Real World Evidence Evidence & Data Partnerships

Oct 14, 2014 - Oct 15, 2014, Bethesda

This year real patient data will change healthcare.

10 Clinical Trials in Three Years, Yet Lung Cancer Accounts for 15% of all New Diagnoses

An analysis of oncology clinical research data uncovers the worrying disparity between incidence and mortality of cancer, and the volume of research conducted in these key areas.



Researchers at Duke University published this analysis, which is part of the Clinical Trials Transformation Initiative, in the JAMA journal of Internal Medicine. Their findings uncovered a worrying gulf between the prevalence of a particular cancer and the amount of research dedicated to it. Among other findings, researchers discovered that although lung cancer has the highest level of incidence (14.5% of all new diagnoses), only 9.2 clinical studies in the register have focused on it. Similarly, lymphoma represents 4.8% of cancer cases and so only 6.6% of studies within the register have conducted research on it.

The data was taken from nearly 9000 oncology clinical research records registered with the  ClinicalTrials.gov website between 2007 and 2010.

As well as a lack of research in key areas, researchers also uncovered a shocking lack of depth to the research being carried out.

It was discovered that in the early phase of the study, cancer-related trials would evaluate one form of treatment without comparing it to any other therapies. Following this, the larger, robust trials assigned individuals to diverse treatments on a random basis, which prevented doctors and patients from determining who received the investigational therapy so as to eradicate the occurrence of bias.

Traditionally, clinical cancer studies have been smaller and less vigorous as researchers want to get treatments for life-threatening diseases out to patients at a quicker rate. This preference for a less vigorous clinical trial design for cancer related trials is varies considerably from other areas of medicine.

It was also revealed that drugs which are labelled as ‘one use’ in some instances and then ‘off label’ in others do not have strong requirements for additional regulatory approvals. 

Assistant professor of medicine and lead author of this study Bradford Hirsch highlights the value of this study as he says, “We need to understand the strengths and weaknesses of the clinical studies in oncology. There are a lot of reasons for why cancer studies are different than those for other illnesses – cancer is a very grave disease and for a long time there weren't a lot of treatment options. But what we're trying to understand is if those differences justify differences in the clinical research being conducted.”   

Chair of the board of directors for Fight Colorectal Cancer Nancy Roach highlights that this study is important for the future of healthcare as, “People who enroll in clinical trials expect their participation to lead to future benefits for patients. Small, single-institution trials are not likely to change the standard of care. I see this paper as a call to action to encourage academic institutions to collaborate with each other on more robust trials that may ultimately lead to clinical benefit.”



Real World Evidence Evidence & Data Partnerships

Oct 14, 2014 - Oct 15, 2014, Bethesda

This year real patient data will change healthcare.