PARTAKE Survey of Public Knowledge and Perceptions of Clinical Research in India

Abstract

BackgroundA public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE – Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program.ObjectiveTo study public knowledge and perceptions of clinical research.MethodsA 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India.ResultsInterviewees were 18–84 old (mean: 39.6, SD±16.6), 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware): ‘research benefits society’ (94.1%/3.5%/2.3%), ‘the government protects against unethical clinical research’ (56.7%/26.3%/16.9%), ‘research hospitals provide better care’ (67.2%/8.7%/23.9%), ‘confidentiality is adequately protected’ (54.1%/12.3%/33.5%), ‘participation in research is voluntary’ (85.3%/5.8%/8.7%); ‘participants treated like ‘guinea pigs’’ (20.7%/53.2%/26.0%), and ‘compensation for participation is adequate’ (24.7%/12.9%/62.3%).ConclusionsResults suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross-cultural surveys are required to inform educational programs addressing these issues.

Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research

“…The Indian clinical research environment has come under increased scrutiny by public activists and the media, and subsequently by the Indian Supreme Court for perceived unethical practices in the conduct of clinical trials (Table 1) [16,24,26,30,32,[36][37][38][39]. A report by the Indian Parliamentary Standing Committee identified an understaffed and under-resourced Central Drugs Standard Control Organization (CDSCO), including deficiencies in enforcing regulations, "collusion" with industry sponsors, and claims of exploitation of Indian citizens by foreign pharmaceutical companies [40].…”

“…A report by the Indian Parliamentary Standing Committee identified an understaffed and under-resourced Central Drugs Standard Control Organization (CDSCO), including deficiencies in enforcing regulations, "collusion" with industry sponsors, and claims of exploitation of Indian citizens by foreign pharmaceutical companies [40]. Lack of regulatory clarity and lengthy turnaround times for clinical trial approvals have deterred both local and foreign sponsors from conducting clinical trials in India and may have contributed to the reduction in the number of clinical trials in India since 2010 ( Figure 2) were deemed to contain data that were not meaningful) using the formula: [16] Indians are exploited by foreign and rich industry entities for financial gain [23].…”

“…The process is not "informed" and "consent" cannot be assumed; consequence of paternalistic model of health care [31] National Human Rights Commission [32], media [33,34], activists, PARTAKE survey [16] Addition of audio-visual recording to informed-consent process [35] Positive Medical knowledge Enhancing public health Surveys [16,27] Large majority endorses research…”

“…Voluntarism Surveys [16,27] Majority interested in participating in research Altruism Surveys [16,27] Majority endorses altruism as the only valid motivation to participate in research PARTAKE, Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment. all clinical research stakeholders gathered for the 2-day conference.…”

“…Fourteen participants were from the United States, the United Kingdom, Taiwan, and Saudi Arabia, and the rest were from India. The various attendees represented industry (56) healthcare (48), academia (40), NGO, public and patient advocacy (16), and regulatory (9) stakeholders.…”