Commission On Evidence-Based Policymaking Will Hold First Hearing This Week

On Friday, October 21, the Commission on Evidence-Based Policymaking will hold its first public hearing in Washington, D.C.  It is the first of three planned hearings across the country to hear from stakeholders about the Commission’s work.  The goal of the Commission is to develop a strategy for increasing the availability and use of data to develop evidence about government programs.

The commission is accepting requests for oral statements through today, and welcomes written statements from stakeholders as well.  There is also an open Request for Comment from the Commission that closes on November 14.  As of the end of Saturday, October 15 a whopping 8 comments have been submitted to that request (none have been posted as yet).

Friday’s hearing is the third public meeting of the Commission, which intends to hold two more meetings by the end of this year.  The two additional stakeholder hearings are planned for early in 2017.  One will take place in the western U.S. and the other in the center of the country.  The Commission has an expiration date of September 2017, so it is interested in working quickly.  If you have information that should come before the Commission, you should work quickly as well.

Congress Kicks Budget Can Down The Road, But Funds Zika Work

As is all too common, the Congress managed to avoid its responsibility to pass a budget prior to the start of the new fiscal year (which is October 1).  Earlier this week, after much wrangling, the House and Senate agreed on a continuing resolution to fund the government until December 9.

What a continuing resolution means is that unless otherwise provided for in the resolution, the government will be funded at the same levels as the previous fiscal year.  Any programs that would get different funding levels in the new year (or would were set to start or finish in the new year) are in bureaucratic limbo.  While this is a new normal in this century, these resolutions complicate government operation because they make it much harder for agencies to plan for and do their work.  There’s simply no confidence that there will be the money for intended programs.

The continuing resolution includes $1.1 billion for dealing with the Zika virus.  It’s slightly more than half what the Obama Administration requested back in February.  During the seven months in which there was no new funding, the National Institutes of Health and the Centers for Disease Control Prevention had to do their work by ‘borrowing’ from funding designated for fighting other diseases.  There is no provision in the continuing resolution to restore those funds.

One stumbling block (out of several) on the way to this continuing resolution involved funding for addressing the water problems in Flint, Michigan.  While not included in this legislation, a deal is in place to address water infrastructure in separate legislation.  We’ll see if it actually ahppens.

House Member Introduces Bill To Report Sexual Harassment To Research Funders

Representative Jackie Speier recently introduced legislation that would connect incidents of sexual harassment by university researchers to their federal research grant funds.  Called the Federal Funding Accountability for Sexual Harassers Act, the bill was prompted in part by research indicating sexual harassment is a serious problem for researchers as well as a spate of high profile academics’ harassment coming to light.

The bill would require universities to report instances of of harassment cases involving principal investigators (including co-principal investigators and similarly senior staff) to all federal research funding agencies that have awarded funds to that university for the 10 years prior to the finding of harassment.  Universities would also be required to report complaints of harassment that have not yet been fully investigated within 6 months of the date of complaint.  Funding agencies will be required to consider these reports when making funding decisions, and note cases where a funding decision was granted to an individual who is the subject of such a complaint.

With just a few short weeks left in the Congressional calendar, this bill is not likely to pass this year.  Assuming Representative Speier is re-elected (incumbents usually are), I would expect to see the bill return in the new Congress.  In the meantime, at least two funding agencies, the National Science Foundation (NSF) and NASA, have expressed their interest in rooting out such bad activity, reminding grantees that the agencies are obligated to comply with civil rights laws, including Title IX which addresses sexual discrimination in education.  The NSF has noted a willingness to withhold grant money for non-compliance with Title IX, but has yet to do that.  This legislation might make it easier for NSF and other agencies to enforce the law, but I would hope that there are other tools that can help fight this problem.

White House Festival Sprinkles In Some Science And Tech

The Obama Administration will host a South by South Lawn festival at the White House on Monday, October 3.  Meant to evoke the South by Southwest festival (which the President attended this year), South by South Lawn will include the winners of the latest White House Film Festival, musical performances, art displays and other interactive exhibits.

But from the marquee discussion with Leonardo DiCaprio throughout the festival, science and technology are part of the event.  DiCaprio will speak with the President and climate scientist Dr. Katharine Hayhoe before the domestic premiere of Before the Flood, a climate change documentary produced by DiCaprio (among others), who also appears in the film.

Aside from the conversation and film premiere, there are several sessions in the afternoon that at least brush up against innovation, science and/or technology.  Along with the interactive exhibits, attendees can learn more about the Cancer Moonshot, design for everyone, addressing food (in)security and using technology and innovation to address societal problems.

The event will be streamed through Facebook and the websites of the White House and South by Southwest.

Evidence-Based Policymaking Commission Seeks Input

Earlier this month the Commission on Evidence-Based Policymaking published 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 it’s 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.

Zika Is Still An Underfunded Problem

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.

Health And Human Services Department Trying To Increase Access To Clinical Trial Data

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.

White House Seeking Stories For This Year’s Manufacturing Day

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.

White House Frontiers Conference To Look Forward And Back

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?

Cancer Moonshot Experts Submit Recommendations

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.