WIEDZA I NASTAWIENIE DO BADAŃ KLINICZNYCH STUDENTÓW WYBRANEJ UCZELNI MEDYCZNEJ I NIEMEDYCZNEJ W POLSCE

Artur Kotowski1, Dariusz Świetlik2, Maciej Dziachan1, Michał Matulka1, Katarzyna Juszczyńska1, Michał Wronowski3, Maria Kotowska3, Andrzej M. Fal4, 5

1ŁAZARSKI UNIVERSITY, WARSAW, POLAND

2MEDICAL UNIVERSITY OF GDAŃSK, GDANSK, POLAND

3DEPARTMENT OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION, WARSAW MEDICAL UNIVERSITY, WARSAW, POLAND

4DEPARTMENT OF PUBLIC HEALTH, WROCLAW MEDICAL UNIVERSITY, WROCLAW, POLAND

5Cardinal Stefan Wyszyński University, Warsaw, Poland

 

Abstract

Introduction: The development of clinical trials and recruitment of patients remain a major issue worldwide. Apart from administrative barriers the additional challenge is the lack of knowledge about ongoing trials among physicians and patients.

The aim: To compare the knowledge and attitude to clinical trials (CTs) of medical and non-medical university students.

Material and methods: We carried out an anonymous survey (n=382) assessing knowledge, opinions, preferences and expectations of medical university (MU, n=194; 50.8%) and non-medical university (nMU; n=188; 49.2%) students in relation to clinical trials.

Results: In comparison to nMU, MU students significantly more closely associated clinical trials with advances in medicine (p=0.0001) and with the chance of introducing new drugs (p=0.0001). Conversely, nMU vs. MU students significantly associated clinical trials with risk/danger for participants (p=0.0001), with experiments (p=0.0001), with financial benefits for investigators (p=0.0001) and with unethical practices of pharmaceutical companies in order to increase the sales (p=0.0001). In the assessment of general attitude to clinical trials, it was observed that MU students have statistically significantly more positive connotations with clinical trials as compare to nMU students (p=0.0001). Only 6.4% of nMU students stated that the current amount of information on clinical trials is sufficient, and 91.2% expect more information on this subject in the future.

Conclusion: The opinion about clinical trials statistically significantly differed between the groups. Consideration should be given to conducting educational campaigns on clinical trials according to expressed need to increase students’ knowledge.

Streszczenie

Wstęp: Rozwój badań klinicznych i rekrutacja pacjentów, na całym świecie, stanowi duży problem. Wyzwaniem, poza barierami administracyjnymi, pozostaje brak wiedzy o toczących się badaniach klinicznych wśród fachowego personelu i chorych.

Cel pracy: Porównanie wiedzy i nastawienia do badań klinicznych (BK) studentów uczelni medycznej i niemedycznej.

Materiał i metody: Przeprowadziliśmy anonimowe badanie ankietowe (n=382) oceniające wiedzę, opinie, preferencje i oczekiwania w stosunku do badań klinicznych studentów uczelni medycznej (UM; n= 194, 50,8%) i uczelni niemedycznej (UnM; n= 188, 49,2%).

Wyniki: Studenci UM w porównaniu do UnM istotnie statystycznie silniej kojarzyli badania kliniczne z postępem w medycynie (p=0,0001) i z szansą wprowadzenia nowych leków (p=0,0001). Odwrotnie, studenci UnM vs. UM istotnie statystycznie silniej kojarzyli badania kliniczne z ryzykiem/niebezpieczeństwem dla uczestników (p=0,0001), z eksperymentami (p=0,0001), z korzyściami finansowymi dla badaczy (p=0,0001) oraz z nieuczciwym działaniem firm farmaceutycznych mającym na celu wzrost sprzedaży leków (p=0,0001).W ocenie ogólnego nastawienia do badań klinicznych zaobserwowano, że studenci UM vs. UnM istotnie statystycznie silniej kojarzą pozytywnie badania kliniczne (p=0,0001). Zaledwie 6,4% studentów UnM stwierdziło, że aktualna ilość informacji na temat badań klinicznych jest wystarczająca, a 91,2% oczekuje większej ilości informacji na ten temat w przyszłości.

