Benefits, Privacy, and Implementation of the Mesothelioma Patient Registry

Doctor speaking to patientLast week, we announced the important news that Congressman Katko introduced in Congress a bill to create a mesothelioma registry. You can read the news announcement here, and the full text of the bill here.

Benefits
The creation of a registry for mesothelioma is crucial for the advancement of the mesothelioma science and development of effective treatments for this cancer. Other conditions, diseases, and cancers have seen incredible progress and increased life expectancy of their patients as a result of registry implementations. Patient registries have played a crucial role especially for diseases that are considered rare and for which scientists have a difficult time accessing enough data to conduct their research (or, for example, for which it is difficult to find enough patients to enroll in clinical trials in order to complete them). Researchers around the world need disease registries to bring together information about relatively rare diseases, such as mesothelioma. To that end, the Global Rare Diseases Patient Registry Data Repository (GRDR®) is a process that allows the creation of a registry for any rare disease population.  The needs and background are explained here by the NIH.

Privacy
The language in the ‘Mary Jo Lawyer-Spano Patient Registry Act of 2015’ states:

The Secretary shall ensure that privacy and security protections applicable to the registry under this section are at least as stringent as the privacy and security protections under HIPAA privacy and security law (as defined in section 3009).”

The goal of a patient registry is to provide scientists with information they need to advance their research. However, this information is strictly safeguarded and only made available to scientists through a process by which they have to apply and demonstrate their particular relevant and valid need for these data. Also, all data is de-identified, meaning that patients’ names are stripped away from other information, and are instead replaced by unique numbers.

De-Identification
De-identification is the process used to prevent a person’s identity from being connected with information. Common uses of de-identification include human subject research for the sake of privacy for research participants.

Implementation
The language in the bill itself requires that the registry be created in consultation with the following experts in mesothelioma and registry creation:

“(1) epidemiologists with experience in disease surveillance or registries;
“(2) representatives of national voluntary associations that focus on mesothelioma or have demonstrated experience in research, care, or patient service for mesothelioma;
“(3) health information technology experts or other information management specialists;
“(4) clinicians with expertise in mesothelioma; and
“(5) research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes.

General Patient Registry Information
To learn more about patient registries, please visit the following links on the National Institutes of Health (NIH) website:

Registry FAQs by the National Institutes of Health

How Do Registries Work?

Take action now, and ask your congressional representative to support this bill!

NIH to Start Enrollment for Precision Medicine Research

Patient ResearchIn his most recent State of the Union address, President Obama announced a bold new research effort to revolutionize how we improve health and treat disease. According the White House website, the Precision Medicine Initiative, as it’s called, will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

Last week, we learned that the one million patient research cohort at the National Institutes of Health (NIH) could begin enrolling patients in the next fiscal year.

As noted by the NIH, “Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. Many efforts are underway to help make precision medicine the norm rather than the exception.”

The NIH is currently finalizing a plan for the cohort that will be reviewed by their research advisers and then must receive a sign-off from NIH Director Francis Collins.

Kathy Hudson, NIH’s director for science, outreach, and policy, believes the funding for the cohort will be approved by Congress, noting that Senate and House appropriators will invest $200 million for the Precision Medicine Initiative.

In addition to necessary funding, the cohort initiative will require policy updates, including those for protection of human research participants. Also, patient access to fully interoperable electronic health records will need to be improved.

As the original Politico article notes, “Hudson said NIH is working with the Senate to include any necessary policy updates for the initiative into its biomedical reform legislation. The chamber’s work is expected to ultimately synch with the House’s recently passed 21st Century Cures bill.”

For more information on precision medicine and the Precision Medicine Initiative, visit nih.gov/precisionmedicine.

2015 Symposium to be Co-Hosted with the NCI and Held at the NIH

International Symposium on Malignant MesotheliomaThis year, the Meso Foundation has partnered with the National Cancer Institute (NCI) to co-host the International Symposium on Malignant Mesothelioma. As a result, the conference will be hosted on the grounds of the National Institutes of Health (NIH) in Bethesda, Maryland. The NIH is one of the world’s foremost medical research centers.

