit over existing choices but are being researched to provide a new source of income for pharmaceutical companies. Physicians may fear losing patients to a university practice or other research institution once their patients start participating in clinical research at the trial site and with its doctors. Researchers may fail to share clinical information about a patient once he or she is enrolled in a trial protocol. Patients could discontinue an important medication and/or fail to follow up with their regular doctors for chronic conditions during the period they are on a trial.
Even given all these barriers, there is a role that busy physicians can play in hastening the pace that important new medical innovations come to fruition. Many physicians in practice recognize their role in the quicker translation of research into clinical innovations that are useful to us, and would deliberately choose to promote research participation to their patients if there were an easy way to do so. Here are some possibilities:
- On a case-by-case basis, when a clinician is frustrated with a patient’s poor response to available therapies, that physician can actively seek a clinical trial opportunity for the patient. The website clinicaltrials.gov is a great first start. On a search box, a physician can type in: “San Diego and Eczema” — for example — and a list of trials for that condition will appear. Details such as the inclusion and exclusion criteria and whether the study is actively recruiting are also provided. Unfortunately, the study’s description is often very technical. While this website is useful for referring doctors, it’s not often suitable for your average patient who does not have higher education in science and health.
- Staying in touch on current research in one content area is far more practical than keeping up to date on dozens of clinical studies that are actively recruiting. For example, a GI specialist or a generalist with a special interest in irritable bowel syndrome could easily be updated (through clinicaltrials.gov) on local studies in just that topic area, and refer patients to studies that appear appropriate. This not only furthers a physician’s own knowledge of progress in that field years before developments are published, but physicians may find they can develop relationships with local investigators in that field and even influence the design of research.
- Let your patients know that “research participation can be a good thing.” Many members of the general public understand the selfless good that comes from donating blood, but have never thought of clinical research participation in the same way. Posters or pamphlets in a doctor’s waiting room with messages that remind patients that all innovations in medicine are derived from scientific research may influence them to seriously consider volunteering if ever approached to do so. Physicians who do nothing more than post such messages can, over time, significantly ameliorate the problem of poor patient accrual into research studies.
- “Research Match” (www.researchmatch.org) is an NIH-funded website located at Vanderbilt University. Any member of the general public can confidentially register his or her geographic location, age, sex, and the medical information he or she wishes to share on this site. The prospective subject is then informed with an email whenever a research study becomes available that may be of interest. Investigators cannot reach a registered user until that user actively expresses an interest in a described project. Only studies approved by accredited human subjects committees are on the website. Physicians who display Research Match posters or pamphlets in their patient areas are simply allowing patients to make themselves aware when research studies are available.
- In the future, electronic health records may be linked to clinical trial alert systems so that when a certain patient profile is entered in the EHR, the physician of the patient in question receives notice that a clinical trial may be available. Studies on whether physicians find this helpful and informative, or just intrusive, are being conducted.
Investigators could arguably be doing more to help busy physicians, but they often do not know what it is they can do. Do physicians want regular contact about their patients, with their permission, who are enrolled in local studies? How often should that be? What kind of information do physicians want? And how do they want to receive it (mail, email, fax)? Do referring physicians want to be notified of study results before the study is accepted for publication? Perhaps investigators need to find ways that unpublished study results can be shared with local physicians, but that won’t jeopardize chances for publication.
If you are a physician who is interested in obtaining posters for your office, or if you are interested in offering your advice to investigators about referring your patients to research studies, we invite you to complete a survey on www.MDSurvey.ucsd.edu. We don’t know yet how to optimize the relationship between the investigator and the practicing clinician, but since our patients and society in general will benefit from expediting the development of improved therapies and devices, it’s a relationship worth working on.