Wnioski: Zaobserwowano istotną statystycznie różnicę między grupami w ocenie badań klinicznych. Należy rozważyć przeprowadzenie akcji edukacyjnych na temat badań klinicznych ze względu na wyrażoną przez studentów potrzebę poszerzania wiedzy.

Public Health Forum 2018;IV(XII)4(47):265-272

INTRODUCTION

The progress of pharmacotherapy depends on the introduction of new medicinal products that before marketing require the assessment of pharmacokinetic parameters, efficacy and safety. This is the aim of clinical trials, e.g. controlled medical experiments, conducted in selected groups of healthy volunteers and patients. According to Evidence Based Medicine (EBM) the prospective, blinded clinical trials with random assignment of patients to study arms (randomization) are the gold standard [1]. This is a complex, cost- and time-consuming process. The scale of the challenge is reflected by the fact that about 9 out of 10 new molecules fail to pass all phases of clinical trials and do not receive marketing authorization, and the average time from discovery of the molecule to its registration is about 12 years with the total cost of clinical trials of the new drug reaching 1.5 billion EUR [2]. The lack of knowledge and scale of the unconsciousness of this problem in the public opinion may be proved by the fact that in the global study on clinical trials awareness (CISCRP), nearly 39.2% of respondents from the general population indicated that according to their opinion the whole process of drug development lasts less than 5 years [3].

The development of clinical trials and recruitment of patients remains a major challenge around the world. While in 2009 totally 469 studies were registered in Poland with 34,000 participants, in 2014 the number of trials was 396 and the number of participants decreased to 29,000 [4]. Apart from administrative barriers the additional challenge is the lack of knowledge about ongoing clinical trials among physicians, so as the result they do not propose their patients to participate in clinical trials. In CISCRP global survey cited above, approximately 45% of respondents admitted that the proposal to participate in a clinical trial was considered as an option when discussing the treatment plan with the physician [3]. In survey by Tohid H., it was observed that only 134 (5.7%) out of 2517 participants received a proposal to participate in a clinical trial [5]. On the other hand, in the societies of many countries there is a wrong belief that clinical trials are associated mainly with risk and danger for participants. Many people do not know at all what a clinical trial is, what laws and regulations govern this field of science, and how the interests of study participants are protected; this varies depending on the geographical region. Among others, the evidence for this are the results of a regional study, which showed that according to 22% of respondents the clinical trials are not conducted in the Arab world, 19% thought that clinical trials in the Arab countries were not subject to any regulations and supervision of the authorities, and according to 15% of respondents local clinical trials are conducted without the consent of study participants [6]. In the study of adult population in Italy, it was shown that 69% of respondents know about the existence of clinical trials, 45% were aware of the existence of bioethics committees, and 29% and 46% showed willingness to participate in either prophylactic or randomized clinical trial, respectively. These percentages were significantly lower when respondents were asked to agree the adolescents to participate in clinical study (5% and 23%, respectively) [7]. In other studies in American population, it was indicated that nearly 40-50% of Americans are not aware of ongoing clinical trials [8,9]. People who do not know the subject much more often indicate unfavorable aspects of research than positive ones. They present the view that patients are used by pharmaceutical companies, clinical trials are dangerous and remain outside the control of state authorities and people are subjected to experiments that may threaten their health or lead to death, results of tests that have not shown efficacy are hidden, data manipulated and researchers lavishly rewarded. Such perception is shaped by media reports on clinical trials focusing on risks rather than the benefits of research [10]. Authors of the publication, which analyze different factors influencing the increase of patients’ involvement in CTs (Sacristán JA et al. 2016) indicate the legitimacy of patient group participation in research projects designing as well as transparency and broad dissemination of achieved results [11,12].

The medical community does not carry out mass educational campaigns aimed at raising the level of knowledge in society and improving the image of clinical trials in the population.

THE AIM OF STUDY

The aim of the study was to compare knowledge and attitudes to clinical trials of medical university (MU) and non-medical university (nMU) students. Students of the Faculty of Medicine at the Medical University of Warsaw (MU) and students of non-medical faculties of a university with a multidisciplinary business profile – Lazarski University in Warsaw (nMU) were selected for the study. Both universities located in the capital of the country occupy prestigious positions in the ranking of universities and educate students from all over the country.

