|Year : 2012 | Volume
| Issue : 4 | Page : 125-132
Public awareness of clinical trials: A qualitative pilot study in Pune
Veena Joshi, Aditi A Kulkarni
Department of Research, Deenanath Mangeshkar Hospital and Research Centre, Pune, India
|Date of Web Publication||19-Nov-2012|
Department of Research, Deenanath Mangeshkar Hospital and Research Centre, Pune - 411 004
Source of Support: Deenanath Mangeshkar Hospital & Research Centre, Pune, Conflict of Interest: None
| Abstract|| |
Context : Medical expertise combined with availability of patients with varied diseases have resulted in rapid increase in number of clinical trials (CTs) recruiting millions of patients in India. Yet, few researchers have tried to understand if the public in India is aware of CTs. Aims : To explore the awareness, perceptions of and attitude towards participating in CTs among general public in Pune. Materials and Methods : Focus group discussions (FGDs) and interviews were conducted by contacting people in the community of various age groups and socio economic status with 7 Trial participants (TPs) and 17 Non Trial Participants (NTPs). The survey tool consisted of open-ended questions that assessed the awareness and attitudes of the individuals regarding the CTs. Interview were recorded on paper and translated from (Marathi) local language to English for analysis. Qualitative analysis was used to report the findings. Results : Most participants could associate CTs with medicine or development of new medicine; however they did not have a good understanding of the manner and safeguards with which CTs are conducted. Participants were not aware about different types of CTs and phases of the CTs. CTs were felt to be of benefit to the community and advancement of science. However, due to fear of adverse effects, 80% of the respondents were not ready to participate in the CTs. Conclusions : The Indian Pharmaceutical company is the world's 3 rd largest by volume as per Dr. Shivathanu Pillai's report 17th March 2010, in spite of that it has been noticed that the awareness about CTs is very low; therefore there is a need to create awareness about CTs which helps the participants to participate in CTs based on their own decision. These FGD findings require validation in a larger sample.
Keywords: Attitude, awareness, clinical trial, focus group discussions, public, perceptions
|How to cite this article:|
Joshi V, Kulkarni AA. Public awareness of clinical trials: A qualitative pilot study in Pune. Perspect Clin Res 2012;3:125-32
| Introduction|| |
India has the largest pool of patients suffering from cancer, diabetes, metabolic syndrome, and other maladies. Furthermore, due to low costs, medical expertise and good hospital facilities, many Multinational Companies are conducting several trials in India recruiting several thousands of Indians.  Several articles talk about increase in number of clinical trials (CTs) and revenues but few talks about "Trial Participants (TPs)" who contribute to the advancement of science and to the revenue. Few researchers have looked at whether the TPs who get recruited in CTs are aware of what CTs are and if participation agreement is purely their conscious decision. Studies have made known that fear, distrust or suspicion of research, apprehension and scepticism could hinder awareness about the CTs, especially among minorities.  Language and literacy barriers may make it difficult for some people to understand which may be the main barrier for awareness.
In the west, studies have been carried out with cancer patients about their awareness of CTs mainly because of recruitment difficulties but few researchers have tried to find out general public awareness of CTs. In India, it is hard to find literature on such topics. Thus, this study has used references from the west. A study conducted with South Asian Patients in Briton had identified motivators for participating in the trials as, improve own as well as family and friend's health, help to the society and increase in scientific knowledge.  The same study had reported the deterrents as concerns of drug side effects, language barriers, previous bad experiences, mistrust and feeling of not belonging to British society.  Another study by Hussan-Gambles reported barriers to participate in CT were trial burden, mistrust with health workers and language barriers.  Catanica in his study with Italian patients reported the deterrents as prejudices, and fear that doctors were interested in advancing their own research, even though there were more efficient drugs available.  All these instances point out that awareness of clinical trial may increase conscious motivation to participate.
