Jasmine Benger

How mapping patients’ health journeys can drive a deeper understanding of their experiences and motivations

 have shown, CISCRP’s 2017 Perceptions and Insights (P&I) survey-reaching 12,427 people around the world-elucidates areas of opportunity to improve clinical trials. The results show, for example, that more than half (58%) of the public reports that they would begin a search for a clinical trial by asking their doctor, yet the majority (73%) of people mention that they never or rarely discussed clinical trials as a treatment option.

	Lengthy study visits (11%), travel time to the study site (23%), and the possibility of being placed in the placebo group (24%) continue to be challenges that study volunteers face when participating in a clinical trial. And when participation is over, 91% of patients feel it is important to receive a copy of their study results.

	The P&I data is helpful in quantitatively providing insight into 

 current patient attitudes and experiences are regarding clinical trials.

	CISCRP has begun conducting Patient Journey Workshops (PJWs) in a creative and intimate setting to begin answering the 

 behind the quantitative survey results. In these workshops, patients are given the opportunity to share their clinical trial journeys by visually recreating their intricate and personal stories. With this approach, patients with chronic illnesses can reveal how their experiences with available treatments might weigh into their decision to participate, as well as how the symptoms of their condition or additional socioeconomic factors might affect their experience with clinical trial participation.

	Furthermore, through PJWs, patients can share why a streamlined transition back to standard of care is critical, and why receiving study results is paramount once clinical trial participation is over.

	The PJW is framed by the clinical trial participation timeline (i.e., before participation, during participation, and after participation) to capture feedback from a group of patients in a chronological manner. The group of patients invited to participate can either reflect the demographics of study volunteers for a potential clinical trial, or represent a diverse group of patients with a mix of conditions and experiences, and offer insight into unique needs and preferences of a patient population along a clinical trial timeline.

	During the first part of the workshop, participants are asked to share their past experiences with clinical trials. Questions regarding which communication channels are most relevant, where patients learn about clinical trials, and why they decided to participate are asked during the “before-participation” stage, to help provide insight to the nuances of the decision-making process. As implied by the P&I survey findings, the involvement and support of a healthcare provider can be very important to patients in their decision to participate in a clinical trial. The PJW approach can help uncover why patients view their doctor as a trusted resource-they may feel their doctor is most familiar with their health status and can best help determine whether a clinical trial is the optimal option for them.

	At the “during-participation” stage, the workshop approach allows the participants to delve more deeply into experiences with study requirements and why they might be a hurdle for some. In past PJWs, CISCRP has learned that the severity of a condition and symptoms can impact a patient’s ability to complete questionnaires (hand-written ones especially, if issues with dexterity are present in the patient), to travel back and forth from the clinic, and to fast before clinic visits. This stage of the PJW has also revealed why certain socioeconomic factors make reimbursement and compensation critical, as it may be difficult for some patients to pay for travel out-of-pocket, to take time off work, or to afford childcare.

	Finally, at the “after-participation” stage, the workshop has shown that having a clear plan in place to transition back to standard of care can help patients not feel abandoned after their trial participation has ended, and that patients value receiving their study results because this can help them determine if the study drug worked for them, and see how their participation helped others.

	The sharing of the patients’ actual clinical trial experiences highlights the drawbacks of their participation, so that during the second part of the workshop, patients can use their past experiences to brainstorm the ideal clinical trial journey. Once the workshop is complete, the actual journey map is overlaid on the ideal journey map to identify areas of opportunity for the sponsor to consider.

	CISCRP’s experiences conducting Patient Journey Workshops have generated valuable and actionable insights for sponsor companies. As clinical trials become increasingly more customized to individual patient needs associated with rare and highly specialized disease conditions, there is much to learn by letting patients share their unfiltered experiences (see 

	Patient Journey Workshops differ from other methods of soliciting patient feedback, which often are more tailored to what sponsors want to learn, leaving little room for patients to share what is most important to them. By purposefully dedicating time to listen to patient stories and ideas for how to improve clinical trials, industry stakeholders can learn the underlying reasons why certain aspects of clinical trials are more important for patients than others.

	Ultimately, clinical trials will be better suited to engage each patient from start to finish.

