Maurie Markman, MD

Several developments emphasize the increasing clinical relevance of germline testing within the oncology arena and the need for associated genetic counseling.

The coronavirus disease 2019 pandemic has raised the public profile of experts in infectious disease, epidemiology, and public health.

These are disquieting times for clear and decisive messaging regarding vaccines.

Precision medicine should be seen as being synergistic―or at a minimum additive―to population medicine.

The explosion of COVID-19 studies illustrates questions that have plagued oncology research.

At this moment, we should consider what it will take for the scientific community as a collective entity to self-regulate far more forcefully so that the actions of a limited number of its members do not squander the well-deserved awakening of public trust in the entire scientific enterprise.

From the earliest moments of medical school instruction, through residency and fellowship training, physicians are taught the primacy of the randomized phase 3 trial in the hierarchy of evidence-based medicine.

From the earliest moments of medical school instruction, through residency and fellowship training, physicians are taught the primacy of the randomized phase 3 trial in the hierarchy of evidence-based medicine.

What was simply unimaginable just a few weeks earlier regarding the potential impact of an infectious illness in the United States on jobs, schools, the economy, and personal and family safety has become a stream of daily pronouncements about the severity of the pandemic and how best to respond.

The conduct of randomized trials in surgical oncology, although highly appealing in concept, may be problematic, especially in complex settings where the skills, experience, and clinical judgment of individual surgeons and their institutions may vary greatly.

This has been a difficult time for public health policy and regulatory organizations struggling to deal with rapidly changing and unquestionably serious societal health-related issues and concerns. The list of problems these agencies must tackle is growing, and so are the questions about the strategies that should be used to address these threats.

Segments of the population have apparently rejected the well-documented clinical utility of vaccination for protecting individual and public health. An immediate specific concern is the contentious matter of measles vaccination, which has been well-reported in the lay press.

Clinical trials in oncology serve several purposes; these efforts ultimately help define and, potentially, modify the "standard of care" in routine cancer management.

The cancer treatment community's ultimate perception of a successfully completed phase III randomized trial depends in large part on how well the trial was conceived and structured. To permit adequate accrual in a timely manner and optimize the chances for a study to achieve success, the question it poses must be relevant to ensure interest by clinical investigators, referring clinicians, and potential research subjects. Further, the initiative must have adequate funding for data collection and analysis, translational laboratory investigations, and other trial components.

A better understanding of how unique germline variants affect the metabolism or elimination of individual agents or drug classes could lead to a truly revolutionary change in the way cancer is treated.

Even the most basic investigation into fundamental mechanisms of the development and progression of cancer in an in vitro system may generate data that, ultimately, prove vital to developing new approaches to prevent, diagnose, and treat malignant disease.

Placing the results of a single trial in the context of real-world, everyday practice is increasingly difficult because of the number of available options and the absence of studies that directly compare individual strategies.

Although hereditary cancer risk was defined solely by family history in the not-so-distant past, today increasingly robust data may help define an individual’s heightened lifetime risk based on the presence of specific molecular findings within the germline

When discussing the topic of vaccination to prevent serious childhood illness, an increasing number of individuals refuse to accept the unequivocally demonstrated value of this public health strategy despite the very low risk of harm.

The often intense and frequently highly focused effort to seek scientific purity in answering questions within cancer clinical trials raises serious concerns regarding the ethical foundation of certain studies.

Certain themes and questions about individualized, scientifically unanswerable dilemmas often recur when talking with patients and families about treatment.

Even if a disease is diagnosed as “incurable,” or progression to a state of incurability subsequently develops, the time between diagnosis and death is being prolonged and the quality of life improved with novel oncologic interventions, such that continued therapeutic efforts are justified.

There is no more important principle in the conduct of legitimate therapeutic investigation than ensuring the adequacy of informed consent of the prospective clinical trial participant.

With the revolution in our understanding of cancer’s basic molecular biology, it is increasingly evident that subgroups of cancer originating from specific regions of the body have unique natural histories and respond to very different therapeutics. For example, the importance of BRCA mutations, which define a subset of ovarian cancers impressively sensitive to PARP inhibitors, has striking altered the management of this group of gynecologic malignancies.

The cost of antineoplastic therapy and essential supportive care medications have a substantial negative impact on patients with cancer and their families.

Particularly in the oncology arena, there are several serious scientific, ethical, and pragmatic concerns associated with ongoing reliance on placebo-controlled studies.

Although concerns have been raised in recent years regarding the need for randomized trials to augment the body of clinical understanding, one critical issue that has failed to generate sufficient discussion is how the choice of the control arm affects the interpretation of an individual study’s outcome and potentially undermines the ethical basis for that particular study.

For clinical science, particularly oncology, there has never been a more exciting era than today.

Today, with the routine performance of single gene or germline panel testing, as well as a critical focus on prospective follow-up of individuals with incompletely understood germline variants, clinicians are developing an increasingly robust appreciation for the influence of an individual’s genetic background on the likelihood of developing specific malignancies or a group of malignant conditions.

It may be difficult for many who have not lived through an outbreak to appreciate how critical it is to never permit the disease to reappear.