影响参与新药试验研究意愿的因素：一项针对加纳北部将孩子招募进此类试验的家长的研究。
Factors influencing willingness to participate in new drug trial studies: a study among parents whose children were recruited into these trials in northern Ghana.
作者信息
Akazili James, Chatio Samuel, Achana Fabian Sebastian, Oduro Abraham, Kanmiki Edmund W, Baiden Frank
机构信息
Navrongo Health Research Centre, P.O Box 114, Navrongo, Ghana.
Ensign College of Public Health, ER, Kpong, Ghana.
出版信息
BMC Res Notes. 2016 Mar 3;9:139. doi: 10.1186/s13104-016-1951-4.
BACKGROUND
During the last decade, the number of clinical trials conducted in sub-Saharan Africa has increased significantly which has helped to address priority health problems in the region. Navrongo health research centre since it was established in 1989, has conducted several trial studies including rectal artesunate trial in the Kassena-Nankana districts. However, there is little evidence-based for assessing the impact of new drug trials. This study explored factors that motivate parents to allow their children to participate in new drug trials in northern Ghana.
METHOD
The study used both quantitative and qualitative methods. The participants were randomly selected from among parents whose children were enrolled in a new drug trial conducted in the Kassena-Nankana districts between 2000 and 2003. QSR Nvivo 9 software was used to code the qualitative data into themes before analysis while STATA software Version 11.2© was used to analyze the quantitative data.
RESULTS
The results showed that majority (95.9%) of the parents were willing to allow their children to be enrolled in future new drug trials. The main factors motivating their willingness to allow their children to be enrolled in these trials were quality of health care services offered to trial participants (92.9%), detail medical examination (90.8%), promptness of care provided (94.4%) and quality of drugs (91.9%). Other factors mentioned included disease prevention (99.5%) and improved living standard (96.1%). Parents reported that the conduct of these trials had reduced the frequency of disease occurrences in the communities because of the quality of health care services provided to the children recruited into these trial studies.
CONCLUSION
Though the implementation of clinical trials in the study area is believed to have positive impact on health status of people particularly trial participants, measures should however be taken to address safety and likely side effects of new drugs given to trial participants during these trial studies.
背景
在过去十年中，撒哈拉以南非洲地区开展的临床试验数量显著增加，这有助于解决该地区的重点健康问题。纳瓦龙戈卫生研究中心自1989年成立以来，开展了多项试验研究，包括在卡塞纳-南卡纳地区进行的青蒿琥酯直肠给药试验。然而，评估新药试验影响的循证依据很少。本研究探讨了促使加纳北部家长允许其子女参与新药试验的因素。
方法
本研究采用了定量和定性方法。参与者是从2000年至2003年在卡塞纳-南卡纳地区参加新药试验的儿童的家长中随机选取的。在分析之前，使用QSR Nvivo 9软件将定性数据编码为主题，而使用STATA软件版本11.2©分析定量数据。
结果
结果显示，大多数（95.9%）家长愿意让他们的孩子参加未来的新药试验。促使他们愿意让孩子参加这些试验的主要因素是为试验参与者提供的医疗保健服务质量（92.9%）、详细的医学检查（90.8%）、提供护理的及时性（94.4%）和药品质量（91.9%）。提到的其他因素包括疾病预防（99.5%）和生活水平提高（96.1%）。家长们报告说，由于为参与这些试验研究的儿童提供了高质量的医疗保健服务，这些试验的开展降低了社区疾病发生的频率。
结论
尽管据信在研究地区开展临床试验对人们尤其是试验参与者的健康状况有积极影响，但仍应采取措施解决在这些试验研究期间给予试验参与者的新药的安全性和可能的副作用问题。
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