Common Sense Oncology Outlines 9 Core Trial Principles

The global Common Sense Oncology initiative, launched in 2023, aims to transform the cancer research and care landscape to put patient interests and outcomes first. The main idea: Cancer experts need to prioritize treatments that provide meaningful benefits to patients, namely those that improve overall survival and quality of life.

“One concern is that over the last 10 years or so, most of our new treatments have had very, very small benefits and we think the bar has dropped too low,” founding member Christopher Booth, MD, of Queen’s University in Kingston, Ontario, Canada, told Medscape Medical News in July 2023 when Common Sense Oncology was launched.

In the group’s first major publication since, Booth and colleagues laid out nine principles for improving cancer treatment trial design, analysis, and reporting. The article, published online in The Lancet Oncology on February 3 — on the eve of World Cancer Day — includes detailed checklists to assist investigators in adhering to these core practices.

“We’ve been working a long time to develop a helpful document for the design and reporting of clinical trials and if this is implemented, most of the problems in cancer drug development that we have been highlighting for years will be addressed,” first author Bishal Gyawali, MD, PhD, founding Common Sense Oncology member, told Medscape Medical News. “Then we can get back to focusing on optimizing access to treatment and we won’t have to keep fighting about the trial designs because trials will be conducted and reported properly.”

The principles, developed by expert consensus after a review of clinical trial evidence, existing guidelines for trial design, and the authors’ experience, address a range of factors to improve the design of clinical trials.

Principle 1 focuses on the control group treatment, calling on investigators to use “the best current standard of care” in the control group. Principle 2 notes that the preferred trial endpoint is overall survival or a validated surrogate. Principle 3 focuses on the need to measure absolute benefit, which might mean measuring the difference between groups in median overall survival times or the proportion of surviving patients at a prespecified time.

Gyawali and colleagues also address the importance of secondary endpoints — particularly health-related quality of life — which, according to Principle 4, should at least be a secondary endpoint, if not a primary endpoint, in cancer trials.

Accurately assessing treatment toxicities is important as well. Principle 5 notes that trial authors should report treatment toxicities objectively. The use of subjective language, such as “manageable toxicities” or “well-tolerated,” diminishes the importance of toxicity.

In Principle 6, the authors ask that trials be designed to show, or rule out, clinically meaningful differences in outcomes, not just show statistically significant differences.

The last three principles round out the group’s priorities. Principle 7 calls for better assessments of why patients are lost to follow-up, noting that censoring should be detailed, and sensitivity analyses should be performed to determine potential effects of censoring. Principle 8 notes that experimental treatments known to improve overall survival at later disease stages should be offered and funded for control group patients whose disease progresses. And Principle 9 says that trial reports should always include a plain-language summary.

Overall, these nine principles aim to ensure that any new therapies meet two basic goals: “Allowing patients to live longer or to live better, or both,” the authors wrote.

Publication of the trial principles and checklist mark “a huge milestone,” for Common Sense Oncology, said Gyawali, also of Queen’s University, Kingston, Ontario, Canada. These principles can help trial investigators move away from designing trials that focus on detecting small differences between treatments that may not be clinically relevant and move toward focusing on improving overall survival and quality of life.

Response to the Common Sense Oncology mission has been overwhelmingly positive, so much so, that it has been a challenge to incorporate individuals and groups interested in being part of the mission, Gyawali said.

“We are formulating a plan to get everyone involved,” he said. “I’m very optimistic — it will be a long journey, but I think we will be able to make at least some positive difference.”

Gyawali reported receiving consulting fees from Vivio Health. Booth reported having no disclosures.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on Twitter:@SW_MedReporter.