New Survey Shows Public Perception of Opportunity to Participate in Clinical Trials Has Decreased Slightly From Last Year

3 2004 data is from Harris Interactive Healthcare News, Volume 4, Issue 10, June 11, 2004.

Those who have participated in clinical trials indicate a range of reasons for their participation. While these vary slightly in magnitude from year to year, the top response has continued to remain the same since 2001 – about half (51%) indicate that they participate in clinical studies to advance medicine and science.

The overall order of the reasons has retained a similar pattern; however, in 2005 there are some notable changes. There is an increase in those who indicated their doctor recommended the study as a reason they decided to participate in a clinical research study (31% now compared to 21% in 2004). Additionally there are several key decreases in both the financial benefits and education and media coverage areas:

• More than one-third (36%) of adults who participated in clinical trials said they did so to earn extra money, down from 50 percent in 2004.
• One in five (19%) participated to obtain free medication, down from 27 percent in 2004.
• Thirty percent (30%) participated to obtain education about treatment/improving their health, a decrease of nine percentage points from 2004 (39%).
• One-quarter (25%) indicated they participated in clinical studies because the information they read, saw or had heard about the study influenced them, down from 41 percent in 2004.

"Please indicate which of the following, if any, are reasons you decided to participate in a clinical research study. Please select all that apply."

Base: Have ever participated in a clinical research study

Note: Multiple-response question.

* Family/Friend recommended the study was a combined question in 2004.

NA = Not Asked

It appears that the draw of financial benefits attached to clinical studies may be waning for participants, and the recommendations by doctors may be a growing influence to participation. While last year the media coverage was critical to participants, this year it may be more of a liability. This may stem from recent public controversy over the potentially dangerous side effects of certain prescription drugs and, on a larger scale, more coverage of clinical studies in general and of the FDA (U.S. Food and Drug Administration). Over half of all respondents (55%) and nearly two-thirds (64%) of those who have previously participated in a clinical study believe that pharmaceutical companies’ reputations have been most affected (compared to the FDA, pharmacies, doctors, and clinical studies in general) by the recent events surrounding various prescription drugs such as Vioxx, Celebrex and Naproxen.

"There have been recent reports of potentially dangerous side effects related to some frequently used prescription drugs, such as Vioxx, Celebrex and Naproxen. In your opinion, whose reputation has been most affected by these events?"

Base: All Adults

Those who said they would consider participating in a clinical research study in the future also cite a variety of reasons. Again, the majority of the top reasons cited this year remain the same as in 2004.

Factors that are "very likely" to influence majorities of those who are considering participation in clinical research studies include:

• If I had a terminal illness (72%)
• If I thought the drug might cure me (67%)
• If there were no other medical options available to me (66%)
• If I knew there were no risks involved (61%)
• If I thought the drug/treatment would help me (61%)
• The treatment were free of charge to me (53%).

Smaller, but still substantial groups, indicated they were very likely to participate in the following scenarios:

• If my doctor recommended it (47%)
• If I received money for participating (46%)
• If I knew the risks associated with the treatment (45%)
• If I thought the drug/treatment would help someone else in the future (45%)
• If it were convenient for me to participate (43%)
• If the location were convenient for me (43%)
• If there were minimal side effects associated with the treatment (43%).

The financial connection to clinical research studies is declining as a motivation of potential new subjects, as well. While money is a factor for about half of those who would consider participating, it has fallen significantly both in terms of free treatment (53% now compared to 64% in 2004) and money for participating (46% now compared to 56% in 2004).

The primary reasons for considering participation in clinical research studies are still centered on the person themselves and their conditions and medical options.

"On a scale from 1-5, with 1 being "Not likely" and 5 being "Very likely", please rate the factors below on their likeliness to influence your decision to participate in a clinical research study."

Percent saying "5" ("very likely")

Base: Would consider participating in a clinical research study

NA = Not Asked

The overwhelming majority of adults who have participated in clinical trials have very positive views of the informed consent process. Large majorities strongly agree that they understood participation was voluntary (84%) and that they were agreeing to participate in a clinical research study (83%). Three-quarters or more of participants understood what was required of them (78%); knew they could stop participating at any time (75%); and felt comfortable asking additional questions regarding the study (75%). Substantial majorities also felt secure that their confidentiality was protected (69%) and that they were made aware of both the benefits (68%) and risks (65%) to participation.

Similar to last year, most participants found the purpose of the study to be clear after reading the informed consent (85%) and agreed that their questions were generally answered by the study team regarding the informed consent process (80%).

"The following statements describe how well the process was explained to you when you agreed to be part of the clinical research study. Using the scale below, please indicate how strongly you agree or disagree with the statements below."

Percent saying "strongly agree"

Base: Have ever participated in a clinical research study

Base: Have ever participated in a clinical research study

Participation in clinical studies appears to be a positive experience for those involved. Most of those who participated in a study would do so again, if given that chance (84%). Furthermore, a strong majority of participants (81%) describe their appointments at the study site as "not at all stressful."

