Maurie Markman, MD

Articles

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.

Is Therapeutic Value a New Name for Medical Paternalism?

October 14th 2022

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

Interventions Are Needed to Bridge Gaps Between Real-World and Clinical Trial Populations

September 29th 2022

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

Benchmarks in Clinical Trial Design Require Closer Examination by Oncologists

September 14th 2022

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

Implementation Research Takes On an Increasingly Essential Role in Oncology

August 29th 2022

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.

Unique Aspects of Maintenance Therapy in Oncology Require Careful Consideration

August 14th 2022

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

A Revolution Is Pending for Real-World Data Use in Cancer Care

August 1st 2022

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.

Is It Time to Formally Recognize That PFS Is More Than a "Surrogate" End Point?

July 18th 2022

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.

Metrics in Clinical Medicine and Clinical Trials Should Look Beyond the P Value

June 30th 2022

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