Earlier this month the Commission on Evidence-Based Policymaking publishoped a Request for Comment in the Federal Register. The request is general in focus, seeking to gather information on a variety of topics that the Commission is obligated to examine under its mandate. Submissions are due by November 14.
That mandate, and the Commission, was a creation of Congress. The fifteen-member commission has until September of 2017 to complete its work. It will prepare a report for the President and the Congress providing its recommendations after conducting
“[A] comprehensive study of the data inventory, data infrastructure, data-base security, and statistical protocols related to Federal policy-making and the agencies responsible for maintaining that data.”
The bill is resource focused. While there is a provision in the bill to include recommendations on particular evidence-based policymaking techniques such as randomized control trials, the focus in the bill is on optimizing existing data resources and making them more accessible for the purposes of program evaluation.
Back to the Request for Comment
. The questions are focused primarily on data, whether its data infrastructure and security or how survey and other statistical data can be integrated into program design, analysis and evaluation.
The Commission has met twice since its formation, with the first meeting
focused on overall goals and work plan, and the second meeting
focused on privacy. Regrettably the Commission website
appears to suffer from some link issues.
Since the Centers for Disease Control and Prevention (CDC) issued guidance for travel to the Wynwood in Miami affected by mosquito-borne Zika, a total of 43 such cases have been reported in South Florida (compared to more than 3300 travel-related cases of Zika reported across the United States since January 2015) as of this writing. There have been no other reported mosquito-borne cases in the 50 U.S. states, but there are over 19,000 mosquito-borne cases in U.S. territories (primarily Puerto Rico).
The latest news on the mosquito-borne virus spread in Florida is mixed. While the Wynwood neighborhood is no longer considered an area of active virus transmission (it was active from roughly June 15-September 18), Miami Beach is still active (and has been since about July 14). To be extra cautious, CDC is encouraging those who are pregnant or are partners of pregnant women to avoid unnecessary travel to Miami-Dade County. Those who may have been exposed to the virus should avoid sex for a minimum of 8 weeks to minimize the chances of either transmitting the disease or increasing the chances of birth defects for any pregnancy following exposure.
Meanwhile, Congress has done little more than posture over passing a funding package for combating the virus. With the fiscal year officially closing on Friday, any continuing resolution (CR) that is passed (the most likely way the government will stay funded on October 1) would need Zika funding added in order for it to be effective. I am not optimistic. The Department of Health and Human Services has done what it can to move money around within existing appropriations, but a CR without Zika language would not provide much relief, as the Department can likely do little more than continuing to cannibalize research on other diseases and viruses. Regrettably, it seems that with most affected Americans also lacking direct representation in Congress, that Zika will remain something that can be ignored and delayed due to lack of concentrated legislative effort.
On Friday the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) announced actions that should increase the availability of clinical trial data. This parallels an announcement from the Vice President focusing on clinical trials concerning cancer.
The overall goal of these policies is to make the clinical trial much more effective. The announcements focus on making it easier to use clinicaltrials.gov and similar online resources for accessing and sharing clinical trial data. Under the final rule issued by HHS, more trials involved with FDA-regulated drug, biological and device products will need to provide registration data and results on clinicaltrials.gov. This should also make it easier to find clinical trials that need participants. The rule takes effect on January 18, 2017, and affected parties must comply within 90 days of that date.
The NIH policy applies to all NIH-funded clinical trials, which means that some clinical trials not otherwise covered by the HHS rule will fall under the NIH policy (primarily early stage trials for FDA-regulated drugs, biologics and devices and small device feasibility trials). It also takes effect on January 18, 2017.
Complementing the expansion of registration requirements are new compliance measures. Both the HHS rule and the NIH policy allow for marking the clinical trial as non-compliant on ClincalTrials.gov and for withholding grant funds. The HHS rule allows for monetary penalties, and the NIH policy would allow for non-compliance to be considered in future grant applications.
Additionally, the NIH is working to improve the usability of ClincalTrials.gov and may be using the recently released redesign of trials.cancer.gov. While White House Innovation Fellows assisted with the trials.cancer.gov redesign, NIH intends to work with the 18F group at the General Services Administration to improve the clinical trials website.
The first Friday of every October is Manufacturing Day in the United States. The 2016 edition takes place on October 7. Co-produced by manufacturing organizations and the Commerce Department’s Manufacturing Extension Partnership, Manufacturing Day is intended to publicize manufacturing in the country and help people better understand the state of manufacturing in the country.
The Obama Administration is looking to publicize Manufacturing Day with stories and incentives to establish and/or strengthen connections between manufacturers, makers, and educators. They are looking for stories, but they have to be submitted by tomorrow, September 16. I suspect the input will help the Administration create the list of government and private sector commitments they like to announce with some of their big science and technology events. Think of it as a science and technology flavored use of the ‘bully pulpit’ of the Presidency.
