Lauren Walter

Patient awareness and recruitment is an ongoing issue in conducting effective and efficient clinical trials. One barrier to patient recruitment is the “in-office” communication between physicians and patients around clinical trials as treatment options. This communication does not always occur simply at one office visit, but is an ongoing process, often involving multiple conversations over time. Past research has largely focused on the specific interaction in which informed consent is established for a particular trial and the patient is invited to participate, usually after the patient has been identified as eligible for the trial in question. This study looks at in-office conversations earlier in the patient journey toward a clinical trial, before suitable trial options have been identified or patient eligibility for a study has been established. These early conversations set the stage for patients’ understanding of and receptivity toward enrolling in a clinical trial in the future. 

	Thirty six of this type of in-office dialogues were selected and analyzed to understand what information is presented at initial discussions of clinical trials and how that information is presented. Conversations were recorded in the U.S. by 18 physicians from a variety of specialties between February 2010 and September

 2016 (see Table 1). Conversation analysis of the audio recordings and transcripts was used to identify conversational factors that may impact patients’ attitudes and understanding concerning clinical trials. Topic placement of the clinical trial and standard treatments was found to be at play in such a way as to de-emphasize clinical trials as a treatment option. The quantity of information provided around clinical trials was also found to be much less than the information provided around standard treatments. The impact that both of these may have on patients’ perception of clinical trials is discussed.

	 As former Vice President Joe Biden once stated about oncology trials, “Less than 5% of cancer patients enroll in a clinical trial, often because patients and doctors don’t know what trials are available.”

 For development efforts in cancer and other disease areas, many clinical trials are terminated early due to insufficient accrual,

 thus delaying the availability of new treatments to patients and affecting care.

 A key moment in the enrollment process is the discussion of potential clinical trials between a patient and his or her physician.

 Studies have shown that patients prefer to receive clinical trial information from their primary and/or specialty physicians; however, a relatively small percentage of patients receive information from these sources.

 Physicians report that clinical trials are one of the most difficult topics for them to discuss with patients, and they are not provided with sufficient training in communication practices to become more comfortable with this conversation and conduct it effectively.

	Research has also found that physicians having the clinical trial conversation alone is not enough-the quality of the conversation that occurs is essential to building patients’ understanding of clinical trials as a treatment option.

 This understanding is vital to the process of shared decision-making and can increase the likelihood of a patient’s participation in a clinical study.

	A clinical trial conversation between a patient and physician can take many forms, and be discussed over a number of visits. Several past studies have researched dialogues between physicians who are actively recruiting for clinical trials and patients who generally have been identified as eligible for the trial in question.

 However, patients often have one or more preliminary discussions with healthcare professionals (HCPs) regarding clinical trials before making the final decision about whether to enroll in a specific clinical trial or not. These discussions set the stage for patients’ understanding of and receptivity toward a clinical trial, yet little research has been done on conversations earlier in the enrollment process, before the moment of establishing full informed consent for a particular trial. 

	The analysis of the 36 in-office dialogues identifies conversational factors that may influence patients’ decisions regarding whether to move forward with clinical trial enrollment or not. 

	Audio recordings and transcripts of dialogues between physicians and patients were selected for analysis from Verilogue Inc.’s proprietary database of in-office medical conversations. Verilogue is an ethnographic market research organization that contracts with physicians across a variety of specialties to record natural in-office conversations with their patients who agree to participate in the research by providing verbal and written consent. Recordings are made on a digital recording device or a smartphone application and are uploaded to a secure server where they are scrubbed of all identifiable information, in accordance with the 

Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy rule. De-identified recordings are transcribed and stored in Verilogue’s database, which currently contains over 100,000 recordings dating from 2006 to 2017. This research consists of analysis of dialogues that already existed in the database prior to commencement of the research, so physicians and patients were not made aware that the focus of the research was clinical trial recruitment, and participants were not instructed to discuss clinical studies.

	Dialogues considered for inclusion in this research were limited to those in which the participants were English-speaking adults (18 years of age or older). Keyword searches were used to identify potentially relevant dialogues out of the database. Thirty six dialogues were selected for analysis based on their relevance to the topics being explored (see Table 2). The sample size is acceptable for qualitative analysis of highly structured cultural practices such as medical consultations.

