A paradigm shift is taking place in the oncology clinical trial space, partially as a result of the Obama Administration launching its “Precision Medicine Initiative” earlier this year. Precision medicine is an innovative approach that takes into account individual differences in people’s genes, environments, and lifestyles.
According to a White House release, a $215 million investment in the President’s 2016 Budget will be allocated to the Precision Medicine Initiative to pioneer this research and provide clinicians with new tools, knowledge and therapies to select the treatments that work best for their patients. The funding will be spread out between the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Office of the National Coordinator for Health Information Technology (ONC).
The objective for the National Cancer Institute is to accelerate the design and testing of tailored treatments for cancer by expanding genetically based clinical cancer trials. In June of this year, the NCI announced the launch of its nationwide clinical trial, utilizing DNA sequencing. In other words, subjects are grouped based on similarity in their genetic mutations, not the location of their cancer. The grouping is also known as “basket trials”. In the study, a few thousand patients at 2,400 sites throughout the United States will be sorted out into over a dozen treatments based on their tumor’s mutation.
The American Society of Clinical Oncology also recently announced the launch of a project that will provide patients with drugs targeting similar molecular abnormalities, and collect the data from their oncologists in order to monitor the effectiveness of the treatments.
The National Institutes of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of over a million Americans who volunteer to participate in research. The trial subjects will be involved in the design of the Initiative and will have the opportunity to contribute various data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.
The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its privacy protection framework. As part of this effort, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome.