How Can Clinical Trials Be Improved?

By Michelle Churchman, PhD

Clinical trials have long served an essential role in advancing the prevention, diagnosis, and treatment of many types of cancer. Made possible through a rapidly growing base of individual genomic data, many of today’s novel insights are facilitating research breakthroughs that are paving the way toward more personalized cancer care and, in turn, better patient outcomes. However, despite the noteworthy progress researchers have made to date, significant challenges remain, and there are still critical gaps in the cancer knowledge base. To fill those gaps, clinical trials must be improved, mainly by eliminating synergy-draining research silos that inhibit collaboration.

Strong alliances in oncology research are necessary because many of today’s most pressing matters are best confronted through a cross-functional team approach. For instance, in many cancers associated with specific genetic mutations, the clinical relevance of those mutations is still not well understood within the general medical community. In-depth functional genomic analyses performed by multidisciplinary teams are needed to determine whether certain gene mutations are cancer drivers or simply innocuous passengers along for the ride as cancer develops.

Furthermore, no malignant tumor is merely a mass of homogenous cancer cells; instead, each tumor consists of a heterogeneous mixture of diverse genetic defects, gene expression patterns, epigenetic markers, metabolic changes, and differentiation states. What’s more, tumor cells are not static; cancer continually evolves in response to changing conditions over time. Indeed, a major challenge faced by researchers in modeling the diverse biology of cancer is to create practical and reproducible systems that can accurately replicate its many nuances as well as the numerous variables among patients with the same type of tumor.

As such, to safely bring greater benefits to more patients more quickly—the overriding objective of clinical trials—improvements are needed to enhance exploration and refinement of several key elements, such as tumor profiling techniques, timing and selection of samples, and the effects of tumor heterogeneity. Through a cohesive collaborative effort, those improvements can be realized.

Research Silos Hinder Progress

Many of today’s top academic cancer centers are set up in departmental silos, often with inpatient care provided in a hospital, outpatient care provided in another location, and research performed in an isolated laboratory or separate building. Of course, in some ways, those silos can be effective. Science is a creative domain, and individual freedom is important. Plus, a critical mass of like-minded scientists with deep, disciplinary-specific knowledge is essential for tackling certain complex problems head-on. With that said, research silos are not without drawbacks.

Excessive compartmentalization can have negative effects, such as fragmented thinking, disorganization, duplication of effort, poor communication, and missed opportunities. And while a silo mentality can be a troublesome issue in any endeavor, it is especially problematic in clinical trials, the success of which directly depends on the collective efforts of multidisciplinary teams of experts. When major players work in isolation, valuable synergy is lost.

The key to improving clinical trials—and thereby expediting the discovery and development of novel cancer therapies—is creating a more unified approach to patient care and research that motivates a higher level of collaboration between clinicians and scientists. This will require many researchers to shift away from working independently within silos full of information that has unmet potential and move towards working as a member of a team with integrated systems that provide actionable knowledge to advance cancer care from bench to bedside. With the latter type of infrastructure in place, clinical and scientific discoveries can be realized more rapidly. To get there, however, it will first be necessary to change many attitudes, behaviors, and cultures surrounding shared data. As a respected pioneer of oncology-focused bioinformatics, M2GEN is partnering with leading cancer centers and biopharmaceutical companies around the U.S. to make that happen.

Breaking Down Barriers to Clinical & Scientific Collaboration

M2GEN is bridging the gap between discovery and patient care by eliminating restrictive research silos and removing other roadblocks to progress. In establishing a system of trusted partnerships among the key stakeholders in cancer research, our overall goal is to foster alliances that spark innovations in cancer prevention, diagnosis, treatment, and support. We encourage independent scientists to look out from their highly specialized research platforms and connect with other deep thinkers across the intellectual landscape. We recognize the vast potential and vital role of clinical and scientific cooperation, and we are dedicated to cultivating and supporting it.

M2GEN is ushering in the next generation of precision cancer medicine by leveraging shared clinical and molecular data through our state-of-the-art bioinformatics solutions, such as the first-in-kind Oncology Research Information Exchange Network^® (ORIEN^®) AVATAR Program. This robust data solution brings together scientists, clinicians, and patients with a goal to profoundly expand how various cancers are studied and treated. A richly integrated data warehouse, AVATAR compiles and links longitudinal clinical data and molecular data that is voluntarily provided by patients with various types of tumors. AVATAR subscribers have unique opportunities to observe and learn from the experiences of thousands of patients who have consented to be studied over their lifetime and recontacted if identified to be potentially eligible for suitable clinical trials as opportunities arise. Additionally, M2GEN inspires the exchange of ideas by providing an accessible forum for shared research initiatives among ORIEN member institutions, research interest groups (RIGs), and industry partners.

In all of those ways and more, M2GEN is essentially upending the traditional clinical trials structure. Not only are we facilitating therapeutic advances and better patient care, but we are also providing our research partners with a distinct competitive advantage over scientists working in disconnected silos.

It can be daunting to consider all that yet needs to be done to conquer the multifaceted disease known as “cancer,” a term that in reality encompasses hundreds of unique and complex conditions. Although that goal is undeniably challenging, remarkable progress has been made to date to suggest that it is indeed tenable. Through streamlined communication, effective collaboration, and shared resources, M2GEN is optimistic that we can collectively achieve great things. Cancer is a problem that must be solved by working together.