Maurie Markman, MD

Articles

Reality Takes a Back Seat to Rhetoric Used in Objective Assessments of Cancer Treatment

November 6th 2023

It is time for society to address the critical nature of our current unsustainable oncology pharmaceutical marketplace, and it is also essential that whatever solutions are proposed and implemented do not incorporate inappropriate labeling of outcomes that negate meaningful measures of clinical benefit.

The Bleak Fiscal Implications of Advanced Cancer as a Chronic Illness

October 13th 2023

Maurie Markman, MD, highlights the rather profound fiscal implications of the combined effect of 2 quite different but closely related components of the rapidly evolving cancer treatment paradigm.

Generic Drug Shortage of Platinum Agents in Ovarian Cancer Sends Cautionary Signal

September 6th 2023

The well-publicized severe shortage of vitally important generic antineoplastic agents has highlighted a serious misalignment in the existing market-based and regulatory environment that permitted such an extraordinary situation to develop without meaningful resolution.

Unresolved Issues in Antineoplastic Drug Therapy: Is It Finally Time to Address?

August 14th 2023

Several articles featured in a recent issue of the highly respected publication the Medical Letter on Drugs and Therapeutics highlight themes across drug development that are relevant within the broad antineoplastic arena. The topics range from appropriate control arms in randomized clinical trials to sponsorship of trials to the rationale for developing novel agents when suitable, cost-effective biosimilar and generic products are available.

Evaluating Toxicities of Antineoplastic Drug Therapeutics: Is It Time for a Critical Review?

July 24th 2023

An evaluation of the utility of a cancer therapeutic in a clinical trial is determined through metrics that define 2 distinctive features of an antineoplastic strategy: efficacy and toxicity. Although that may be an oversimplification, the aim of such therapy is to improve clinical outcomes.

Interpreting Clinical Trial Data Is Not as Simple as It May Seem

July 10th 2023

In our fast-moving world where a report of a clinically important trial finding may be simply a 60-second sound bite for both lay and medical communities, it is critical that great care must be taken that reported conclusions are understandable to all, not just the statisticians.

Rapid Accelerating Changes in Cancer Management Through the Lens of Ovarian Cancer

June 13th 2023

Maurie Markman, MD, discusses changes in cancer management as seen in ovarian cancer.

The Placebo: A Controversial Element of Randomized Cancer Clinical Trials

May 19th 2023

The potential effectiveness of employing placebo in cancer clinical investigation is not difficult to appreciate, but the use of this approach has been, and continues to be, controversial.

Oncologists Prepare to Bridge Knowledge Gap on Clinical Trial Outcomes With Patients

May 8th 2023

When patients with cancer are asked to be participants in a clinical trial, they are informed that a primary purpose of the investigative effort is to develop objectively valid, generalizable information that may be of value to patients with the same malignancy or benefit researchers in the development of future studies.

Nonclinical Societal Issues Create Problematic Intersection With Cancer Prevention

April 11th 2023

Recent events threaten to seriously diminish the well-established and generally positively viewed role of both scientific and clinical expertise in health-related public policy.

Precision Medicine Takes On an Increasingly Relevant but Misunderstood Role in Oncology

March 28th 2023

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

Diagnostic Cancer Trends Showcase Urgent Need to Increase HPV Vaccination

March 16th 2023

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.

Pragmatic Approaches to Cancer Management in the Absence of Randomized Trial Data

March 2nd 2023

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

The Implications of the Underappreciated, Evolving View of Cancer as a Chronic Illness

February 21st 2023

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.

Barriers to Confirmatory Trial Enrollment Present Unique Hurdles for Accelerated Approvals

February 8th 2023

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.

Exploring the Nuances of Regulatory Approval Vs Optimal Use of a New Antineoplastic Agent

January 31st 2023

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.

The Potential Clinical Utility of Cross-Trial Comparisons: An Example From Gynecologic Cancer Literature

January 12th 2023

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 Highly Relevant but Potentially Problematic End Point in Randomized Trials

December 21st 2022

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.

Effective Communication on HPV Vaccination Benefits Is Needed

November 29th 2022

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.

Defining Clinical Benefit in Oncology Trials Is Not as Simple as Some May Believe

November 14th 2022

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