CISCRP Research Services: Nova Getz, Annick Anderson, Jasmine Benger

Articles

How mapping patients’ health journeys can drive a deeper understanding of their experiences and motivations.

Sharing Stories of Clinical Trial Participation from Start to Finish

This article is the fourth in a series on the results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) 2017 Perceptions & Insights Study. Nearly 12,500 people worldwide responded-including the public, patients, and study volunteers-and provided valuable insights into opportunities to improve global education, outreach, and engagement. 

	Sponsors have been investing heavily in patient engagement initiatives to reduce study volunteer participation burden and improve participation experiences. Optimizing the administration of clinical trial medicines and their accompanying instructions are critical means to establishing positive volunteer experiences, better compliance, and higher retention rates. The 2017 Perceptions and Insights (P&I) Study offers insight into opportunities for sponsors to optimize clinical trial medicine kits.

	The 2017 P&I Study included 2,194 global clinical trial participants. These patients shared their experiences with different types of investigational medicines and accompanying instructions, their ability to remember to take their investigational medicine, and the support they received from site staff when asking investigational medication-related questions. Bottled medications were used most frequently by patients (23%), followed by blister packaging (15%) and pre-filled syringes (11%). The method of administration varied across regions. European patients reported the lowest use of bottled investigational medications (9%), and those from South America and Africa reported significantly higher use of topical investigational medications (17% and 19%, respectively) compared to approximately 5% in other regions.

	In aggregate, experiences with investigational medicines and medical devices were generally positive. The majority of patients felt remembering to take and administering medicines was “very easy” (74% and 76%, respectively). Instructions accompanying investigational medications were also described by most as “very easy” to understand (74%), and the majority of patients thought site staff answered medication-related questions “very well” (68%). However, areas of opportunity to improve experiences and increase compliance emerge when the methods of administration and different patient populations are examined more closely.

	Overall, investigational medicines in bottles proved to be the least challenging for patients when compared to other methods of administration. In the latest study, patients reported bottled investigational medications to be the easiest to administer (84% “very easy”) and to remember to take (80% “very easy”), followed by investigational medication in blister packets (74% “very easy” to take, 73% “very easy” to remember).

	Patients whose medicines were more involved (i.e., administered via syringe, inhaler, or topically) expressed more difficulties, and the need for increased education and instruction was additionally noted. These investigational medicines were less likely to be considered “very easy” to administer by patients (see Figure 1) perhaps because these methods are typically more complex and may cause some discomfort. These patients were also less likely to feel their medicine instructions were easy to understand (63% syringe, 62% inhaler, 59% topical “very easy” to understand) compared to patients receiving their medication in bottles (81% “very easy”).

Challenges by specific patient populations

	Difficulties specific to certain patient-subgroups also illustrate the need for increased education and support for particular populations.

	Experiences with investigational medicines generally improved with age. Those 18 to 44 years old were significantly more apt to have difficulties administering their investigational medicines (16% “somewhat/very difficult”) compared to patients 45 or older (4% “somewhat/very difficult”). Younger patients were also less likely to feel site staff answered their investigational medicine-related questions well and found instructions to be more challenging to understand compared to older patients (see Figure 2).

	Perhaps due to increased work or family commitments, younger patients additionally struggled to remember to take their medication (19% “somewhat/very difficult”) compared to older patients (3% “somewhat/very difficult”). Notably, in this most recent study, a higher proportion of younger patients stated they would have liked text messaging to have been used during their clinical trial for reminders. This may offer an innovative way to improve compliance and better engage a younger generation of trial participants.

	Level of education also impacted experiences. Among patients with a primary level of education, less than half found administration to be “very easy” (49%) compared to patients with a higher education level (75% “very easy”). A similar pattern emerged when looking at understanding of investigational medicine instructions; 19% of patients with limited education described instructions as “somewhat” or “very” difficult to understand compared to patients who had a higher education (6% “somewhat/very” difficult).