 Thirty six unique patients participated, and a caregiver was present in 16 dialogues. 

	All dialogues in the sample included a physician-initiated discussion of a clinical trial as a treatment option for the patient. This research sample included discussions along a range of moments on the journey toward clinical trial enrollment, including the first mention of a trial as an option; to the decision to search for an available study if a patient is interested; to deciding whether to screen a patient once a possible trial has been identified; to deciding whether to enroll once trial eligibility has been established. A subset of 20 dialogues in the sample involved a patient decision about whether to move forward with clinical trials as a treatment option prior to determining the patient’s eligibility for the trial in question; that is, the patient agreeing to discuss clinical studies with the physician again at the next visit, or the patient agreeing to be screened for eligibility, in which case the physician would provide more details of the trial if the patient is determined to be eligible.

	Conversation analysis and discourse analysis were used to understand the relational and transactional communication dynamics, rhetorical styles, and the presentation of treatment options including clinical trials, in order to identify conversational factors that may impact a patient’s decision to move forward with the steps toward clinical trial enrollment, or not.

	How physicians conversationally prioritize clinical trials relative to other treatment options can influence a patient’s acceptance or non-acceptance of a trial offer. When physicians deprioritize clinical studies through topic placement and quantity of information, patients may choose not to participate.

 has found that topic placement and the sequencing of information are important when physicians present clinical trials as one of multiple treatment options to patients. Topic placement can be used as a persuasive strategy in medical encounters, in that the strategic structuring of information results in the conversational focus being placed on whichever treatment option is discussed last by the physician. The present study has found that, in dialogues where the patient expressed a desire not to move forward with considering a clinical trial, discussion of other treatment options was placed after the clinical trial was mentioned, thus deprioritizing trials as a topic for discussion. Conversely, clinical trials were often discussed last in a series of treatment options in the discussions where patients did choose to move forward with considering a clinical trial. 

	It is likely that physicians do not realize the impact that topic placement has during the in-office discussion of treatment options.

Greater awareness may help physicians structure their conversations with patients more deliberately. If a physician believes for medical reasons that a patient should consider participating in a clinical trial, then placing clinical studies last within the discussion of various treatment options can facilitate that conversation. However, this has been described as potentially an exercise of undue influence in the clinical trials discussion,

 so it may be beneficial for the physician also to tell the patient explicitly at this point in the conversation that joining the trial is his or her recommendation and why. This would ensure that the physician’s position is clearly communicated and not just subtly communicated,

and the patient can take this information into account during the treatment selection process.

 The amount of time that physicians have in-office with their patients is limited: the average length of a dialogue in Verilogue’s database is only nine minutes. Therefore, the amount of information that can be exchanged is also limited. By providing more information around certain treatment options over others, physicians demonstrate their priorities within the conversation. Previous studies

 of conversations later in the patient journey toward a clinical trial have found that more information is provided around clinical trials than standard treatment options, and that provision of more information is associated with increased patient accrual to a trial. The present study of conversations earlier in the patient journey shows that physicians often discuss fewer topics around clinical trials and cover those topics with less specificity than other treatment options, in spite of the complexity of clinical trials and the importance of helping the patient understand them in order to establish informed consent.

	In many cases within this sample, the only details that physicians provide around a clinical trial are the geographic location in which it would be administered and by what physician, with a focus on the logistics and potential burden of transportation. However, when approved treatment options are discussed in the same

 conversation, physicians provide much more detail, such as efficacy, mechanism of action, route of administration, and side effects, in addition to cost and logistics. To a certain extent, this discrepancy may be difficult to avoid at an early point in the patient journey, because these conversations occur before a specific trial has been identified for discussion, so the details are unknown. Moreover, the HCPs who have these initial conversations with patients often are not directly involved in conducting the trial, so they may not be familiar enough with the details to provide that information to patients. However, physicians do not point out this fact to patients and only inconsistently let them know where further information will be available should the patient choose to move forward with considering a clinical trial. 