MATERIAL AND METHODS

Participants were selected according to the “convenience” approach, among students of both universities present in the given institution. Potential participants (students), after explaining the purpose of the research and the methodology of data collection and processing, including ensuring the anonymization of collected information, received a questionnaire with request to fill it out individually (Paper and Pencil Interview, PAPI). The questionnaires were grouped at the time of conveying to the research team, which made it impossible to identify the respondent. All collected data were aggregated in the MS Excel file and subjected to statistical analysis. The nature of the study did not require the participant’s written informed consent.

The demographic data included respondents’ age, sex and year of study. The name of the university was a grouping variable for subgroups analyses. The analyses were exploratory.

Research tool

A standardized questionnaire was prepared consisting of 12 closed questions. Questions included the following areas: knowledge, opinions, preferences and expectations. The following scales were used: nominal (YES/NO/DON’T KNOW), the interval Likert scale from 0 to 5 points, where the value “0” meant no associations in a given category, and 5 points – very strong association and interval Likert scale from 0 to 10 points, where the value “0” meant no associations in a given category, and 10 points – a very strong association (for the questionnaire see Appendix).

Statistical analysis

Significance of differences between the two groups was assessed with use of Student’s t-test or Mann-Whitney’s U test. Chi-square independence tests were used for qualitative variables (with use of Yates correction and/or Fisher’s exact test, respectively). In order to determine the relationship, force and direction between variables, the correlation analysis was used calculating Pearson and/or Spearman correlation coefficients. In all calculations, p = 0.05 was assumed as the level of significance.

RESULTS

A total of 382 completed questionnaires were collected out of the 440 distributed (the percentage of MU returns/nMU returns/total was 88.2%/85.5%/86.8%, respectively), of which n=194 (50.8%; 128 women and 66 men) from MU and n=188 (49.2%; 120 women and 68 men) from nMU.

There were no statistically significant differences in sex rate in relation to universities (p=0.6598) or differences in the percentage of students in individual years of study in relation to the universities (p=0.0572).

The baseline characteristics of the studied groups by sex and year of study are presented in Table 1.

Knowledge and awareness

In both groups a high percentage of students (MU, 99.5% vs. nMU, 82.4%; p=0.0001) indicated the need for clinical trials in humans. The question of whether CTs are carried out in Poland was answered in the affirmative by 75.8% vs. 42.6% of MU and nMU students, respectively (p=0.0001).

Benefits or threats

While medical students statistically more closely associated clinical trials with advances in medicine (mean values 4.7/5.0 vs. 4.2/5.0 among nMU students; p=0.0001) and the chance of introducing new drugs/methods of treatment (4.8/5.0 vs. 4.4/5.0; p=0.0001), non-medical students statistically significantly more strongly associated clinical trials with risk/danger for participants (3.5/5.0 vs. 2.6/5.0 among MU students; p=0.0001), experiments (3.8/5.0 vs. 3.1/5.0; p=0.0001), financial benefits for doctors/researchers (3.2/5.0 vs. 2.2/5.0; p=0.0001) and unethical practices of pharmaceutical companies aimed mainly at increasing sales (2.7/5.0 vs. 1.6/5; p=0.0001) (Fig. 1).

The attitude to clinical trials in general was rated on a scale from 0 to 10 points, where 0 points meant markedly negative and 10 points definitely positive; the total rate was 7.5 points, while medical students significantly stronger associated clinical trials with benefits as compare to non-medical students (mean values 8.2 vs 6.8, respectively; p=0.0001) (Fig. 2).

Among MU students of both sexes, a statistically significant positive correlation between the year of study and clinical trials rating was demonstrated (correlation coefficient R=0.17, p=0.0150). The higher the study year, the association of clinical trials with benefits increased.

Opinions

Another part of the survey evaluated the opinions of respondents in the field of ethical aspects of clinical trials. It was asked whether to conduct a research in selected/sensitive groups of people is ethical and permissible: children and adolescents, soldiers, prisoners, people with mental disabilities, healthy people with financial gratification.