According to New Mexico Cancer Care Alliance, lack of awareness of CTs hinders patients' participation in cancer trials.  A survey of almost 6,000 people with cancer showed that 85 percent of people with cancer were either unaware or unsure that participation in CTs was an option, though 75 % of these people said they would have been willing to participate. 
Many times researchers do not try to make the public aware by not displaying the relevant information about their study. Giuliano's study on participation of minorities in cancer research found that while some minority women were reluctant to join research studies, the others lacked the information necessary to explore these options.  Some are never offered the information, while others lack the scientific framework needed to make an informed decision.  Providing resources to help individuals make informed decisions about research involvement promotes understanding of the true benefits and risks of participation in CTs. It also increases awareness about the importance of CTs. 
Use of qualitative research is popular in CTs. Qualitative methods involve an in-depth exploration of a phenomenon. Qualitative research is concerned with the opinions, experiences and feelings of individuals producing subjective data collected through direct encounters with individuals, through one on one interviews or group interviews or by observation  and facilitate research focusing on cultural issues and diverse ethnic populations like India. Thus, the use of focus group methodology was anticipated to allow the research team to gain insight into participants' beliefs and attitudes about CTs and a medium for their voices to be heard. Since the discussions are in respondents' own verbatim, FGD and interviews generate information that helps to tailor health educational tools with appropriate cultural content and language. Focus group methodologies are essential when there are differences in perspectives or views between researchers and the communities they are targeting.  Allison Tong  has developed a check list for comprehensive reporting of qualitative studies. We tried to follow this consolidate criteria for our study.
The Need for Awareness of CT: National Institute of Health in the US (NIH) website has mentioned that people need to consider how they can help advance the prevention, diagnosis, and treatment of disease. It is never too early to consider participation whether or not someone ultimately chooses to join a study  making public aware about CTs is advantage for the participant as well as for the investigator. Participant's awareness is necessary to know the availability of CTs so that those who cannot afford the treatment or when there is no alternate treatment available for the disease, one can get benefited by participating in a CTs. Harris Interactive Survey, 2001 had indicated that awareness changes attitudes toward CTs, enrollment, and the benefits of participation. 
If participant is aware of the manner of conduct of a CT he/she would participate with an informed decision, recruitment will be easy and retention rate will be high. When participants are aware, compliance will increase giving better trial results. This would help the investigator for smooth conduct of a CT. Although there is an extensive literature ,, evaluating the factors promoting and precluding participation in CTs among various populations, there are a limited number of studies that focus on understanding the awareness, perceptions and attitudes to participate in CTs. The aim of this study is to explore the awareness, perception and attitude towards participating in CTs among the general public in Pune. There is an urgent need to find the public level of awareness about CTs, which will help in planning and conducting, targeted population specific education programs.
| Materials and Methods|| |
Convenience sampling was used to recruit participants. None of the participants refused to participate. Participants who were friends or relatives of patients at outpatient department at a tertiary Hospital in Pune were approached face to face or by telephone. Participants were asked about their age, level of education and occupation in addition to questions about CT such as what was the source of information about CT, what did they know about CT, were they aware that participant's consent is taken before participation and what is consent and when to give consent and if they are willing to participate. Trial Participants were asked how was the participant's experience with the CT, why did they participate, would he/she participate again in CT etc. Graduate and above level of education was treated as higher level of education. The interviews and FGD's were conducted at Department of Research office during Nov and Dec 2011 by contacting people of various age group and socio economic status from Erandawane area in Pune. The interviews were conducted with Trial participants (TPs) and FGD's and interviews were conducted with Non Trial Participants (NTPs).
One-on-one interviews were conducted where discussion between one interviewer and one TP took place.
Focus group discussions (FGD)
Were conducted with small group gatherings (8-10 people per session) where the materials and messages were discussed in a group setting. The authors approached individuals and briefly informed them about the study, which was to assess individual's knowledge, attitudes and behaviour regarding CTs. All interviews were conducted in English and Marathi language. The interviewers were authors, who had no prior relationship with the individuals participated in this study. Interview lasted approximately 30-45 min and were recorded on paper and translated into English for analysis.