	The quantity of information provided around clinical trials also has an impact on the potential for shared decision-making and informed consent. Physicians in these dialogues invite patients to be involved in the treatment decision and may leave the decision entirely to the patient. However, they do not always provide enough information for patients to make the best choice for themselves. By providing more details around other non-trial options and spending more time discussing standard treatments, physicians create an unbalanced treatment discussion and may give the patient the impression that the physician favors options other than the clinical trial.

	The example in Table 3 below (click to enlarge) demonstrates each of these strategies of conversationally emphasizing other treatment options over clinical trials in a dialogue between an oncologist, a non-Hodgkin’s lymphoma patient, and the patient’s caregiver.

	One possible explanation for physicians’ deprioritizing clinical trials in these treatment discussions is that physicians are sensitive to the ethically charged nature of recruiting a patient to a clinical trial. The importance of informed consent has been a major topic in the field for several years,

 and conversational strategies that may be merely persuasive in other contexts have been described as coercive when used to recruit a patient to a clinical trial. Various studies have identified conversational behaviors that physicians should avoid so as not to unduly influence patients to join a clinical trial,

 so physicians are made aware of what they should not do. They often lack a practical and ethical model of what physicians can do to improve the clinical trial recruitment conversation.8 The truest ideals of informed consent and shared decision-making encourage physicians to inform patients of all the risks and benefits of the appropriate available treatments, including non-treatment, in addition to clinical trials, in order to allow for fully informed decision-making by the patient. However, various practical concerns may prevent a discussion of this much detail from taking place in many cases, including the limited amount of time physicians have to spend with each patient, as referenced earlier, and patients’ level of understanding of various medical terms and concepts, which previous research

 has shown may be limited and which could further complicate or slow down communication.

	More succinct models of ethical clinical trial recruiting conversations have been proposed, but previous studies have found that these are often not being put into practice.

 The present study confirms that none of the dialogues analyzed include a discussion based on proposed models. Physicians are likely aware of what they should not do and unsure of what they should do. Therefore, they may be so careful not to make too strong a recommendation for clinical trials that patients do not always realize they have been offered a clinical trial.

	Patients may feel inadequately prepared to make an educated treatment decision if the physician is unwilling to provide a strong recommendation for any particular treatment option, including a clinical trial. While the vast majority of patients report a preference for being given treatment options and being involved in the treatment decision process, a large sector of patients also prefer to have their physician make a treatment recommendation based on his or her medical expertise.

 Patients may benefit from a more empathetic approach from the physician, instead of an attempt at full impartiality. See the example in Table 4, which shows a dialogue between an oncologist and a newly diagnosed pancreatic cancer patient.

	By placing clinical trials early in the discussion of treatment options, by providing less information about clinical trials than other options, and by declining to give a recommendation for a treatment option based on sound medical reasons,

 physicians may inadvertently compromise the patient’s ability to make an informed decision about whether to go on a trial or not, thus unduly influencing the patient not to participate in the study.

Conclusion and directions for future research

	Increasing clinical trial awareness, enrollment, and retention is critical for the advancement of new treatments and improving patients’ lives. This paper set out to identify conversational factors that may influence a patient’s interest in and attitude toward a clinical trial, which can have a real-world impact on the eventual decision to enroll. The analysis demonstrated ineffective communication strategies being used by physicians when discussing clinical trials with patients, highlighting opportunities for improvement through 

communication skills training founded on evidence-based communication strategies.

	The research was limited in sample size and scope, because the data was originally collected for other research purposes. Future research should investigate the longitudinal tracking of a patient’s clinical trial conversation from initial discussion to enrollment, including the involvement of multiple HCPs. This research also lends itself to further studies on the communication between patients and referring physicians, as initial conversations within the exam room can be further optimized to increase patients’ understanding of a clinical trial and the probability of enrollment.

	While improving the clinical communication between doctors and patients will not solve all of the problems of trial fulfillment, it is a critical influencer within a patient’s journey from awareness to enrollment. An effective solution to improve patient enrollment in clinical trials will most likely be multi-faceted, targeting not only awareness and retention, but the communicative exchange of information between patient and physician. 

is Senior Analyst, Verilogue, Inc.; email: 

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