Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.
Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts.
Clin Ther. 2017 Nov;39(11):2196-2202. doi: 10.1016/j.clinthera.2017.09.010. Epub 2017 Oct 9.
Although there has been more involvement by patients in the drug-development process, there are not a lot of published data that quantify patient-centric activities or that document these activities across a large scale. In order to examine the patient-centricity landscape and to quantify the adoption and implementation of these initiatives, the Tufts Center for the Study of Drug Development and the Drug Information Association collaborated on a research study. The study examined patient-centric activities implemented by pharmaceutical, biotechnology, and contract research organizations, as well as activities being piloted or in the planning stages.
A global industry survey was conducted across pharmaceutical, biotechnology, and contract research organizations, assessing 25 patient-centric activities within clinical research. Some of these initiatives involve the use of social media to engage with patients, or the use of social listening to monitor study activity. Initiatives being implemented, planned, or piloted in addition to those not being considered were evaluated by respondents. Twenty-two unique companies responded to the survey, representing a mix of large, mid-sized, and small organizations.
The most widely adopted patient-centric initiatives, including activities both implemented and piloted across organizations, were patient advisory boards (17/22 companies), professional panels (16), lay-language clinical trial results summaries (13), assessment of the patient-organization landscape (10), and the use of home nursing networks (9).
The results of the study suggest that organizations have a varied approach to the adoption and implementation of patient-centric initiatives, with more activities occurring in the planning stages than are being piloted or implemented. Many factors affect implementation and adoption, including buy-in by senior management, organizational vision, resources, and level of investment.
尽管患者在药物研发过程中的参与度有所提高，但目前并没有很多已发表的数据可以量化以患者为中心的活动，或记录这些活动在大范围的开展情况。为了考察以患者为中心的活动的现状，并量化这些举措的采用和实施情况，塔夫茨药物开发研究中心与药物信息协会合作开展了一项研究。该研究考察了制药、生物技术和合同研究组织实施的以患者为中心的活动，以及正在试点或规划阶段的活动。
对制药、生物技术和合同研究组织进行了全球范围的行业调查，评估了临床研究中 25 项以患者为中心的活动。其中一些举措涉及使用社交媒体与患者互动，或使用社会监测来监测研究活动。受访者对正在实施、计划或试点的举措以及未被考虑的举措进行了评估。22 家独特的公司对调查做出了回应，这些公司既有大型公司，也有中型公司和小型公司。
最广泛采用的以患者为中心的举措，包括已在各组织中实施和试点的活动，包括患者顾问委员会（22 家公司中的 17 家）、专业小组（16 家）、通俗易懂的临床试验结果摘要（13 家）、评估患者组织情况（10 家）和使用家庭护理网络（9 家）。
研究结果表明，各组织对以患者为中心的举措的采用和实施采取了多样化的方法，处于规划阶段的活动多于试点或实施阶段。许多因素会影响实施和采用，包括高层管理人员的认可、组织愿景、资源和投资水平。