The percentage of positive answers of MU and nMU students to the question about allowing the children and adolescents to participate in clinical studies was 59.8% vs. 22.3%, respectively; students of Medical University more often showed the affirmative answer (p=0.0001).

There were no statistically significant differences between MU and nMU students’ answers to the questions about allowing the soldiers (p=0.1831), prisoners (p=0.5610) and people with mental disabilities (p=0.0572) to participate in clinical studies.

The percentage of positive answers of MU and nMU students to the question about allowing the healthy people with financial gratification to participate in clinical studies was 89.7% vs. 70.7%, respectively; students of Medical University more often showed the affirmative answer (p=0.0001) (Table 2).

There were no statistically significant differences between MU and nMU students regarding the response to the question about the necessity of obtaining written consent from the patient before enrollment to the study (94.8% vs. 94.1%, respectively; p=0.7843) or the legitimacy of publishing the clinical trials results, regardless of whether beneficial effects of the new drug was shown or not (94.8% vs. 89.4%, respectively; p=0.1219).

Personal preferences

In all four areas, statistically significant higher percentages of affirmative answers were obtained among medical students. Noteworthy is the very low percentage of consent to the potential participation in the clinical trial of respondent’s child: 14.4% (MU) vs. 7.4% (nMU); p=0.0020 (Table 3).

Expectations

Only 6.4% and 29.4% of nMU and MU students (p=0.0001) stated that the current amount of information on clinical trials reaching them is sufficient; 91.2% and 76.1% of nMU and MU students (p=0.0001) expect more information about clinical trials in the future.

DISCUSSION

To our knowledge, the study comparing the knowledge and attitude towards clinical trials of medical and non-medical students, was the first research project of this type in Poland and worldwide.

The results of the study indicate that students of non-medical studies significantly more closely associated clinical trials with risk/danger for participants (p=0.0001), experiments (p=0.0001), financial benefits for researchers (p=0.0001) and the unethical practices of pharmaceutical companies aimed at increasing the sale (p=0.0001). A statistically significant difference was also observed in the assessment of the general, positive attitude to clinical trials, where the non-medical university students expressed less positive opinions (p=0.0001). The number of information on clinical trials reaching non-medical students seemed to be insufficient (p=0.0001).

The negative attitude of society translates into potentially negative approach toward CTs among patients. McDonald et al. analyzing the recruitment process in 114 studies in the UK in the years 1994-2002 observed that only 31% of them had achieved the recruitment goal and 63% had problems with early recruitment [13]. Patients’ knowledge about clinical trials positively correlated with a favorable opinion about CTs and a potential consent to participate in the study [14-16].

The attempt to evaluate the perception of clinical trials and declarations to participate in the study was evaluated in a cohort of young people, i.e. at the age of 18-34 years (Generation Y) in the global CISCRP study (Nelson 2015) [17]. The study showed a statistically significant difference in the willingness to participate in the clinical trial of persons from Generation Y compared to the elderly. According to the authors, the differences result solely from the nature of the Generation Y and do not depend on age and should be investigated more carefully to improve the perception and attitude to CTs.

Recognition of attitudes among young people, especially those without medical education, is the first step to improve the image of clinical trials and greater acceptance of research in the society, which potentially should have a positive impact on future recruitment. The results of our study revealed that according to the vast majority of respondents, the amount of information on clinical trials is insufficient. Willison D.J. et al. came to similar conclusions in their study on the knowledge and awareness of clinical trials in Canadian society. It turned out that as much as 43% of respondents indicate that the amount of information about studies is insufficient or does not exist at all [18]. Polish students expect broader knowledge in this area in the future. It seems that the involvement of the medical community and the use of social media or medical websites dedicated to clinical trials should improve the knowledge. It is important that the information provided is evidence-based, in line with current clinical practice, legal provisions and ethical guidelines. MacKenzie IS et al. described the positive impact of the campaign conducted by the medical community in the mass media on the perception of CTs in the Scottish society. Campaign “Get randomized” was noticed by 56.7% of respondents, 49% of whom expressed the opinion that it is worth participating in clinical trials [19].

