A Revolution Is Pending for Real-World Data Use in Cancer Care
August 1st 2022In the opinion of this commentator, one of the more exciting developments in clinical investigation over the past several years is the increasing recognition of the importance of real-world data and its role for physicians, regulators, policy makers, patients, and society.
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Is It Time to Formally Recognize That PFS Is More Than a "Surrogate" End Point?
July 18th 2022Peer-reviewed articles continue to challenge the recognition of progression-free survival as an acceptable primary end point in randomized cancer trials or insist on labeling this objectively measured outcome as nothing more than a potential surrogate for effects representing actual clinically meaningful results.
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Peer-Reviewed Data Present an Essential But Problematic Component of Oncology Research
May 31st 2022There are serious concerns about textbook descriptions of peer review, specifically within the realm of clinical research, which pose a threat to both the objectivity of the field of investigative medicine and, perhaps most importantly, to the public’s support of clinical science.
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The Saga of Regional Therapy in the Treatment of Ovarian Cancer
May 17th 2022Despite numerous well-designed and conducted randomized trials, a definitive answer to the role of specific disease management remains unclear, particularly in the discussions of the optimal role for the regional delivery of cytotoxic chemotherapy in the treatment of patients with ovarian cancer.
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Serious Concerns Cloud Potential Benefit of Liquid Biopsy in Cancer Screening
February 3rd 2022Maurie Markman, MD, explains the concerns surrounding liquid biopsies in cancer screening, and why regulatory agencies should be cautious and not approve any proposed molecularly based cancer diagnostic screening strategy until the tool is shown to effect cancer-specific survival compared with a control population not undergoing such testing.
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The Future of Cancer Care Depends on Trust in the Scientific Community
January 4th 2022Maurie Markman, MD, shares how evidence strongly supports that approaches to cancer prevention have little chance of success unless those being targeted are willing to listen to, and ultimately trust, the recommendations being made by members of the scientific community.
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It Is Time to Reexamine Control Arms in Phase 3 Trials
December 23rd 2021Maurie Markman, MD on strategies to appropriately evaluate small but clinically relevant patient subsets for whom traditional phase 3 randomized clinical trials are difficult, if not impossible, to complete in a realistically timely manner.
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Oncology Drug Regulation Faces an Uncertain Future
December 1st 2021Maurie Markman, MD, discusses how agency leaders should be encouraged to improve regulatory science, include a patient’s perspective in approval decisions, reduce unnecessary bureaucracy and costs associated with the conduct of trials, and accelerate the overall review process for drug approval.
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Beyond the Peer-Review Publication: Addressing Implications of Research for Patients
November 4th 2021Maurie Markman, MD, discusses the need for peer-reviewed publications to encourage further discussion and debate, challenge existing ideas or dogma, or provide support for current biological concepts or in the clinical realm for treatment of patients.
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Challenges to Scientific Expertise: Future Implications for Oncology
October 12th 2021The continued uncertainties of the current and future status of the COVID-19 pandemic have resulted in a lack of trust in the authority of the scientific establishment in the United States, and elsewhere, as it operates during these difficult times.
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Untangling Fact From Bias in the Age of Social Media and Mistrust
September 2nd 2021It is difficult to overstate the confusion associated with our nation’s messaging regarding a well-considered, rational, and scientifically based public health–focused approach to the current and future ramifications of the COVID-19 pandemic.
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Misinformation on Cancer Prevention Stems from COVID-19 Communication Efforts
August 15th 2021One year ago, few objective observers would have suggested that the percentage of individuals who are currently fully vaccinated is less than 30%, despite the well-documented real-world success data for the vaccines in preventing serious illness, hospitalizations, and death from COVID-19 infection.
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Gaps Persist in Understanding the Fundamentals of Informed Consent
July 14th 2021Within the hierarchy of clinical trials, phase 3 randomized studies remain the gold standard, though some argue that appropriately designed meta-analysis of multiple studies provides even more definitive and meaningful insight.
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