Public awareness and perception of clinical trials in Montenegro A

Public awareness and perception of clinical trials in Montenegro A Snežana S. Mugoša1, Berina I. Kučević1, Marta S. Rolevski1, Zoran M. Bukumirić2, Željka M. Bešović1, Milorad D. Drljević1 A 1 Agency for Medicines and Medical Devices of Montenegro, Podgorica, Montenegro 2 Institute for Medical Statistics and Informatics, Medical faculty of Belgrade, University of Belgrade, Belgrade, Serbia A SUMMARY


INTRODUCTION
According to the Directive 2001/20/EC of the European Parliament and of the Council, clinical trial is any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic eff ects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investiga-tional medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or effi cacy [1].Clinical trials (CTs) are research studies that explore whether a medical strategy, treatment or device is safe and eff ective for humans [2].Clinical trials are important from several aspects: to a patient, clinical trial represents a unique opportunity to obtain free innovative medicine, i.e. most modern treatment; participants in clinical trials have the opportunity to help with the treatment of certain diseases not to themselves only, but also to future generations.Importance of clinical trials to a researcher is faster access to a new medicine and new treatment options.Clinical trials aff ect the reputation of researchers, hospitals, universities and society as a whole.Financial aspect is also important, not only in terms of material benefi ts to researchers and center in which the trial is conducted, but primarily in terms of saving funds necessary for purchasing new medicines that are still being examined or have not yet been placed onto the market [2].
Th e importance of awareness of the general public about CTs is so that they can decide whether they want to participate in them or not [3].Positive example of this awareness is that information obtained through clinical trials has helped raise the cure rate for pediatric cancers to more than 70% overall, with some childhood malignancies achieving more than 90% cure rates [4].
Th is aim of this study was to investigate the awareness of clinical trials, perceptions of favorable feelings about CTs, necessity and safety of them, the ultimate benefi t of CTs, as well as the factors associated with willingness to participate in CTs among the general population in Montenegro.

METHODS
Th e survey tool consisted of open-ended questions designed by authors that assessed the awareness and attitudes of the individuals regarding the CTs.Th e data from questionnaire completed by 400 randomly selected people (general population) aged 18 and over was collected.Absolute and relative numbers were used in the description of data.Hi-square test was used to test the hypothesis about the difference of frequency.Th e statistical hypotheses were tested at the level of statistical signifi cance (alpha level) of 0.05.Statistical data analysis was performed using IBM SPSS Statistics 22.
Th e qualitative fi ndings were also borne out in the general public survey with 58,5% (234) of the population claiming to understand the term "clinical trial", while 75 subjects (18,8%) did not know what CTs are and 91 of them (22,7%) were not entirely certain what the term means.Th ere were statistically signifi cant gender diff erences with regards to clinical trials awareness: only 44,2% of all male subjects versus 70,8% of all female ones were informed about the defi nition of clinical trials (p<0,001).Among the subjects who responded that they knew what CTs were, 146 of them (36,5%) obtained the information regarding CTs from media and internet, 57 of them (14,5%) from doctors and pharmacists, while 31 of them (7,8%) got them during their education.When asked -Who has the greatest responsibility for public education about clinical trials -32,8% of subjects considered it to be Ministry of Health, 28% considered it to be doctors and pharmacists, while 15% considered it to be Agency for Medicines and Medical Devices of Montenegro.
While 49,8% women thought that medicines on the market were clinically tested, 47,5% men were not sure about that (p=0,037).81,7% of subjects considered that clinical trials had great signifi cance for the development of medicine and treatment of diseases, while 16,3% considered them to be of medium signifi cance.4 subjects (1%) thought that CTs had little signifi cance and the remaining 4 subjects (1%) considered them entirely unimportant for the development of medicine and treatment of diseases.
33,3% of all participants believed that patients sometimes are involved in CTs without their knowledge, 31,2% thought that it is not so, while 35,5% were not sure.
Th e main motive to participate in a clinical trial for 37,5% of participants (150) was curing of any illness, for 20,3% (81) it was the possible existence of fi nancial compensation, for 21% (84) it was personal contribution to the development of science and medicine, while for 9,8% (39) it would be the advice by their chosen general practitioner.Th e remaining 11,5% (46) would by no means want to participate in clinical trials.
Th e main motive for clinical trial enrolment for subjects under the age of 25 and over the age of 50 was curing the existing disease, while for subjects aged 26-50 was fi nan-cial reimbursement (37,6% and 44,2% versus 34,9%; p<0,001).
Th e main motive for not being involved in the clinical trial for 286 patients (71,5%) was the fear of side eff ects of a new drug, for 53 (13,3%) it was a lack of trust in doctors, for 33 (8,2%) it was the fear that the drug would not be more eff ective than current therapy, while for the remaining 28 (7%) it was the time dedicated for frequent check-ups.
Of all participants, 290 said they would never have participated as subjects in clinical trials (72,5%), while 110 (27,5%) would participate in clinical trials.45,8% participants consider taking part in clinical trials dangerous, 14% consider not dangerous, while 40,2% were not sure.