If you’re interested in participating in Manufacturing Day activities (which are not limited to October 7), consult the event listings on the Manufacturing Day website.
On October 13, President Obama will travel to Pittsburgh for the White House Frontiers Conference. Co-hosted by the University of Pittsburgh and Carnegie Mellon University the event is intended to “explore the future of innovation here and around the world” and focus on building the nation’s capacity in science, technology and innovation.
Frontiers as defined by the conference are quite broad, broken out into personal, local, national, global and interplanetary frontiers. Some of the attendees will be taken from a list of those nominated by the public.
Given how close we are to the election and the transfer of power to a new administration, it’s unclear to me what initiatives, if any, we might expect from this event. Certainly there will be mention of the Administration’s innovation work to date, and there will likely be announcements of new innovation commitments by federal agencies and private organizations. Having another conversation about innovation has some value, certainly. But without linkage to future action, how valuable will the conversation be?
Today the Cancer Moonshot Blue Ribbon Panel submitted its report to the National Cancer Advisory Board (H/T The Guardian). Appointed in April, the panel was tasked with providing recommendations on how to best advance the broad goals of the Cancer Moonshot, which is focused on improving detection, treatment and prevention of cancer. Specifically, the Moonshot is focused on better using the existing resources of public and private entities involved in cancer research and treatment to make it accelerate advances against the various forms of the disease.
The panel divided the topic into seven broad topics, and there are recommendations in the report from each area. They are:
- Clinical Trials
- Enhanced Data Sharing
- Cancer Immunology
- Implementation Science
- Pediatric Cancer
- Precision Prevention and Early Detection
- Tumor Evolution and Progression
Where practical, some recommendations were merged into the final draft. A common theme in many of the recommendations was the sharing of information and the increasing of communication between parties that aren’t currently doing so. Another common theme was the development of promising research resources as well as specific therapies and/or technologies. The recommendations (consult the report for additional details) are:
- Network for Direct Patient Engagement
- Cancer Immnotherapy Clinical Trials Network
- Therapeutic Target Identification to Overcome Drug Resistance
- A National Cancer Data Ecosystem for Sharing and Analysis
- Fusion Oncoproteins in Childhood Cancers
- Symptom Management Research
- Prevention and Early Detection: Implementation of Evidence-Based Approaches
- Retrospective Analysis of Biospecimens from Patients Treated with Standard of Care
- Generation of Human Tumor Atlases
- Development of New Enabling Cancer Technologies
The panel also identified some policy issues that will pose challenges to implementing the recommendations. The issues aren’t part of their report, but they have been forwarded to the Vice President’s task force and other relevant entities. Those policy issues aren’t discussed in detail in the report (you can find some discussion of them in the recommendations), but are:
Coverage and reimbursement
Privacy and consent with regard to patient data
Fragmentation of the delivery of patient care in the community
The need to improve the clinical trials system
Incentives to encourage pediatric drug development
New federal research funding models
Barriers to data sharing
Critical to all of these issues and recommendations is funding for the Cancer Moonshot. But that may not come. As ScienceInsider reports, neither the House nor the Senate appropriations legislation contains anything resembling the $680 million requested by the Obama Administration to support the Moonshot. Depending on how this year’s kabuki theater/budget brinksmanship unfolds, there may be a new President by the time Congress has fully funded the government for the 2017 Fiscal Year (which starts this October 1).
While developed by cancer experts, the recommendations are presented in a way that should be accessible for all audiences, even the lay public that does not have direct or indirect (through family or friends) experience with the disease. I’d encourage other report-generating bodies to copy that style when practical for their own work.
The National Cancer Institute has more material on the report and the panel at its website
, including videos for each of the recommendations.
The next scheduled meeting of the President’s Council of Advisers on Science and Technology (PCAST) will be on September 30 from 8:30 to 12:30 p.m. Eastern in Washington. No official draft agenda has been released, but the Federal Register notice announcing the meeting offers some details. As usual, there will be a webcast and it will be archived shortly after the meeting. Online registration is open for those intending to attend in person.
PCAST also held a conference call this week, specifically to vote on pending reports on forensic science and biodefense. The forensic report has caused a stir, in part because a Wall Street Journal reporter has written an article (possibly behind a paywall, or at least made really hard to read) based on a review of a draft report. The article suggests that the PCAST report will come to conclusions comparable to those reached by a National Academies study back in 2009 that called into question the strength of the underlying research supporting many forensic science techniques. So the news is likely not that this is a new problem, but that it is still a challenge. The federal government has been working on building the research base, and continued concerns prompted PCAST to start its work on the report in late 2015.
But there are other items that PCAST will discuss on September 30th. Besides the forensic science report, the Council will consider reports on biodefense and water science and technology. Also scheduled for the meeting are sessions from experts on data and justice, as well as agriculture preparedness and soil sciences. Once details on exactly who these experts are is made available, I might be able to provide context for why PCAST is hearing from them.