	Patients identifying as Hispanic or Asian also reported increased challenges with investigational medicines. Only 43% of Hispanic patients indicated investigational medicine administration to be “very easy” compared to 79% of Non-Hispanic patients. Just over half (53%) of Asian patients felt taking their medication was “very easy” compared to 78% of White and 74% of African American/Black patients. Both Hispanic and Asian populations experienced a harder time understanding instructions and were also less satisfied with answers to investigational medication-related questions (see Figure 3) from site staff.

	While the method of investigational medicine administration may be challenging and time-consuming to modify, simply providing easy to understand and culturally appropriate investigational medication education and support-particularly to those targeted populations discussed-can readily improve patient experiences and improve compliance. Furthermore, text messaging and other new technologies can also be leveraged to better engage with patients and remind them to take their investigational medicines.

CISCRP Research Services: Jasmine Benger, Nova Getz, Annick Anderson

Providing easy to understand and culturally appropriate investigational medication education and support can make all the difference in improving the patient experience.





Patient Experiences with Clinical Trial Medicines and Instructions

This article is the third in a series on the results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) 2017 Perceptions & Insights Study. 

	When patients around the world are asked what they perceive to be the greatest benefit of participating in a clinical research study, they rank altruistic reasons such as the ability to help advance science and the treatment of a disease (26%) or to help save or improve the lives of other patients living with the same disease (26%) the highest. The third-greatest benefit they mention is the chance to improve one’s own disease or condition (15%). While clinical trial sponsors are unable to guarantee that a study drug will be effective and improve one’s condition, they can take steps to make patients aware of their contributions in these areas and convey that they are a valued research partner. A critical initial step is providing patients a summary of the general study results to allow them to better understand how their participation contributed to the development of a new medical therapy. Eventually, sponsors will share patients’ individual studies to help inform how the study medication may be impacting their condition.  

	Knowing whether or not one will receive a study summary at the end of the individual’s participation is an important factor in the decision to participate in a clinical trial. An overwhelming majority (91%) of patients feel this is “very” or “somewhat” important. African American patients are the most likely to rank knowing whether they would receive a summary of their study results before making a decision to participate as “very important” (66%) when compared to White (56%) or Asian (50%) populations. This suggests that mistrust still exists within this particular population. Sharing trial results could be a new way to build trust and to help this community feel more informed about the benefits and risks of their participation and to ultimately increase engagement.

	When asked what information patients would be the most interested in receiving during their participation in a clinical trial, individual study results (73%) and a summary of the study results (72%) are listed as the top two pieces of information by the general population. North Americans are more likely to find it “very important” to receive this information than other regions, perhaps due to an increased desire to be more proactive with their own health. Additionally, patients over 55 years of age are also more likely to want to receive their individual study results (77%) than younger patients (67%), possibly because older people are more likely to be living with a condition.

	There is also evidence suggesting that the severity of one’s condition shapes expectations in terms of what these patients hope to get out of clinical trial participation. People who report living with very severe conditions are significantly more likely than healthy volunteers to participate in a study because it would help advance treatments for the disease they were managing (73% vs. 33%), or help them obtain better treatment for their condition (70% vs. 8%). Furthermore, patients who rate their condition to be very severe are more likely to mention that it is “very important” to receive a summary of their individual study results (73%) when compared to healthy volunteers (60%). The significance this population places on receiving study results may stem from their heightened desire to identify an effective treatment for their condition and their ability to empathize with others living with the same condition, which would, in turn, peak their interest to see how much of an impact their participation in a clinical research study was making on the treatment of the disease as a whole.

	Even though there is substantial evidence that both pharmaceutical companies and patients would benefit from the sharing of clinical trial results, only 30% of those who participate in a study report ever having received a summary of the study results at the end of their participation. Interestingly, patients who participate in Phase I studies report receiving study results more often than do patients who participate in later study phases. This could be due to a lack of therapeutic benefit for Phase I participants since they are usually healthy and participating for purely altruistic reasons, or because of the lower volume of patients involved in these trials, making it easier for sponsors to gather and disseminate this information.