DISCUSSION
Th e results of our study showed that the public awareness of CTs is low.An interesting observation was that in spite of the high education level of our subjects, majority didn't entirely understand the basic concept of CTs.Nearly half of participants believed that medicines which are available to us were not clinically tested, while only a third of participants believed that the patients were not included in clinical trials without their consent.
Very small number of literature references can be found regarding the public awareness of CTs.Results of survey of 1000 healthy adults conducted by Coalition for Clinical Trials Awareness showed that 40% of surveyed adults do not understand clinical tri Results of survey of 1000 healthy adults conducted by Coalition for Clinical Trials Awareness showed that 40% of surveyed adults did not understand clinical trials [5].As main reasons for not wanting to participate in a clinical trial approximately half of the respondents gave concerns about treatment eff ectiveness or side eff ects (44%), mistrust of research organizations (20%), waiting for treatment approval (18%), and cost (15%) [5].Meta-analysis of qualitative studies showed that one of the motivating factors to participate in the CTs was the advice from general practitioner.6Participants also enrolled in CTs for reimbursement and free treatment [6,7].Nevertheless, it was noticed that awareness about CTs as a possible treatment option is extremely low, as seen in a study among cancer patients [8].Several studies showed that creating public awareness results in positive changes of public attitudes toward CTs and their enrolment, which ultimately leads to various benefi ts [8,9].Today, it is obvious that transparency, accountability and accessibility of CTs is crucial in order to re-establish public trust in CTs worldwide [10].
In many countries with developed clinical research practice there are associations for the promotion of clinical trials, with the aim to raise public awareness of the value of clinical research by developing information resources on clinical trials for patients and the public [11,12].For example, in Great Britain there is UK Clinical Research Collaboration which is promoting active patient and public involvement in clinical research.Work has included creating People In Research, a web resource for patients and the public, and recruiting patient/public members to advisory groups [13].Th e Center for Information and Study on Clinical Research Participation (CISCRP) from USA is a nonprofi t organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research and the role each party plays in the process [12].
Th e Agency for Medicines and Medical Devices of Montenegro took series of activities to enhance the awareness of professional and general public about clinical trials.Agency for Medicines and Medical Devices issued brochures on clinical trials intended for healthcare professionals and patients, organized two conferences and workshops for all potential participants in clinical trials.However, signifi cant eff orts for public awareness through workshops, seminars and mass media like programs on radio, TV, and write-ups in the print media are needed.
Increased awareness can lead to greater participation and consequently greater patient access to new therapies.

CONCLUSION
Th e study showed that the public awareness of CTs is low.Although highest ethical and scientifi c standards relating to procedure of clinical trials approval, conduct and monitoring have been implemented in Montenegrin legislation, results of this investigation indicate that additional educational eff orts are needed in order to improve the awareness and understanding of clinical trials.Th erefore, the Agency for Medicines and Medical Devices of Montenegro will continue its activities in order to promote clinical trials to the general and professional public.