The survey tool consisted of open ended questions that assessed the awareness and attitudes of the individuals regarding the CTs, their perceptions about CTs and their willingness to participate in different types of CTs, (e.g. Drug trial, device trial etc. if they would participate in CT), and informed consent document.
NTP: One FGD was conducted with six people and 11 people were interviewed (nine women and seven men; age ranged from 27 to 71 years). Education level was graduate and above graduate.
TP: Seven people (four men and three women) who had completed the trial were interviewed (age ranged from 50 to 70 years). Education level was graduate and above graduate.
Findings generated from these interviews can be used to develop the questionnaire for evaluating public and the patient's perception, awareness, attitudes and behaviour regarding CTs participation in the next project.
We did not apply for approval from Institutional Ethics Committee, as we conducted qualitative study with public with the intension of designing a questionnaire for quantitative study based on FGDs and interviews only. No personal identifiers, clinical information or sensitive questions were asked to the participants. However, this manuscript was reviewed and approved by Deenanath Mangeshkar Hospital and Research Centre (IEC_DMHRC).
| Results|| |
After each FGD and interviews, the researchers reviewed their field notes from the discussion and highlighted comments that were offered, and then clustered the comments into themes.
Themes for each of the FGD and interviews were collated. The results are shown in [Table 1] and [Table 2].
The first theme focused on respondents' awareness of CTs and source of information of CTs.
For the second theme were reasons for participation in the CTs.
For the third theme was their knowledge of Informed consent form (ICF).
The fourth theme was their overall experience with the CTs.
For the fifth theme was respondents informed their attitude towards participation in a CTs.
Sixth theme discribed the risks and benefits of CTs as perceived by the respondents.
The seventh theme was advise others to participate in a CTs
The eighth theme was Necessary to create awareness about CTs.
The Ninth theme was how to create awareness of CTs among general public.
The main themes generated from the qualitative research were, importance of first contact point i.e. principal investigator (P.I) / person in CTs recruitment, and most (90%) participants believed on their P.I.'s decision.
- Awareness of CT: About 90% of NTP agreed that they knew nothing about CTs and they were not inquisitive to find out about CTs. Among NTP, the awareness about CTs was very low only 18% people knew the term CTs and 82% of the respondents were unaware about CTs. Two out of 17 NTPs said that CTs should be conducted only on terminally ill patient and one NTP said CTs should be conducted only on healthy people. 16 out 17 NTPs were not familiar with device trial; also they were not aware of types and phases of CTs. While our FGD showed that 86% of TPs were aware about CT and 14 % of them were unaware about CTs and 28.57% TPs were not aware who will sign for child who participated in CTs. This shows that overall public awareness about CTs was poor.
- Source of information about CTs: TPs got the information about CTs mainly from their physician (72%) and the other sources were friends and relatives (14% each).
- The main reason of participation in CTs: It was doctor's advice (70%). The other reasons were the drug may be useful for curing their disease and just wanted to try it out (15% each).
- Attitude towards participation in CTs: 15% of TPs were not willing to participate in any study in future but thought that people should volunteer for the benefits of others while 15 % said they will participate even if their family member and close friends object. The same percentage of people (15%) said that they will participate only if their family members have no objection. These participants pointed out that "their family member's opinion was valuable for them". Remaining 55% said they will participate and they perceived that "people should participate in CT". 20% of NTPs stated that they will participate after discussing the risks involved with their family members. One NTP declared that he will decide to participate after discussing with others who had already participated in the study. 9% of NTPs thought that they will be doing favour to the doctor by participating in CTs. 80% of the NTPs were worried about the adverse events and therefore they had made a decision of not participating in a CT. 91% TPs were concerned about the compensation. They would participate only after getting assurance from the investigator. Only 9% each said that they will participate for a noble cause and advancement of science.
