THE cancer moonshot initiative
Led by Vice President Joe Biden, the initiative works toward making more therapies accessible to more patients and to improve the likelihood of detecting cancer in its early stages. Through the initiative, Biden also hopes to increase awareness of clinical trials.
Why is The initiative important?
The sharing of clinical data provides more comprehensive results on the benefits and risks that accompany a treatment. Sharing data from clinical trials can also improve the efficiency of clinical research and prevent unnecessary duplication of trials, including trials of products that other researchers have already found to be unsafe or ineffective. Through data sharing, scientists can test and build on the work of others in the field, propelling a collective effort toward the prevention, detection, and treatment of disease. Furthermore, healthcare professionals and patients can use the shared data to make more informed decisions about clinical care.
However, much of the data generated by clinical trials is not made public or shared beyond the primary data holder. Researchers may withhold information for "competitive reasons" because of the competition for publication in medical research. Due to this lack of transparancy, researchers have difficulty accessing information on the treatments that have been already and thus struggle in making real strides in the development. As a result, less than 5% of American cancer patients have chosen to participate in clinical trials.
However, much of the data generated by clinical trials is not made public or shared beyond the primary data holder. Researchers may withhold information for "competitive reasons" because of the competition for publication in medical research. Due to this lack of transparancy, researchers have difficulty accessing information on the treatments that have been already and thus struggle in making real strides in the development. As a result, less than 5% of American cancer patients have chosen to participate in clinical trials.
Other considerations
In 2015, The Institute of Medicine (IOM) published a report titled Sharing Clinical Trial Data – Maximizing Benefits, Minimizing Risk.
The report detailed the need to balance the interests of different stakeholders, which include healthcare professionals and clinical trial participants, with the public interest of having the most advanced, accurate information possible regarding the effectiveness and safety of treatments.
For the process of sharing clinical data, guiding principles and specific recommendations regarding what, when, and how data should be shared need to be established. To ensure that such sharing is responsible and sustinable, the laws and jurisdictions of regions where the trials will be conducted must also be considered.
How will it be implemented?
Back in 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) required clinical trial researchers to register and submit summary-level trial results information to ClinialTrials.gov for specified trials of FDA-approved drugs and devices. Through the FDAAA, which required the results to be submitted no later than one year after the clinical trial has been completed, public access to information about and evidence from applicable clinical trials increased.
The Cancer Moonshot Initiative expands on the FDAAA by promoting transparency across clinical trials, regardless if they are subject to the FDAAA. Biden has proposed a new website called Trials.Cancer.gov, which offers a searchable index of thousands of clinical trials. To help enforce the initiative, the U.S. Food and Drug Administration has been expanding the eligibility criteria for clinical trials. In a move he noted might cause controversy, Biden has also directed the U.S. Department of Health and Services to create penalties for researchers who do not share the information they have collected from clinical trials.
The Cancer Moonshot Initiative expands on the FDAAA by promoting transparency across clinical trials, regardless if they are subject to the FDAAA. Biden has proposed a new website called Trials.Cancer.gov, which offers a searchable index of thousands of clinical trials. To help enforce the initiative, the U.S. Food and Drug Administration has been expanding the eligibility criteria for clinical trials. In a move he noted might cause controversy, Biden has also directed the U.S. Department of Health and Services to create penalties for researchers who do not share the information they have collected from clinical trials.
"What happens next is a difference between life and death. If there's treatment there, then you know there's hope, but for some people, hope is a clinical trial." - JOE BIDEN