	The disparity between patients’ desire to receive study results and the low frequency at which they actually receive them highlights opportunities to make patients more informed about the benefits and risks of participation at various stages of their clinical trial experience. It additionally communicates to the patient that the study staff appreciate their participation, and are making an effort to respect them as a valued research partner. Patients who report having received updates on the results of the study at the end of their participation are significantly more likely to report that they “trusted pharmaceutical companies a lot” (30%) to give full and accurate information about the health risks and benefits of new medicines than do those who report not receiving results once their trial participation was over (23%). By providing patients with their clinical trial results, pharma companies can address the motivations that make clinical research participation meaningful to patients, as well as help build the public’s trust in the clinical research enterprise.

The objectives of this study are to establish routine global assessments of public and patient perceptions, motivations, and experiences with clinical research participation to monitor trends and identify opportunities to better inform and engage the public and patients as stakeholders and partners in the clinical research enterprise. 

Between May and July 2017, CISCRP conducted an online international survey. The survey instrument was based in part on questions posed in past surveys. CISCRP received input and support from pharmaceutical, biotechnology, and contract research organizations (CROs), and from investigative sites. A total of 12,427 respondents completed the survey. The online questionnaire was reviewed by an ethical review committee. CISCRP collaborated with Acurian, Clariness, CureClick, HealthUnlocked, and Quintiles to reach and engage respondents.

For more information about CISCRP’s 2017 Perceptions & Insights Study and to download reports, visit

The third in a series of results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) landmark 2017 Perceptions & Insights Study.

Patient Perspectives on Seeing Trial Results

This article is the second in a series on the results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) 2017 Perceptions & Insights Study. Nearly 12,500 people worldwide responded-including the public, patients, and study volunteers-and provided valuable insights into opportunities to improve global education, outreach, and engagement.

	While almost three quarters (71%) of people worldwide who have never participated in a clinical trial indicate they would be willing to do so, 90% indicate that they have never been asked by their doctor. Among individuals managing a disease, less than 25% have had their doctor or nurse suggest a trial as a treatment option.

	In this article, we explore patient perceptions on the importance of the healthcare professional’s (HCP) role in providing support and reliable information in the search for a clinical trial, and highlight new opportunities for increased patient enrollment.

	Currently, those without clinical trial experience indicate that they would most likely begin a search for a clinical trial by asking their own HCP (61%). It should be noted that respondents from Europe were somewhat less likely to do so (54%) when compared to other regions. An online clinical trial registry was also mentioned as a starting point, particularly among those who had previously participated in a clinical trial (50%) who were more likely to use the resource than those who had no prior clinical research experience (38%). A general online search was also frequently mentioned among those who had never participated (31%), with 18-to-34 year olds the most likely (46%) to begin looking for a clinical trial on a search engine such as Google or Yahoo.

	The public reports referring to a variety of sources that could be unreliable or that may lack helpful information that would be useful to know when making a decision to participate. This could contribute to the lack of confidence the public reports feeling in their ability to identify  clinical trials appropriate for them.

	When asked how patients should best learn about clinical research, 64% of non-participants chose their HCP, and additionally felt it was important for their HCP to be aware of clinical trials in their communities (94%). Furthermore, the majority (88%) would find it valuable to learn about study options during a regular doctor visit, with older populations finding this the most valuable (see chart). Yet, 73% of respondents claimed that they never or seldom discussed a clinical trial as a treatment option with their HCP, with respondents from North America, Europe, and Asia-Pacific the most likely to have never discussed study options with their doctor. In contrast, South Americans considered clinical trials as a treatment option during doctor visits the most (59%), and were the most likely to report feeling “Very confident” about finding a clinical trial that is right for them (25%), illustrating the significance of a trusted physician’s involvement in identifying a clinical trial to participate in.

	Patients’ desire to turn to and consult their HCP about participating in clinical trials highlights opportunities for increased enrollment. According to a recent study by the Tufts Center for the Study of Drug Development, the majority of physicians in an online survey (91%) feel comfortable discussing clinical trials as a treatment option with patients, but lack access to trial information (54%), are unsure of where to refer patients (48%), or do not have enough time to learn about the trial (33%). To increase public confidence in finding an appropriate clinical trial and likelihood of HCPs recommending clinical trials as treatment options, pharmaceutical companies should more actively approach doctors well in advance of the enrollment phase. By providing HCPs with ample information about the clinical trial and sufficient time to review, pharma companies can leverage the trusting relationship between doctors and their patients and effectively connect more people to clinical trials right for them.

