A Comparative, Multi Centric, Cross-sectional Study Of Perception and Awareness of Clinical Research In Trial Participants and General Public of AP

 Clinical research helps us determine the safety and efficacy of medications, devices, diagnostic products intended for human use.  The design and conduct of the trial is dictated by the protocol & approved by regulatory authorities  The data thus collected is scientifically analyzed to reach a valid inference  The most challenging area in Clinical Research is : finding eligible and compliant subjects for willful participation.

Important steps in clinical research  Public should know  Public should understand  Public should participate

Current public understanding of clinical research is poor and media coverage of clinical research trials is often negative Bartlett C, Sterne J, Egger M

There is agreement in the literature that one of the major barriers to recruitment and enrollment of patients in clinical trials is patients' lack of awareness about clinical trials. Isla S Mackenzie, Li Wei, Daniel Rutherford et al

Responses differed neither by subgroup nor by demographic variables. {104 cancer pts, 84 cardiology pts, and 107 general public} Most respondents (71%) believed that patients should serve as research subjects Cassileth BR, LuskEJ, Miller DS, Hurwitz S

 Results suggest the Indian public is aware of some key features of clinical research like: purpose/ value/ voluntariness and supports clinical research in general  But is unaware of other key features like: Compensation/confidentiality/protection of human participants &  Exhibits some distrust in the conduct and reporting of clinical trials PARTAKE Survey of Public Knowledge and Perceptions of Clinical Research in India (Delhi)

 Trial participants were, as compared with nonparticipating respondents, more positive towards both participation of self and others.  Both personal and altruistic motives for participation were highly rated.  Primary reasons for nonparticipation were *fear of ‘the unknown’ and/or *unease with randomization Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P (Copenhagen University )

1)Awareness changes attitude toward clinical research 2) Helps participant make an informed decision 3) Improves overall trust in the clinical research

 To determine the areas in which there is LACK of perception & awareness of clinical trial in both groups (TP) & (NTP)  To determine the areas in which there is GAP of perception & awareness of clinical trial between both groups (TP) & (NTP)  To determine ways and means for bringing about better awareness in both groups {{TP—trial participants, NTP----non trial participants}}

 Protocol was designed and an approval from Institutional Ethics Committee was taken  Sample size was calculated and found to be 165 in each group. { Assuming 70% of awareness with 95% of confidence interval (C.I), 20% relative precision with a design effect of 2}.  Designed a Questionnaire and EC approval taken  Recruitment process discussed for TPs and NTPs  Data collection procedure finalised  Statistical Analysis discussed

RESULTS

LITERACY TPNTP Illiterate9% 1-12 class61% Graduate30% COMPARABLE GROUPS

PurposeTPNTP Help in Research74%57% Financial Benefit21%32% Others5%11% Source of InformationTPNTP Friends/ Relatives/ Participated subject 81%53% Advertisements5%16% Others (Doctors etc…)13%28%

Awareness TP NTP Medicines using today were part of clinical trials earlier 85%60% Clinical research an essential step for developing new treatment of diseases 86%62% Trials conducted globally for better treatment of diseases88%60% Many people participating in clinical trials all over the world89%54% Confidentiality of the participants personal information will be maintained 97%47% Drugs tested thoroughly for its safety before using it97%62% Leaflet that comes with medicine prepared based on clinical trial results 89%53% Pharmaceutical companies spend billions of rupees on clinical research 91%53% Take years for a drug to come into market81%61% Surveillance by regulatory bodies even after the drug approval74%42%  Awareness on Clinical Research

 Awareness on Elements of Consent Form  Participation se with Audio-Video Consenting  TP- 56% Believe  NTP- 73% Don’t believe TP=Trial Participants; NTP=Non-Trial Participants (General public).

 Ethics Committee TP=Trial Participants; NTP=Non-Trial Participants (General public)

 Financial transaction TP (%)NTP(%) Food and transport3437 Reward for participation3341 Transport, food and reward for participation 12- Transport, food and others14- Others722

 Awareness on Risks Vs Benefits TP=Trial Participants; NTP=Non-Trial Participants (General public)

 Knowledge on who will be the beneficiary in Clinical Trials BeneficiaryTPNTP Participants 7%13% Pharmaceutical company 12%36% Society 70%49% Society and Pharmaceutical company 6%2% Society and participants 5%-

 Source of Information:  Awareness on Risks and Benefits  Need to create awareness: Pune: 97%; Hyderabad: 81% Hyderaba d Pune Friends/ Relatives/ participated subjects 81%28% Doctors / Clinics13%72% Hyderaba d Pune Risks involved in clinical Research93%60% Benefits in clinical Research95%75%

According to our survey it was concluded that the awareness on clinical research is low in our society especially in the areas of: 1) elements of consent form and consenting process, 2) Confidentiality in Clinical Research 3) Regulatory machinery of the clinical research.