Physicians play an important role in a person’s decision to participate in a clinical research study. More than one-quarter (27%) of those who participated in a study said that their physician was their main influence in deciding to participate. Additionally, 79 percent of adults who are willing to participate in a clinical research study with an unfamiliar physician or those who are not sure indicate that they would be very or somewhat likely to check with their regular physician before participating in a clinical research study he/she is not conducting. Finally, nearly half (45%) of those who have ever participated in a clinical research study indicate that they learned everything they needed to know from the doctor/study team before deciding whether or not to participate.

Base: Have ever participated in a clinical study

Most adults agree that people who participate in clinical research studies are making a contribution to science (86%), are part of an experiment to test medications/treatments not already available to the public (79%), and that they learn more about their condition and health in general (76%). Smaller majorities agree that people who participate in studies have a chance to get free medicine (65%) and do not have to pay for their medical care (53%). About half of respondents agree that participants in clinical studies are taking a gamble with their health (49%) and are treated like guinea pigs (46%).

"The following statements describe how some people feel about clinical research studies. Using the scale below, please indicate how strongly you agree or disagree with the statements below. People who participate in clinical research studies…."

Percent saying "strongly agree" or "somewhat agree"

Base: All Adults

The public sees the greatest risks to participating in clinical studies to be possible side effects (47%) and health risks (32%) and sees the greatest benefits as helping to advance science and find a cure for diseases/conditions (36%) and helping to save lives (24%).

"Which of the following do you consider to be the greatest risk of participating in a clinical research study?"

Base: All Adults

Note: Single-response question.

"Which of the following do you consider to be the greatest benefit of clinical research studies?"

Base: All Adults

Note: Single-response question.

While nearly two in five (38%) adults say the media is their main source of receiving information about clinical research studies and most (83%) understand what clinical research studies are, half (51%) of all adults indicate they would prefer to learn about clinical research studies from their regular physician.

Base: All Adults

NA = Not Asked

Initial reaction to online clinical trial registries is somewhat skeptical with 20 percent of adults indicating they would be not at all likely to use the service.

That said, majorities of respondents feel that all types of clinical trials should be listed in the registries (73%) and that all results, regardless of success, should be available in these registries (79%). There is mixed reaction on how to present the results with 41 percent believing the results should be in easy-to-understand layman’s terms and 34 percent believing they should be in both layman’s terms and scientific terms. There is also no consensus on the purpose of these registries although most ideas center on information sharing, with 40 percent saying their purpose is to promote research, 36 percent saying it is to increase awareness of clinical trials and 32 percent saying it is to share experiences of clinical trials.

Base: All Adults

Most people (72%) believe that physician interest in finding new and better treatments is "very important" to physicians conducting clinical research. Furthermore, 59 percent rated "patients who have no other treatment alternatives" as "very important" to physicians conducting clinical research.

Fewer people believe that fame and recognition (16%), getting a scientific paper published (20%) or receiving money from drug companies (27%) are very important to physicians conducting clinical research. These patterns are consistent with 2004 results.

"Please rate how important you think each of the following is to physicians conducting clinical research."

(Percent saying "very important")

Base: All Adults

NA = Not Asked

A majority of respondents (62%) rate "receiving money from drug sales" as "very important" to pharmaceutical companies conducting clinical research while more than half (57%) believe that finding new and better treatments is "very important" to pharmaceutical companies conducting research studies.

"Please rate how important you think each of the following is to pharmaceutical companies conducting clinical research."

(Percent saying "very important")

Base: All Adults

Overall public opinion in relation to clinical research studies appears similar to last year. However, there are a few very notable differences. There is a slight reduction in the number of adults who have had the opportunity to participate in clinical research studies. The allure of financial benefits appears to be less of a draw to both those who have participated in the past and those who are considering it in the future. For those who have participated in clinical research studies, the involvement of their physician appears to be important. Public perceptions of clinical research studies remain similar to past years and the public is still gathering most of their information from the media. The public appears skeptical to the initial introduction of online clinical trial registries for themselves, but they are open to the information sharing they could provide.

Downloadable PDFs of the Harris Interactive Healthcare News are available at http://www.harrisinteractive.com/news/newsletters_healthcare.asp

Methodology
This survey was conducted online within the United States between April 19 and 26, 2005 among a nationwide cross section of 2,261 adults (aged 18 and over). Data were weighted for age, education, income, gender, race/ethnicity and region where necessary to bring them into line with their actual proportions in the population. Propensity score weighting was also used to adjust for respondents’ propensity to be online.

In theory, with probability samples of this size, one could say with 95 percent certainty that the results from the total sample have a sampling error of plus or minus 3 percentage points of what they would be if the entire U.S. adult population had been polled with complete accuracy. Sampling error for the sub-samples of those who have participated in a clinical research study (261), those who would consider participating in a clinical research study (1,525), and those willing to participate in a clinical research study with an unfamiliar physician or those who are not sure (2,118) is higher and varies. Unfortunately, there are several other possible sources of error in all polls or surveys that are probably more serious than theoretical calculations of sampling error. They include refusals to be interviewed (nonresponse), question wording and question order, and weighting. It is impossible to quantify the errors that may result from these factors. These online samples were not probability samples.

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