Poongothai Subramani, Anjana Ranjit Mohan, Aarthy Ramasamy, Unnikrishnan Ranjit, Narayan K M Venkat, Ali Mohammed K, Karkuzhali Kulasegaran, Mohan Viswanathan
Department of Clinical Trials, Madras Diabetes Research Foundation, Chennai, Tamil Nadu, India.
Department of Diabetology, Dr. Mohan's Diabetes Specialities Centre and Madras Diabetes Research Foundation, Chennai, Tamil Nadu, India.
Perspect Clin Res. 2023 Jan-Mar;14(1):3-9. doi: 10.4103/picr.picr_161_21. Epub 2022 Jul 23.
A clinical trial is the most foolproof method to evaluate the efficacy of a new intervention. Successful completion of clinical trials depends on the retention of the participants enrolled. Poor participant retention can lead to significant time and cost burden and have potentially adverse biases on the results. A high retention rate of participants is an important criterion for the validity and credibility of randomized controlled clinical trials. Many long-term trials fail due to low retention of study participants. Efforts at participant retention should start even before the first participant is recruited into the study. Retention is not only the responsibility of the investigators but also all other stakeholders in a clinical trial. In recent years, retention materials, participant camps, and introduction of national study coordinators have helped in improving retention. Quality of the relationship developed between the research staff and the study participant is a key factor for success of any trial. In our experience, in the context of resource-challenged low- and middle-income countries, we have found that it is possible to achieve high retention rates, 95%-100%. The rapport built between the investigating team and the participant plays a vital role in retention. In addition, personalized care, including listening to the participant's problems and enabling to contact investigators or study team at any time of the day, has shown benefits in retention.
临床试验是评估新干预措施疗效最可靠的方法。临床试验的成功完成取决于所招募参与者的留存率。参与者留存率低会导致巨大的时间和成本负担,并可能对结果产生不利偏差。高参与者留存率是随机对照临床试验有效性和可信度的重要标准。许多长期试验因研究参与者留存率低而失败。在招募第一名参与者之前就应开始努力提高参与者留存率。留存不仅是研究者的责任,也是临床试验中所有其他利益相关者的责任。近年来,留存材料、参与者营地以及引入国家研究协调员都有助于提高留存率。研究人员与研究参与者之间建立的关系质量是任何试验成功的关键因素。根据我们的经验,在资源匮乏的低收入和中等收入国家,我们发现有可能实现95% - 100%的高留存率。研究团队与参与者之间建立的融洽关系在留存方面起着至关重要的作用。此外,个性化护理,包括倾听参与者的问题并使他们能够在一天中的任何时间联系研究者或研究团队,已显示出对留存率有帮助。