Our study showed a difference in the approach to clinical trials between non-medical and medical students. Comparing to MU students, nMU students were less likely to respond affirmatively to questions about the possibility of conducting CTs among minors/children (22.3% vs. 59.8%, respectively) and people with mental disability (31.9% vs. 38.7%, respectively). People with greater medical knowledge more often advocated conducting clinical trials in these groups. This approach seems to be understandable and rational – people who do not have sufficient knowledge to make a conscious, well-informed decision, (possibly also unconscious of their ignorance) are less likely to respond with an affirmative “YES” aiming the safety of study participants This means that skepticism towards clinical trials is a natural result of ignorance and the result of negative mass media PR. Social education would be the right counter-measure.

In our study it turned out that much higher percentage of medical students (83.5%) in comparison to non-medical students (70.2%) is ready to participate in clinical trials. However, the level of declarations of participation in the study drops significantly when it comes to the participation of children (14.4% vs. 7.4%) or healthy volunteers (28.4% vs. 17.6%).

Thus, the society’s approach has a direct impact on the quality of conducting clinical trials. Easier access to patients will encourage the development of CTs in Poland, which will result in an increase in the value of the research market and an increase in the demand for qualified staff.

The limitation of the project was the non-random selection of respondents (the convenience sampling/opportunity sampling method), the choice of two prestigious universities located in the capital of the country, including one (nMU) in which the studies are paid. The aforementioned factors could affect the unrepresentativeness of the groups in the study, hence the recommendation to conduct a similar research project on a wider population.

In our opinion, educational activities should be planned, carried out and focus on three main aspects: ethics in clinical trials, control mechanisms in terms of participants safety and highlighting potential benefits for patients. Patients’ organizations that associate people who do not have direct financial benefits from clinical trials can play an important role.

CONCLUSIONS

In the whole study population a statistically significant difference in the overall assessment of clinical trials by medical and non-medical students was observed. The results obtained should be treated with caution and a similar study representative to the nationwide population should be considered. Due to the fact that majority of students expect more information on clinical trials in the future, consideration should be given to conducting educational activities on this topic.

References

1. Burns PB, Rohrich RJ, Chung KC. The levels of evidence and their role in evidence-based medicine. Plast Reconstr Surg. 2011, 128 (1): 305-310

2. Timeline of a pharmaceutical drug development-from an idea to the market https://scientifist.com/timeline-pharmaceutical-drug-development-idea-market; accessed 2018.12.01

3. Anderson A, Borfitz D, Getz K. Global public attitudes about clinical research and patient experiences with clinical trials. JAMA Network Open. 2018; 1(6): e182969. doi:10.1001/jamanetworkopen.2018.2969

4. https://www.pwc.pl/pl/pdf/badania-kliniczne-raport-pwc.pdf accessed 2018.12.01

5. Tohid H, Choudhury SM, Agouba S, Aden A, Ahmed LHM, Omar O, Chagoury O, Taheri S. Perceptions and attitudes to clinical research participation in Qatar. Contemp Clin Trials Commun. 2017, 1; 8: 241-247

6. Bazarbashi S, Hassan A, Eldin AM, Soudy H, Hussain F. Awareness and perceptions of clinical trials in cancer patients and their families in Saudi Arabia. J Cancer Educ. 2015, 30 (4): 655-659

7. Mosconi P, Poli P, Giolo A, Apolone G. How Italian health consumers feel about clinical research: a questionnaire survey European Journal of Public Health 2005, 15, 4: 372–379

8. Mistea E, Survey: 50% of Americans not aware of clinical trials https://www.clinicalleader.com/doc/survey-of-americans-not-aware-of-clinical-trials-0001 accessed 2018.12.01

9. Comis RL, Miller JD, Aldige CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials J Clin Oncol, 2003, 21, 5: 830-835

10. The Deadly Corruption of Clinical Trials https://www.motherjones.com/environment/2010/09/dan-markingson-drug-trial-astrazeneca/ accessed 2018.12.01

