Trends in Global Public and Patient Perceptions of Clinical Research

Introduction

Table 1. Respondent Demographics

2013

2017

(n=5,700)

(n=12,427)

Gender

% mentioning

Male

42%

40%

Female

58%

59%

Region

North America

75%

46%

South America

5%

7%

Europe

15%

28%

Asia-Pacific

5%

14%

Africa

◊

5%

Clinical Trial Participation

Yes

39%

18% 

No

61%

82%

Age Range

18-34

18%

13%

35-44

17%

11%

45-54

23%

19%

55-64

26%

27%

65+

16%

29%

Race

Black/African American

◊

6%

White

◊

81%

Asian

◊

5%

Ɨ (p ≤ 0.05)

◊ Not asked in 2013 study 

Public confidence and trust in the clinical research enterprise, and positive sentiments and experiences with clinical research activity, are all essential success factors in the development of medical interventions. These factors play a critical role in establishing a number of critical relationship conditions including:

· Consumer support for products and practices that have been evaluated and approved following clinical research testing and regulatory review cycles;

· Public support and appreciation for the professionals involved in the development and approval of new medical interventions;

· Policymaker and political support for reforms and incentives that enable the clinical research enterprise to perform effectively, safely and efficiently; and

· Patient willingness to make the courageous decision to participate in clinical trials.

To inform our understanding of public and patient trust and confidence, this article provides a high-level summary of the results of two studies monitoring trends in international public and patient attitudes and perceptions. The non-profit Center for Information and Study on Clinical Research Participation (CISCRP)-in collaboration with Acurian and other organizations-conducted international surveys in 2013 and 2017. Insights from these surveys help illuminate new areas of opportunity to address gaps in public and patient awareness and education, and improve patient recruitment and retention effectiveness while ensuring the highest levels of patient engagement throughout the clinical trial experience. For a more detailed discussion of the study results, please visit www.ciscrp.org. 

During the past five years, most public and patient perceptions and attitudes about clinical research have remained generally the same, though there are some notable exceptions including clinical research literacy levels and participation preference shifts. Since 2013, the self-reported ability to find a clinical trial has increased, and perceptions of clinical trial safety have shifted. The 2017 global survey also introduced questions exploring the role of the health care provider in supporting clinical trial participation. 

Methods

CISCRP received input on the survey instrument design from patients and clinical research professionals. Both the 2013 and 2017 surveys were disseminated online in the spring, primarily through Acurian’s global, direct-to-patient network. The 2017 survey received 12,427 responses, making it the largest global survey of its kind ever conducted and more than doubling the responses received in 2013. Table 1 summarizes respondent demographics (see table 1). 

In 2013, the survey was limited to North America, South America, Europe, and Asia-Pacific, whereas in 2017, the survey reached respondents in Africa in addition to the other regions. The 2013 study had significantly more respondents with clinical trial experience compared to those from the 2017 study. In 2017, there were significantly more respondents from Europe and the Asia-Pacific and there were significantly more respondents over 65 years of age. 

Results

Awareness and Perceptions of Clinical Trials

The public’s knowledge and awareness of clinical trials have stayed relatively the same. Despite the majority claiming they understand what is meant by the term “clinical trial,” findings from both surveys suggest this knowledge is superficial at best. Over the years, similar proportions of the public indicate that they understand what a clinical trial is (90% indicating “yes,” they understood in 2013, and 82% indicating they understood “somewhat” or “very well” in 2017), yet many are not sure about how much of a role clinical research plays in the development of new medications. One-third (34%) of respondents from the 2017 survey believe that not all drugs approved for the market must go through the clinical trial process. This question was not asked in the earlier time period. 

Perceptions about clinical trial safety have shifted slightly between 2013 and 2017. In the more recent period, the proportion of respondents indicating that they perceived clinical trials to be “very safe” is lower than that reported in 2013. The proportion agreeing that clinical trials are “somewhat safe” absorbed most of the shift. (see figure 1). 

A similar trend can be seen in the public’s reported “high willingness” to participate in a clinical trial, which decreased between 2013 (50%) to 2017 (31%), but shifted over to the softer willingness group.  

Table 2. Confidence in Finding a Trial “Right for You”

2013

2017

(n=5,700)

(n=12,247)

Not at all confident

11%

8%  Æ—

Not very confident

33%

31%

Somewhat confident

44%

43%

Very confident

11%

18%  Æ—

Ɨ (p ≤ 0.05)

The proportion of people feeling “very confident” in finding an appropriate clinical trial has risen significantly since 2013 from one in 10 (11%) to one in five (18% in 2017). 

