Writing in an accompanying editorial in the Journal of Clinical Oncology, David M. Dilts, PhD, MBA, CPA, CMA, acknowledged that “amazing progress” has occurred in some cancer types over the past four decades, “however, the process is still taking too many resources for too little gain.”3 Dr. Dilts, of the Oregon Health & Science University, Knight Cancer Institute, Portland, OR, likened this point in the history of cancer clinical trials to that of other meaningful—and radical—innovations in that what is required is vision and risk.

“There is a need to prioritize trials that are more clinically meaningful, even if they come with higher risks, because that is how one creates the future,” he added. “It is time that oncology clinical trials become less incremental and more innovative, striving for more, faster. Basically, it is time for them to invent the future of oncology care.”


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Conducting clinical trials is not without challenges. In the United States, only about 3% of patients with cancer participate in a clinical trial.2 The Pancreatic Cancer Survey: Learning Through Experiences, the first national survey of nearly 400 people living with pancreatic cancer or their caregivers, found that 49.1% never discussed the possibility of participating in a clinical trial with their physicians at the time of diagnosis. Only 4% discussed possible participation when the first treatment did not work, and only an additional 4% said participation was discussed after second or later treatments did not work. A total of 11.6% of survey respondents had participated in a pancreatic clinical cancer trial. The survey was conducted by the Pancreatic Cancer Action Network in partnership with Celgene.

Although patients are needed for clinical trials, Benjamin Kasenda, MD, of University Hospital Basel, Switzerland, and colleagues, in investigating the prevalence, characteristics, and publication history of discontinued randomized trials in Switzerland, Germany, and Canada, between 2000 and 2003, found that poor recruitment was the most frequently reported reason for discontinuation. Of the 24.9% of 1,017 initiated trials that were discontinued, 9.9% were due to poor recruitment. Of the trials, 28% involving patients were discontinued, compared with 3% for those involving healthy volunteers.4

Additionally, due to “the fragmentation of particular cancers to molecular subtypes and the challenges in accruing sufficient numbers of patients who have these cancers, the need for international collaboration in cancer clinical research has grown,” Bostjan Seruga, MD, PhD, of the Institute of Oncology Ljubljana, Slovenia, and colleagues wrote in The Oncologist.2 “International collaboration enables faster enrollment of patients, and results of such international clinical trials are more generalizable.”

The investigators, members of ASCO’s International Affairs Committee, explored the characteristics of—and barriers to—global cancer research via a web-based survey. Of the 300 selected oncologists with research experience from 25 countries invited to participate, 80 responded, 41 from high-income countries and 39 from low- and middle-income countries. Most were medical oncologists (62%) at academic hospitals (90%). Compared with respondents from low- and middle-income countries, they found that researchers from high-income countries “were more involved with academic and industry-driven research.”

Overall, the most important barriers to academic cancer research were found to be “lack of time and competing priorities, and regulatory procedures.” They concluded that additional investigation into these barriers is warranted.

References

  1. Ellis LM, Bernstein DS, Voest EE, et al. American society of clinical oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. 2014;32(12):1277-1280.
  2. Seruga B, Sadikov A, Cazap EL, et al. Barrier and challenges to global clinical cancer research. The Oncologist. 2014;19(1):61-67.
  3. Dilts DM. Time has come to raise the bar in oncology clinical trials. J Clin Oncol. 2014;32(12):1186-11874.
  4. Kasenda B, von Elm E, You J, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA. 2014:311(10):1045-1051.