This conference is geared to attendees from all walks of life, including patients and their families, advocates, medical professionals, those who have lost loved ones to mesothelioma, and scientists. The Symposium provides a unique setting for everyone in the meso community to come together, learn about mesothelioma and its treatments from renowned experts, build friendships and socialize.

The Symposium will be held from March 2nd through 4th at the NIH and the Hyatt Regency Bethesda. Daytime Symposium sessions will be held on the NIH campus, while evening dinners will be held at the Hyatt Regency Bethesda. The NIH campus is located only a few minutes away from the hotel, and we will provide shuttles between the two locations in the morning and afternoon of March 2nd and 3rd. Symposium attendees can also travel between the locations via Metro (stops are convenient to both the hotel and the NIH) or by taxi.

Register

Sessions will cover a range of topics about pleural and peritoneal mesothelioma, treatments, clinical trials, surgery, prevention, as well as support groups, well-being and community sessions. A mesothelioma Advocacy Day will be held on Capitol Hill on Wednesday, March 4th. View the full Symposium agenda here.

In addition to our science and treatment sessions for the general public, this year’s Symposium includes a two-day special session for scientists and medical professionals. Nearly 100 mesothelioma experts will come together to share their work, and find collaborative opportunities, in an effort to speed up mesothelioma advances. The scientists and medical professionals in attendance will be available during sessions common to both groups, such as lunches and dinners, to answer any questions and to socialize. A recap and “translation” of the sessions for scientists and medical professionals will be presents on Tuesday evening in the main Symposium session for the general public.

It is a privilege and an honor to host our Symposium on the campus of the National Institutes of Health, and we hope to see you all at the event. Learn more about the Symposium at curemeso.org/symposium or register here.

Meso Foundation Updates its Peer-Review for Research Grant Funding

ResearchAs the only non-government funder of peer-reviewed mesothelioma research, the Meso Foundation has announced an update to its peer-review process for evaluating research grant proposals, so as to once again match the process by the National Institutes of Health (NIH).

The Foundation has always modeled its peer-review process after the NIH, so when the NIH made changes in 2013, the Foundation followed suit.

The change involves streamlining the reviews by eliminating the two-step process and replacing it with one step only. Instead of sending a project through two separate rounds of review, which would usually result in a total of 3-4 number of reviewers looking at each project, now all 3-4 reviewers evaluate the project in the one and only round. This ensures a quicker review turnaround and a more efficient process.

To learn more about the Meso Foundation’s research grant program, visit curemeso.org.

Congress Exhibits Bi-partisan Support for NIH Funding in both House and Senate

Advocates on Capitol HillAs Congress works to map their federal spending for Fiscal Year 2015, advocacy organizations and members of Congress alike have been announcing their funding priorities for next year. The Meso Foundation has joined One Voice Against Cancer (OVAC) in asking for $32 billion in National Institutes of Health (NIH) funding, asking that Congress “end the erosion of cancer research funding.”

We are pleased to see that 186 members of the House, including 23 Republicans, support our funding request in a letter to the chairs and ranking members of both the full House Appropriations Committee and its Labor-HHS subcommittee. The letter, organized by Reps. David McKinley (R-W.Va.), Susan Davis (D-Calif.), Andre Carson (D-Ind.), and Peter King (R-N.Y.), requests that NIH receive “at least $32 billion” in FY 2015, stating:

We feel this amount is the minimum level of funding needed to reflect the rising costs associated with biomedical research. Full funding for NIH is critical if the agency is to continue to serve as the world’s preeminent medical research institution and our best hope for finding cures, improving treatments, and gaining a better understanding of the complex causes of diseases that affect millions of Americans….

The majority of the Senate (57 Senators, including 11 Republicans) signed a similar letter on April 3rd requesting the chairs and ranking members of the Senate Appropriations Committee and Labor-HHS subcommittee “maintain a strong commitment” to funding for NIH. While the letter organized by Bob Casey (D-PA) and Richard Burr (R-NC) does not mention a specific funding level for NIH, it urges appropriators “to consider the tremendous benefits of a sustained investment in the NIH.”

The Meso Foundation thanks these members of Congress for their public support of NIH funding.