Joshi Veena D, Oka Gauri A, Kulkarni Aditi A, Bivalkar Varada V
Department of Research, Deenanath Mangeshkar Hospital and Research Centre, Pune, Maharashtra, India.
Perspect Clin Res. 2013 Jul;4(3):169-74. doi: 10.4103/2229-3485.115378.
Studies have reported that clinical research has experienced tremendous growth during past few decades with many multinational pharmaceutical companies recruiting millions of Indians in clinical trials (CTs). However, there is hardly any literature that talks about the participants, their knowledge, and awareness of CTs. It is important that the general public is aware about CTs so that they can take their own informed decision to participate in CTs.
To assess public awareness, perceptions, and attitudes toward CTs and their views on various methods to create awareness about CTs.
Cross sectional survey was conducted with 200 non trial participants (NTPs) and 40 trial participants (TPs).
TPs were significantly (P < 0.0001) older than NTPs. More than 80% of both TPs and NTPs mentioned participation in CT helps advance medical science and strongly felt that there is a need to create awareness about CTs. Nearly 70% of TPs could not remember the phase of the trial while 20% did not know which type of trial they had participated. The main reason for participation in the trial was physician's advice. About 80% of both TPs and NTPs felt that participation in CT will increase with free medications and advice from friends/relatives who had good experience with trial.
Results of this pilot study revealed need to create CT awareness among the general public. However, considering ethno-cultural, regional, and literacy-level differences throughout the country, a nationwide study would be appropriate to provide reliable results about awareness of CTs among Indians.
研究报告称,在过去几十年中临床研究经历了巨大的增长,许多跨国制药公司在临床试验中招募了数百万印度人。然而,几乎没有任何文献谈及参与者、他们对临床试验的了解及认识。普通公众了解临床试验非常重要,这样他们才能做出明智的决定是否参与临床试验。
评估公众对临床试验的认识、看法和态度,以及他们对提高临床试验认识的各种方法的看法。
对200名非试验参与者(NTP)和40名试验参与者(TP)进行了横断面调查。
试验参与者的年龄显著大于非试验参与者(P < 0.0001)。超过80%的试验参与者和非试验参与者都提到参与临床试验有助于推动医学发展,并强烈认为有必要提高对临床试验的认识。近70%的试验参与者记不起试验阶段,20%的人不知道自己参与的是哪种类型的试验。参与试验的主要原因是医生的建议。约80%的试验参与者和非试验参与者认为,免费药物以及有过良好试验体验的朋友/亲戚的建议会使参与临床试验的人数增加。
这项初步研究的结果表明有必要在普通公众中提高对临床试验的认识。然而,考虑到全国各地的民族文化、地区和识字水平差异,进行全国性研究以提供关于印度人对临床试验认识的可靠结果将是合适的。