Maurie Markman, MD

The evaluation of diagnostic quality in precision medicine should almost certainly be assessed by standards different from those used in drug development.

As the great baseball catcher and philosopher Yogi Berra noted, “When you come to a fork in the road, take it.” And in my opinion, we surely are at that juncture with human papillomavirus vaccination.

Phase 3 randomized trials often fail to reasonably represent the actual population of patients seen in routine community practice.

Successful manipulation of the immune system to achieve regression of cancer, long an unfulfilled goal of oncologic investigation, is an ever-increasing reality in multiple clinical settings.

Despite the favorable comments and interest in clinical trials, the objective fact is that a distressingly low percentage of patients with cancer, in the range of 2% to 4%, are enrolled in clinical investigative efforts.

Accelerated regulatory approvals in the past 10 to 15 years, both of novel drugs and their use as part of newer strategies present a challenge to relatively simple drug development and clinical use paradigms.

because of the differences between the characteristics of research subjects and individuals routinely cared for outside the confines of a clinical trial, appropriately designed examinations of “real-world” populations may provide a more relevant picture of the actual influence of a particular therapeutic intervention.

Overall survival is a critically relevant end point in randomized oncology clinical trials, but its interpretation is often not as straightforward as some may wish to acknowledge.

Several articles in a recent issue of the high-impact journal Science highlight areas of concern in the scientific community that may have detrimental effects on communications regarding the human papillomavirus vaccination as a cancer prevention strategy.

A core component of any type of therapeutic research is to enhance clinical benefit.

What is noteworthy is the process whereby this patient employs both objective data and his personal beliefs to declare what he values.

Outcomes from randomized phase 3 cancer trials are the foundation for regulatory approvals of novel antineoplastic therapeutics and, when available, treatment guidelines.

Maurie Markman, MD, elaborates on the need to take a closer look at the benchmarks used in clinical trial designs in oncology.

The publication of the objectively meaningful outcomes in high-impact peer-reviewed medical journals does not necessarily result in the observations being implemented into routine clinical care.

Maurie Markman, MD, discusses maintenance therapy and how it differs from other strategies in cancer care.

In 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.

Peer-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.

From evaluating clinical outcomes to determining payment for services, measurements are important in health care.

Maurie Markman, MD, offers expert insights on the hurdles facing community oncologists, the uptake of biomarkers in the clinic, and an overview of what to look forward to in his area of expertise: gynecologic oncology.

There 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.

Despite 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.

Maurie Markman, MD, discusses the need for oncologists to improve communication with the public and patients.

Pragmatic clinical trials “inform a clinical or policy decision by providing evidence for adoption of the intervention into real-world clinical practice.”

Maurie Markman, MD, discusses the obstacles between implementing clinical trial data into practice.

Maurie Markman, MD, discusses the expansion and overlap of the language of science within different medical disciplines and the general public.

Maurie Markman, MD, discusses the obstacles presented to cancer efforts as a result of challenges to scientific authority during the COVID-19 pandemic.

Maurie 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.

Maurie Markman, MD, discusses the debate between surrogate end points of overall survival and progression-free survival in clinical trials within oncology.

It is difficult to know where exactly to begin this commentary regarding the FDA approval to permit commer-cial sales of the Alzheimer disease drug aducanumab-avwa.

Maurie 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.