- Knowledge of Informed Consent Form: All the NTPs had no knowledge of Informed Consent Form (ICF).
- Among TPs, 85% of participant had signed the ICF while 15% were not aware of the term ICF and were unaware of what document they had signed. All of them said there must be transparency in the ICF and signing should be a must for all kind of studies.
- CTs experience: 15 % of TPs revealed that the overall CT experience was not very good. It was very time consuming and they had to travel far away distance. For 15 % of the participants, the experience was very painful and they had to withdraw from the trial. While for (70%) of the respondents, the CTs experience was good. They got free medicine, free check up and free transportation, their health status improved, they received more attention from the doctors, and furthermore they were satisfied with all study team members and said study team was co operative and helpful.
- Risk and Benefits of CTs: Among NTP 80 % felt that it is risky to participate in trial because drug is still in trial phase and at this stage, no one knows the side effects. 20% thought participation in phase 1 and phase 2 CTs is risky while 30% of them believed that CTs is beneficial to science. 9% assured that one can get more accurate results by conducting CTs. 20% were convinced that CTs is the only way to evaluate side effects of the drug. Remaining NTPs were neutral as they were totally unaware about CTs. Among TPs, 15 % of them were scared of the side effects. One of the female participants expressed her feelings by saying "I do not want to be a sample for them; I don't want to risk my life. I love my life and my opinion is fair." 15% TP did not know of any risk that is caused by participating in CTs as they had never experienced or have heard about the risk of CTs while 15% said that there is no risk involved in CTs and trial participants were not treated as guinea pigs. These TPs felt that every medicine has side effects whether it is study drug or a marketed drug. Remaining 55% TPs voiced their opinion by saying that risk depends on study drug as well as on the treating doctor. There were mixed reactions about the benefits of CTs. 65% of TPs felt that CTs are beneficial because doctor gives more attention to the trial participants, and participants get free medication, treatment and transportation. However 15% of the respondents said CTs is not beneficial to the participants but beneficial to the Pharma Company; and, one male TP perceived it as money making business. According to 15 % participants, giving free treatment and medication is bribing. 15% of the participants demanded that when the drug comes into the market, it should be given free or at least at reasonable cost to the TP.
- Would you advise others to participate in CTs? 40% of TPs stated that those who want to participate should know the implications of the trial. 40% felt that let people decide on their own if they want to participate or not. 20% of TPs were ready to be an advocate for other participants so that they can participate in CTs.
- 75% of NTPs said that they always advice their close friends and relatives to participate in CTs, if doctor is very sure and previous trial results are available. 9% said that they will reveal the complete picture to the participants and then let them weigh the options. 18 % of participants did not want to advice any one to participate in CTs.
- Necessary to create awareness about CTs: 90% NTPs said that awareness should be created among all, at least from 12 th standard of education onwards. 80% of the participants suggested that awareness must be created in such way that fear must be removed from everybody's mind.
- 70% of TPs said awareness is necessary while 30% did not feel that there is a need to create awareness among public. According to these 30% respondents, public gets bored due to this awareness programs and felt that one can become aware from their own experience of participation in a CT.
- How to create CTs awareness: Mouth publicity (70%), TV and Radio (95%), documentary and short films (35%), print media publicity (20%) conducting lecture in colleges, presentation for community (15%) were some of the ideas to create awareness.
