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    Home > Biochemistry News > Biotechnology News > Nature Sub-Journal: COVID-19 Affects Global Cancer Clinical Trials

    Nature Sub-Journal: COVID-19 Affects Global Cancer Clinical Trials

    • Last Update: 2020-06-17
    • Source: Internet
    • Author: User
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    Between March 23 and April 3, 2020, CRI and IQVIA conducted questionnaires and written interviews with key researchers in 36 cancer clinical trials around the worldIn addition, IQVIA has analyzed its responsible cancer clinical trials (n200) to assess the main risk factors affecting clinical trialssurvey analysis shows that the COVID-19 outbreak does have a significant impact on patient recruitment in cancer clinical trials that are still ongoing, especially in the United States and Europe, where only 20% and 14% of research institutions are able to recruit patients at the normal rateTwenty percent of agencies in the U.Sand Asia no longer recruit patientsNote: The above survey results are based on feedback from 22 study principals, including 10 in the United States, 7 in Europe and 4 in Asiatrials with lower-than-normal recruitment efficiency for those patients, with one of the most influenin factors for the researchers' feedback being patient care, and other factors including the type of medication/pathway to administration, indications, patient physical status, etcIn addition, researchers are concerned about patient safety and a lack of researchers and resourcesRespondents alike said that regardless of the complexity of the trial design, a risk-benefit analysis of patients undergoing clinical trials was the most basic considerationNote: Each of the 13 study leaders listed three key factors that affect the recruitment of patients in ongoing clinical trials
    the researchers' feedback was similar to the same, and patient care, type of cancer therapy/pathway sourcing remained the focus of research institutionsAfter further interviews, most researchers said they would focus on evaluating research that requires intravenous administration, with oral therapy because patients can take their own medicine at home, and researchers are less concerned about such studiesNote: A total of 22 study leaders fed 52 key considerations for starting new cancer clinical trials
    as COVID-19-related diseases consume significant medical resources, and the authors investigated how researchers addressed barriers to clinical trial regulation and actual operationNearly 60 percent of the researchers believe that COVID-19 has a moderate to severe effect (delayed or canceled) on patient follow-upApproximately 80 per cent of the feedback suggested that a deviation from the actual practice and the test methodology would lead regulators to question incomplete follow-up dataMany researchers communicate with institutional review committees or ethics committees The Committee's main concerns are the safety of medical personnel, programme violations/deviations, and drug administration Note: 22 study leaders reported feedback on the impact of COVID-19 on patient follow-up, 11 researchers reported a total of 30 concerns about IRB/IEC
    When asked how to respond to challenges and ensure patient safety, the main researchers said they have used or considered the use of new technologies to reduce offline surveillance and patient visits to minimize the risk of virus exposure and spread, such as telemedicine, remote electronic medical records, etc Other coping strategies include mailing oral medications directly to patients and avoiding immunosuppressants Note: A total of 22 study leaders responded to 198 clinical trial assessment and monitoring strategies under the COVID-19 outbreak
    IQVIA's assessment of more than 200 cancer clinical trials for which it is responsible found that milestone node delays are the greatest risk to clinical trials from the outbreak, which can be caused by multiple factors, including center activation, patient recruitment, patient follow-up, data collection and cleaning, and so on Analysis of registration data showed that more than 200 interventional clinical trials were suspended between March and April in general, despite some limitations in the sample size, the findings of Professor Vanessa M Hubbard's team show edified that the COVID-19 outbreak had a significant impact on the development of cancer clinical trials Geographically, recruitment of cancer test patients in Asia between March and April was less affected than in Europe and the United States, which may be related to a decline in the number of newly confirmed COVID-19 cases in The Region during this period The four heads of clinical research from China, one from Wuhan, interviewed by the authors, said the clinical research infrastructure had returned to pre-outbreak levels or would be fully operational by the end of April by contrast, the u.S clinical research leaders interviewed said it would take three to six months for clinical trials to fully return to normal operation Some European clinical research leaders are reluctant to predict the timing of a return to normal clinical trials, as some countries still observe an increase in the number of confirmed cases of COVID-19 In addition, in view of the lack of comprehensive screening and the likelihood of asymptomatic cases spreading, the researchers expressed concern about the second wave of COVID-19 epidemic sepsis based on previous experience with influenza viruses Professor Vanessa M Hubbard's findings are consistent with a recent survey by the American Society of Clinical Oncology (ASCO) of US clinical researchers and the claims of other trial sponsors that suggest the risk of data loss or data collection delays in ongoing clinical trials, the risk of patient recruitment difficulties at starting new clinical trials, and the value of telemedicine for the smooth functioning of the healthcare system References: Samik Upadhaya, Jia Xin Yu, Cristina Oliva, et al Impact of COVID-19 on-oncology clinical trials Doi: 10.1038/d41573-020-00093-1 (original title: COVID-19 Affects Global Oncology Clinical Trials)
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