11. Vayena E. The next step in the patient revolution: patients initiating and leading research. BMJ. 2014; 349:g4318.

12. Kaye J, Curren L, Anderson N, Edwards K, Fullerton SM, Kanellopoulou N, Lund D, MacArthur DG, Mascalzoni D, Shepherd J, Taylor PL, Terry SF, Winter SF. From patients to partners: participant-centric initiatives in biomedical research. Nat Rev Genet. 2012; 13: 371–376

13. McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, Snowdon C. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006 Apr 7; 7: 9

14. Lim Y, Lim JM, BA, Jeong WJ et al. Korean Cancer Patients’ Awareness of clinical trials, perceptions on the benefit and willingness to participate Cancer Res Treat. 2017; 49 (4): 1033-1043

15. Brintnall-Karabelas J, Sung S, Cadman ME, Squires C, Whorton K, Pao M. Improving Recruitment in Clinical Trials: Why Eligible Participants DeclineJ Empir Res Hum Res Ethics. 2011; 6(1): 69–74

16. Ohmann C, Deimling A. Attitude towards clinical trials: results of a survey of persons interested in research. Inflamm Res. 2004; 53 Suppl 2: 142-147

17. Nelson AM, Martin IG, Getz KA. Generational value differences affecting public perceptions of and willingness to participate in clinical trials. Ther Innov Regul Sci. 2015; 49 (6): 940-946

18. Willison DJ, Richards DP, Orth A, Harris H, Marlin S. Survey of awareness and perceptions of Canadians on the benefits and risks of clinical trials Ther Innov Regul Sci. 2018 Oct 29. doi: 10.1177/2168479018805433.

19. Mackenzie IS, Wei L, Rutherford D, Findlay EA, Saywood W, Campbell MK, MacDonald TM Promoting public awareness of randomised clinical trials using the media: the ‘Get Randomised’ campaign Br J Clin Pharmacol. 2010;69:2:128–135

Conflict of interest:

Authors declare no conflict of interest

Corresponding author:

Artur Kotowski

Łazarski University,

Warsaw, Poland

e-mail: kotowski.a@gmail.com

Received: 15.11.2018

Accepted: 30.12.2018

MU

(N=194)

nMU

(N=188)

Total

(N=382)

P-value

Sex

0.6598

female

128 (66.0%)

120 (63.8%)

248 (64.9%)

male

66 (34.0%)

68 (36.2%)

134 (35.1%)

Study year

0.0572

1-3

101 (52.1%)

116 (61.7%)

217 (56.8%)

4-5

93 (47.9%)

72 (38.3%)

165 (43.2%)

Table. 1. The baseline characteristics of the studied groups by sex and year of study.

*p=0.0001

Fig. 1. Mean values of answers to the question “Evaluate by means of a scale to what extent do you associate the term clinical trials with the following questions (0 – no associations; 5 – strong association): “A. Progress in medicine, B. Chance of introducing new drugs, C. Experiments, D. Risk/danger, E. Financial benefits for the patient, F. Financial benefits for doctors, G. Unethical practices of pharmaceutical companies aimed at increasing the sale of medicines”.

*p=0.0001

Fig. 2. Comparative characteristics of evaluated groups in terms of the answer to the question “Taking into account all the above aspects, do you associate clinical trials with benefits/opportunities (10 points) or threats/risks (0 points) on the scale 0-10 points?”.

MU

(N=194)

nMU

(N=188)

P-value

Children and adolescents

0.0001

Yes

116 (59.8%)

42 (22.3%)

No

52 (26.8%)

120 (63.8%)

Don’t know/Have no opinion

26 (13.4%)

26 (13.8%)

Soldiers

0.1831

Yes

108 (55.7%)

96 (51.1%)

No

63 (32.5%)

57 (30.3%)

Don’t know/Have no opinion

23 (11.9%)

35 (18.6%)

Prisoners

0.5610

Yes

127 (65.5%)

130 (69.1%)

No

47 (24.2%)

37 (19.7%)

Don’t know/Have no opinion

20 (10.3%)

21 (11.2%)

People with mental disabilities

0.0572

Yes

75 (38.7%)

60 (31.9%)

No

94 (48.5%)

87 (46.3%)

Don’t know/Have no opinion

25 (12.9%)

41 (21.8%)

Healthy people with financial gratification

0.0001

Yes

174 (89.7%)

133 (70.7%)

No

8 (4.1%)

25 (13.3%)

Don’t know/Have no opinion

12 (6.2%)

30 (16.0%)

Table 2. Comparative characteristics of studied groups in terms of the answer to the question “According to your opinion is it ethical and acceptable to conduct clinical trials in mentioned groups of patients?”