Barriers to Participation

Table 3. Where Patients Prefer to Learn about Clinical Trials

Most preferred place to learn about clinical trials

2013

(n=5,700)

My primary care physician (PCP)

52%

My specialty care doctor

41%

The internet (e.g., social media channels/websites/online disease forums)

32%

Messages and notifications sent to me by email

30%

The media (e.g., announcements on TV/radio/newspaper/magazine/etc.)

22%

How should people best learn about clinical research?

2017

(n=12,427)

During discussions with my primary care physician (general practitioner) or specialist about treatment options

64%

Educational information at my primary care physician (general practitioner) or specialist's office

56%

An educational program in a hospital

36%

Educational information found on the internet

35%

Educational information from a patient advocacy/patient support group

29%

Several barriers to clinical research participation exist at various stages of the clinical trial journey-including limited awareness of clinical trials actively recruiting  and limited understanding about the requirements and demands of participation. When asked where patients should best learn about clinical research opportunities, respondents in 2017 shared similar perspectives with those from 2013. The desire to learn about clinical trials from a regular doctor was paramount to respondents in both years (see Table 3). While not asked in 2013, a question regarding where patients would most likely begin a search for a clinical trial offered additional insight in 2017 about just how important it is for patients to be able to communicate directly with their doctor, as the majority of patients (58%) would begin their search by asking their primary care doctor. The internet-although a lower preference source for clinical trial information-was named a preferred source by approximately one-third of respondents in both time periods.  

Despite the high level of importance that patients place on learning about clinical research opportunities from their regular doctor, close to 70% of respondents in 2017 reported that they never or rarely considered clinical studies as an option when discussing treatment or medication options with their doctor. In Europe and Asia-Pacific regions, significantly fewer patients consider clinical trials as a treatment option when compared to other regions. 

The possibility of side effects, harm to overall health, and the possibility of receiving a placebo are the top three perceived risks associated with participating in a clinical trial (see figure 2). These remain the top three perceived risks during both time periods, though the proportions of respondents concerned about side-effect risk and the possibility of receiving a placebo were much higher in 2013. Respondents in the Asia-Pacific region in 2017 were significantly more likely than other geographic areas to be concerned about the possibility of side effects, while elderly populations expressed concern about receiving a placebo or having continued access to a study drug once their clinical trial participation was over. Younger respondents in 2017 were significantly more worried than older populations about potentially missing work. 

Respondents in 2013 and 2017 who reviewed the informed consent form but ultimately chose not to participate did so for different reasons at each time period. In 2013, the top three reported reasons were largely associated with convenience factors: the research center was difficult to travel to (18%), they could not take time away from their job (17%), and participation in the clinical trial was too time intensive (17%). In 2017, respondents ranked fear of side effects (30%), too many visits to the study center (20%), and invasive medical procedures (19%) as the top reasons why they chose not to participate in a trial after reading the informed consent form. 

After discovering that they did not qualify for a clinical trial, similar proportions of respondents in both 2013 and 2017 decided not to pursue participating in another clinical study (see figure 3). 

Participation Experiences 

Table 4. Least Enjoyed Aspects of Clinical Trial Participation

What did you like LEAST?

2017

(n=2,194)

Possibility of getting placebo

24%

Location of study center too far 

23%

Study visits too time consuming

11%

Side effects

11%

Compensation not enough

9%

Approximately one-third of respondents-in 2013 and 2017 found the informed consent form “difficult to understand.”  Respondents report it is most often the study coordinator who reviews the informed consent form with them. The Principal Investigator and administrative staff are mentioned as the primary reviewers of the informed consent form by one out of five study volunteers (see figure 4). 

Patients in the 2017 survey were additionally asked to reflect upon their experiences participating in the clinical trial, and to report their least favorite aspects of clinical trial participation. Three of the top five least enjoyed aspects of participation are associated with participation burden and inconvenience: Location of the investigative site, time intensive nature of the study visits, and payments failing to adequately compensate for participation requirements.

The 2017 survey also found that the majority (66%) of study volunteers find it important to keep their doctor informed of their progress throughout the duration of their participation in a clinical trial, and a little over half (53%) of the respondents in 2017 would have found it “very convenient” to have clinical research procedures performed during their regular doctor visits instead of having to make a separate visit to the study site. 

Concluding Thoughts 

Sustained high global levels of public willingness to participate in clinical research, and the growing level of confidence in finding appropriate clinical trials, are positive takeaways. Low levels of public clinical research literacy, global respondents’ perceived importance and preference for better integrating health care provider involvement, and feedback on the burden and inconvenience of study participation offer insights into areas of opportunity to increase public and patient engagement before, during, and after enrollment.

Nova Getz, Center for Information and Study on Clinical Research Participation (CISCRP)*; Scott Connor, Acurian; Annick Anderson, CISCRP; Ken Getz, CISCRP                                    

* Corresponding Author