Bardakjian Tanya M, Naczi Kaylee Faulkner, Gonzalez-Alegre Pedro
Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
Raymond G. Perelman Center for Cellular & Molecular Therapeutics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
J Huntingtons Dis. 2019;8(1):79-85. doi: 10.3233/JHD-180328.
Advances in molecular therapeutic approaches in the last decade are translating into the design of non-traditional clinical trials. In order to improve their feasibility, it is important to understand the attitudes of potential participants towards these trials, their motivations to get involved and acceptance of risks.
We aimed to better understand the willingness of potential participants to participate in different molecular therapy trials for Huntington's disease (HD) based on their clinical and genetic status, trial design and goals of the treatment.
An anonymous survey was distributed through the Huntington's Disease Society of America (HDSA) on-line portal/website. Various hypothetical scenarios were presented followed by a survey consistent of Likert scale responses ascertaining willingness to participate, collecting demographic, clinical and genetic information.
There were a total of 87 responses, including patients diagnosed with HD, pre-manifesting mutation carriers and asymptomatic participants at risk. The majority of participants indicated they were very likely or likely to participate in clinical trials independent of study design or goals of the therapy, with a more favorable view in premanifesting mutation carriers. However, more invasive procedures and trials including placebo were less favorably viewed across all diagnostic groups.
In summary, most individuals in the HD community would consider participation in novel molecular therapy trials, but study design and goals could impact patient recruitment. This data can be used to inform the recruitment and consent process into clinical trials and to address common concerns by potential participants.
过去十年中分子治疗方法的进展正在转化为非传统临床试验的设计。为了提高其可行性,了解潜在参与者对这些试验的态度、参与的动机以及对风险的接受程度非常重要。
我们旨在根据潜在参与者的临床和基因状况、试验设计以及治疗目标,更好地了解他们参与不同的亨廷顿舞蹈病(HD)分子治疗试验的意愿。
通过美国亨廷顿舞蹈病协会(HDSA)的在线门户网站/网站进行了一项匿名调查。呈现了各种假设情景,随后进行了一项调查,该调查由李克特量表回答组成,用于确定参与意愿、收集人口统计学、临床和基因信息。
总共收到87份回复,包括被诊断患有HD的患者、症状前突变携带者以及有风险的无症状参与者。大多数参与者表示,无论研究设计或治疗目标如何,他们非常可能或有可能参与临床试验,症状前突变携带者的看法更为积极。然而,在所有诊断组中,对侵入性更强的程序和包括安慰剂的试验的看法不太积极。
总之,HD群体中的大多数人会考虑参与新型分子治疗试验,但研究设计和目标可能会影响患者招募。这些数据可用于为临床试验的招募和知情同意过程提供信息,并解决潜在参与者的常见担忧。