1Sanaria, Inc., Rockville, Maryland.
2Department of Family Medicine, John Peter Smith Hospital, Fort Worth, Texas.
Am J Trop Med Hyg. 2020 Nov 23;104(2):695-699. doi: 10.4269/ajtmh.20-1178.
Providing medical care for participants in clinical trials in resource-limited settings can be challenging and costly. Evaluation and treatment of a young man who developed cervical lymphadenopathy during a malaria vaccine trial in Equatorial Guinea required concerted efforts of a multinational, multidisciplinary team. Once a diagnosis of diffuse large B-cell lymphoma was made, the patient was taken to India to receive immunochemotherapy. This case demonstrates how high-quality medical care was provided for a serious illness that occurred during a trial that was conducted in a setting in which positron emission tomography for diagnostic staging, an oncologist for supervision of treatment, and an optimal therapeutic intervention were not available. Clinical researchers should anticipate the occurrence of medical conditions among study subjects, clearly delineate the extent to which health care will be provided, and set aside funds commensurate with those commitments.
在资源有限的环境中为临床试验的参与者提供医疗护理可能具有挑战性并且成本高昂。在赤道几内亚进行的疟疾疫苗试验中,一名年轻男子出现颈部淋巴结病,需要一个多国家、多学科团队的协同努力。一旦做出弥漫性大 B 细胞淋巴瘤的诊断,该患者就被送往印度接受免疫化疗。这个病例表明,在一个没有正电子发射断层扫描用于诊断分期、没有肿瘤学家监督治疗以及没有最佳治疗干预的环境中进行的试验中,如何为发生的严重疾病提供高质量的医疗护理。临床研究人员应该预料到研究对象中会出现医疗状况,明确界定将提供的医疗保健范围,并留出与这些承诺相符的资金。