MU

(N=194)

nMU

(N=188)

P-value

If you were ill person, would you agree to participate in a clinical trial?

0.0004

Yes

162 (83.5%)

132 (70.2%)

No

8 (4.1%)

30 (16.0%)

Don’t know/Have no opinion

24 (12.4%)

26 (13.8%)

If you had children, would you agree for the participation of your child in the study?

0.0020

Yes

28 (14.4%)

14 (7.4%)

No

114 (58.8%)

142 (75.5%)

Don’t know/Have no opinion

52 (26.8%)

32 (17.0%)

If you had an ill relative, would you encourage him/her to participate in a clinical trial?

0.0001

Yes

137 (70.6%)

96 (51.1%)

No

16 (8.2%)

38 (20.2%)

Don’t know/Have no opinion

41 (21.1%)

54 (28.7%)

If you were a healthy person, would you agree to participate in a clinical trial?

0.0074

Yes

55 (28.4%)

33 (17.6%)

No

92 (47.4%)

118 (62.8%)

Don’t know/Have no opinion

47 (24.2%)

37 (19.7%)

Table 3. Comparative characteristics of studied groups in terms of answers to the question about personal preferences in relation to participation in a clinical trial.

Appendix 1.

Number

QUESTION

ANSWER

1

According to your knowledge, are clinical trials involving people needed?

YES

NO

DON’T KNOW

2.

According to your knowledge are clinical trials testing the new drugs and involving humans carried out in Poland?

YES

NO

DON’T KNOW

3

What do you associate clinical research with?

– advances in medicine

– risk/danger for study participants

– the opportunity to introduce new drugs/treatments

– financial benefits for patients

– experiments

– financial benefits for doctors (researchers)

– unethical practices of pharmaceutical companies aimed at increasing the sale of the drug

0

0

0

0

0

0

0

1

1

1

1

1

1

1

2

2

2

2

2

2

2

3

3

3

3

3

3

3

4

4

4

4

4

4

4

5

5

5

5

5

5

5

3a.

Considering all of the above aspects, do you associate clinical research with benefits (opportunities) or risks – rate on scoring scale 0-10 points.

0

1

2

3

4

5

6

7

8

9

10

4

According to your opinion is it ethical and permissible to conduct research:

in children and adolescent

– soldiers of active service

– prisoners

– in mentally disabled people/with mental illness

– in healthy people with financial gratification

YES

YES

YES

YES

YES

NO

NO

NO

NO

NO

DON’T KNOW

DON’T KNOW

DON’T KNOW

DON’T KNOW

5

According to your opinion, should written informed consent always be obtained from the patient before the start of the study?

YES

NO

DON’T KNOW

6

Should the results of clinical trials be published (available to the public) regardless of the achieved result, i.e. both when they do or do not show the benefit ?

YES

NO

DON’T KNOW

7

If you were a healthy person, would you like to take part in a clinical trial of a new, unregistered medicine with a financial gratuity?

YES

NO

DON’T KNOW

8

If you were ill person, would you take part in a clinical trial with a new, not registered yet drug tested for this disease (without financial gratification)?

YES

NO

DON’T KNOW

9

If you had children, would you agree that your child participates in a clinical trial (e.g. with immunization preparation)?

YES

NO

DON’T KNOW

10

If you had an ill person among your relatives would you encourage him/her to take part in a clinical trial with a new drug which is not registered yet?

YES

NO

DON’T KNOW

11

According to your opinion, is the amount of information about clinical trials currently reaching you sufficient?

YES

NO

DON’T KNOW

12

Would you like to know more about clinical trials in the future?

YES

NO

DON’T KNOW