2023年4月17日

2023年4月17日,阿历克斯基翁真实数据在生命科学的研究变得越来越重要。首席运营官Bruce Garett Rockville-based MediMergent称之为的“其他部门研究。“收集这些数据是在MediMergent使命,一个真实的数据收集和分析公司。工作与临床试验合作伙伴MediMergent挖到病人的行为数据为了收集了解药物的影响超出了疗效结果。尽管药物开发过程中的重要性,阁楼说病人在医疗最充分利用的资源。“真实世界数据缺失的一块。不只是一个昙花一现的想法。的现实如何遵循一个病人在治疗的过程中,”顶楼说。他补充说,现实世界的数据提供了一个更广泛的、更现实的观点如何一种药物在病人的工作。Garett解释说,临床试验通常排除基本信息,行为和态度等数据,或其他健康问题社会决定因素。 As an example, Garret recalled a clinical trial evaluating an experimental anticoagulant. The researchers overseeing the study were dutiful in collecting the data related to the administration of the test drug. However, they failed to consider patient behavior, such as the taking of aspirin during the study. Aspirin is often used as a blood thinner by people as a measure to mitigate cardiovascular disease risks. Combined with an anticoagulant drug, the use of aspirin increases the risks of bleeding concerns in patients. An examination of trial data did not reveal whether or not the use of aspirin was discussed with patients before beginning the study. Garret said 38% of patients revealed they took aspirin during the trial when directly asked. He said it is critical to talk with patients and ask these kinds of questions. Doing so provides what Garret and MediMergent calls “the voice of the patient.” The patient’s voice remains the most underutilized resource in healthcare, Garret said. Clinical trials have typically ignored the voice of the people when conducting research. That’s something MediMergent aims to address through its collaborations. “We connect the voice of the patient through surveys. We ask open-ended questions that will provide us with as much information as possible. The goal is to try and understand how they (the patients) really feel, how the medicines are making them feel. The drug may be doing its job but if they are so tired they can’t get out of bed for three days, we need to know that,” said Garret, a nephrologist by training. “The patient is the primary source for their own answers, it’s more direct and more efficient.” MediMergent most recently participated in a real-world data-focused study addressing the impact of COVID-19 on cancer patients. The study, conducted in partnership with AON, was sparked by the death of former U.S. Secretary of State Gen. Colin Powell, a cancer patient who died from COVID-19-related complications. Powell had both multiple myeloma and Parkinson’s disease. Although he was vaccinated against COVID-19, his body was unable to generate the appropriate levels of antibodies against the virus due to his compromised immune system. AON and MediMergent partnered on the EIMPRIS (Engaging Immuno-Protection Intervention Study) that was focused on the prevention of symptomatic SARS-CoV-2 infection in cancer patients. MediMergent applied its real-world data expertise to efficiently and economically collect, track and analyze high-quality patient-related data, Garret said. Using the patient perspective allows for medical professionals to more accurately meet patients’ needs, he added. The EIMPRIS trial, which was assessing a monoclonal antibody in immunocompromised patients as a prophylaxis against COVID-19 was halted by the FDA after the regulatory agency determined the drug was no longer effective against the most common strain of the SARS-CoV-2 virus. Before the study was halted, Garret said MediMergent saw a patient response rate of nearly 90% to its surveys gleaning real world data. “Patients have a vested interest in the responses they deliver. It means something to them,” he said. With interest somewhat waning in COVID-19 research, Garret said MediMergent will now turn its attention to the efficacy of different vaccines in patients with immune systems compromised by cancer. He suggested the company will examine vaccines for pneumonia and respiratory syncytial virus in these patients. Both disease indications disproportionately impact patients over the age of 60, and many of those people have been diagnosed with cancer. About the Author