| Discussion|| |
As seen in this study, focus groups and interviews have generated information that helped us to understand the beliefs and views of the general public as well as the TPs regarding CTs and the related issues. The results of our study indicated that there is low awareness about CTs among the general public. It was noticed that despite the high education level of our sample, many still had difficulty understanding basic concept of CTs. Few TPs were unsure about what documents they had signed. Although CT aims to provide a high standard of care and help contribute to increased scientific knowledge only a relatively small proportion of patients received treatment as a part of formal CTs. From our study it is seen that selection of TPs was often based on level of patient - doctor-patient's relative relationship and trust. Our study showed that the patients entered the CTs because of their primary care physician. When the trial's principal investigator is also the patient's primary physician, there is scope for a direct conflict of interest, especially if physicians are paid recruitment fees to recruit their patients into trials.  Results from Breast Cancer study showed that a recommendation by their physician was the primary factor influencing patients' decision to enrol in a trial. If the patient must be referred elsewhere to participate in a trial, doctors fear they may lose control over the patient's care.  For the same reason, doctors are reluctant to refer their patients to a trial conducted by another doctor.  This keeps the patients away from the trial information. FGD conducted in North Carolina with cancer patients reported that personal relationship of the patients with the staff influenced their decision to volunteer and their willingness to participate. Participant's decision was also based on cues that caught their eyes (after reading news paper ads), ears (recommendations by someone), and attention (personal or family health issues).  The same results are seen in our FGD. One of the study conducted by SM Madsen in year 2002 suggested that trial participants as compared with non participating respondents were, more positive towards both participation of self and others,  our evaluation about TPs' attitude showed similar results. Study conducted by Barrie R showed that most respondents (71%) believed that patient should serve as research subjects.  In support of this belief, the majority of the respondents from our study cited potential benefit to others and the opportunity to increase scientific knowledge, but the difference bias emerged when we asked them about their own potential participation. Altruistic attitude was observed among participants of this study which is consistent with other ethnic groups from Briton  and Rheumatoid Arthritis patients in California.  Participants of this study depended on their family members or friends to guide the decision of their own participation which is consistent with the dependency issues mentioned by Shah in his Meta-analysis of Qualitative studies. 
In our study, all NTPs and few TPs were unaware of the term inform consent. Similar result was reported by the focus groups conducted with 33 African American adult patients where the results revealed that few participants had understood concept of informed consent. 
In the same study  and the studies reported in Briton , the patients had expressed distrust with the medical community. Also participants expressed fear that the doctors could and would make statements to persuade people to participate in the research. , In our study distrust was expressed only with the Pharma companies.
The results of our study offered us a chance to compare the levels of awareness of trial and non-trial participants using trial participants as a control. Our findings require validation in a larger sample that includes other geographical areas in the country. The findings generated from these interviews will then be used to develop the questionnaire for evaluating public and the patient's perception, Knowledge, attitudes and behaviour regarding CT participation in the next project. Also the study would help in modelling culture specific education programs for the masses regarding phases and types of CTs, conduct of CTs, risks and benefits involved in the trials, and participant's rights while participating in CTs by understanding the importance of informed consent form. This education would in turn help people make better informed decisions and choices regarding participation in trials (it would be a self-initiated participation rather than an "influenced" participation). Awareness about CTs should reduce exploitation of TPs by Multinational Companies (MNCs).
There were a number of limitations to this study. This study was not conducted on a random sample. This study was conducted in a particular location (Our sample was limited to one geographic area of the city) leading to a biased sample. Data was collected from few individuals so findings cannot be generalized to a larger population. The education level of the respondents was higher as compared to the general public. Despite these weaknesses, there are some strengths. The response rate for the study was 100% offering opinions about clinical trials. This is one of the few studies in India, where information has been gathered to understand awareness, perceptions and attitudes about clinical trials.
The awareness of CTs was low even among fairly well educated respondents of our study. Considering that 70% of India's population is rural, there is an urgent need to look at awareness of CTs.
| Conclusion|| |
From focus group discussions and interviews participants revealed that the awareness of CTs is low. Participation was highly based on physician's trust. Willingness to participate in CTs was not very high among the public. It was more among TPs as compared to NTPs and those who are willing, wanted to participate for noble cause. Conducting a quantitative study with a large sample should validate the results of this study.
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[Table 1], [Table 2]
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