CISCRP Research Services: Nova Getz, Annick Anderson, Jasmine Benger. 

For more information about CISCRP’s 2017 Perceptions & Insights Study and to download reports, visit 

The second series of results from the Center for Information and Study on Clinical Research Participation’s (CISCRP) landmark 2017 Perceptions & Insights Study.

Patient Input into Leveraging the Healthcare Professional’s Role

This article is the first in a series on the results of the Center for Information and Study on Clinical Research Participation’s (CISCRP) 2017 Perceptions & Insights Study. Nearly 12,500 people worldwide responded-including the public, patients, and study volunteers-and provided valuable insights into opportunities to improve global education, outreach, and engagement

	The overwhelming majority of the public recognizes the important conceptual role that clinical research plays in the discovery and development of new medicines (see chart). This result holds even for those who have never participated in a clinical trial. North Americans and Europeans self-report being the most informed, with more than eight-out-of-ten indicating that they feel “Very” or “Somewhat Informed.” People in the Asia-Pacific region report feeling the least informed (67%). Differences were also observed by age: The youngest age groups, made up of 18-34-year-olds, were more apt to report feeling less informed.

The vast majority (82%) of respondents overall believe that they understand the meaning of the term “clinical research study.” A much higher percentage of women believe that they understand the term than do men. Approximately one-in-ten North Americans report that they do not understand the term well. This compares with 24% of respondents from Africa and 33% of respondents from Asia-Pacific reporting that they do not understand the term well. Age-related differences were also observed as a significantly higher percentage (20%) of 18–34-year-olds report that they don’t understand the term at all.

	But the results of the 2017 Perceptions & Insights study also reveal that the global public has a very superficial understanding about clinical research, suggesting education and outreach as areas of focus. Although a high proportion of the public say that they understand the term “Clinical Research Study,” of those who self-report being “well-informed,” two-thirds are unable to name an agency or organization that oversees clinical research safety and quality, and half (51%) say that they do not know where clinical research is conducted. Differences are observed by geographic region and age. In North America, Europe, and Asia-Pacific, 51%, 52%, and 54% of the public, respectively, say that they don’t know where clinical research is conducted. Older respondents are more apt to know where research was conducted compared to younger age groups.

	Public confusion about the length of time that it takes to develop a new therapy and the proportion of drugs requiring clinical testing was also apparent. Four-out-of-ten people surveyed, for example, believe that it would take five years or less to develop a new drug or therapy.

	Public trust and the perceived safety of clinical research is another critical aspect of overall clinical research literacy. A very high percentage believes that clinical trials are “Somewhat Safe” and “Very Safe,” at 69% and 21% of total respondents, respectively. In this study, only 8% of North and South Americans believe that clinical studies are “Not Very Safe” and “Not at All Safe.” This compares with 12% of the European public and 16% of the Asia-Pacific public sharing this view. Perceptions of clinical research study safety are also a function of age with a significantly higher percentage (14%) of 18–34-year-olds perceiving that studies are unsafe (“Not Very Safe” and “Not at All Safe”).

	These findings highlight opportunities-target audiences and educational content-for stakeholders to strengthen clinical research literacy, familiarity, and relevance and draw the public into a closer relationship with the clinical research enterprise. 

The objectives of this study are to establish routine global assessments of public and patient perceptions, motivations, and experiences with clinical research participation in order to monitor trends and identify opportunities to better inform and engage the public and patients as stakeholders and partners in the clinical research enterprise. 

Between May and July 2017, CISCRP conducted an online international survey. The survey instrument was based in part on questions posed in past surveys. CISCRP received input and support from pharmaceutical, biotechnology, and contract research organizations (CROs), and from investigative sites. A total of 12,427 respondents completed the survey. The online questionnaire was reviewed by an ethical review committee. CISCRP collaborated with Acurian, Clariness, CureClick, HealthUnlocked, and Quintiles to reach and engage respondents. 

For more information about CISCRP’s 2017 Perceptions & Insights study and to download reports, visit 