Al-Azayzih Ahmad, Alzoubi Karem H
Department of Pharmacology and Therapeutics, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, United Arab Emirates.
Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid 22110, Jordan.
Int J Gen Med. 2020 Jul 2;13:337-342. doi: 10.2147/IJGM.S258260. eCollection 2020.
Clinical trials are an important tool to test the efficacy of new treatment modalities for cancer patients. Physicians, including medical residents, should play a major role in carrying out clinical trials to generate a strong body of evidence to determine the best available treatment for their patients. Carrying out clinical trials demands adequate understanding of the research phases and requirements including ethical standards as well as presenting positive attitudes toward the clinical research. Hence, evaluating the knowledge and attitudes of medical residents toward running clinical trials is essential to assess their preparedness and willingness to participate in future studies.
This study was a questionnaire-based observational study. It involved medical residents from various specialties who served cancer patients admitted at King Abdullah University Hospital during the period from June 1 to August 15, 2017.
A total number of 83 respondents completed the questionnaire. Of them, 56.7% and 53.0% of the respondents reported either current or previous participation in clinical trials research, respectively. Only 10 residents (12.0%) had previous participation in clinical research where a new investigational cancer treatment was tested. While, 91.6% of respondents believed that physicians should be involved in running clinical cancer research, only 25.3% had previous experience in writing a cancer clinical trial protocol and 28.9% wrote a scientific manuscript on cancer clinical trials for publication. Moreover, 67.5% of residents knew when informed consent should be obtained and 62.7% were aware of the clinical equipoise concept in clinical trials.
Much remains to be done to improve knowledge and attitudes of medical residents toward cancer clinical trials and the main ethical principles that should be followed to assure having an ideal research environment, which will pave the way for the generation of high quality clinical cancer research and reliable evidence-based clinical practice for cancer management.
临床试验是测试癌症患者新治疗方式疗效的重要工具。包括住院医师在内的医生应在开展临床试验中发挥主要作用,以生成强有力的证据,从而为患者确定最佳可用治疗方案。开展临床试验需要充分理解研究阶段和要求,包括伦理标准,并对临床研究持有积极态度。因此,评估住院医师对进行临床试验的知识和态度对于评估他们参与未来研究的准备情况和意愿至关重要。
本研究是一项基于问卷调查的观察性研究。研究对象为2017年6月1日至8月15日期间在阿卜杜拉国王大学医院为癌症患者提供服务的各专业住院医师。
共有83名受访者完成了问卷。其中,分别有56.7%和53.0%的受访者报告目前或以前参与过临床试验研究。只有10名住院医师(12.0%)以前参与过测试新型癌症研究性治疗的临床研究。虽然,91.6%的受访者认为医生应参与开展癌症临床研究,但只有25.3%的人以前有撰写癌症临床试验方案的经验,28.9%的人撰写过关于癌症临床试验的科学手稿以供发表。此外,67.5%的住院医师知道何时应获得知情同意,62.7%的人了解临床试验中的临床 equipoise 概念。
在提高住院医师对癌症临床试验的知识和态度以及确保拥有理想研究环境应遵循的主要伦理原则方面,仍有许多工作要做,这将为高质量的癌症临床研究以及基于可靠证据的癌症管理临床实践铺平道路。