GHTC statement for WHA HHS Stakeholder Listening Session on diagnostics resolution

GHTC Statement for HHS Stakeholder Listening Session in preparation for the 76th World Health Assembly – Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordinationLast year’s clinical trial resolution was a major milestone for building greater clinical trial capacity in low- and middle-income countries (LMICs), and we appreciate the United States’ leadership in pushing for strong language for facilitating greater clinical trial coordination. However, implementation is still slow and ongoing, and there are several areas where the resolution could have gone further to address the public health needs of LMICs and support the needs of vulnerable populations.We therefore urge the United States to consider the following as member states continue to implement the agreed-upon recommendations and commitments made at the World Health Assembly last year:The resolution should have included stronger mandates for trial registration. Despite the World Health Organization’s (WHO’s) recommendations that all trials are registered, around half of all trial results are never published.The resolution underscores the need to better ensure clinical trials are targeted at treatments for diseases of global, regional, and national importance, but it does not outline what these are or how they can be identified. This should be addressed as the implementation framework is developed.We call on the United States to elevate the Global Health Security Agenda as a platform where LMICs can highlight bottlenecks, share best practices, and align around clinical trial and research and development capacity assessment needs.We would welcome a continued push by the United States for WHO and member states to address the inadequate reporting of data disaggregated by sex and gender relating to WHO’s priority pathogens, such as those for neglected tropical diseases and in WHO’s R&D Blueprint, as well as for new antibiotics for highly resistant pathogens.To fill gender equity gaps in research and better meet the health needs of these neglected populations, we encourage the United States to align with other member states to ensure WHO’s guidance on best practices for clinical trials is specifically focused on protecting persons of childbearing potential through and not from research, including during pregnancy and lactation. Lastly, we urge the United States to support the Global Accelerator for Paediatric Formulations and the WHO International Clinical Trial Registry Platform through data sharing and technical support.

The Defense Health Research Consortium April 24, 2023 The Honorable Ken CalvertThe Honorable Betty McCollumChairRanking MemberSubcommittee on DefenseSubcommittee on DefenseCommittee on AppropriationsCommittee on AppropriationsH-405 Capitol Building1016 Longworth House Office BldgWashington, DC 20515Washington, DC 20515 Dear Chair Calvert and Ranking Member McCollum: As you begin work on the fiscal year 2024 Defense Appropriations Act, we write to thank you and encourage you to continue your support for the critical and highly successful defense health research programs funded through the Congressionally Directed Medical Research Programs (CDMRP) at the Department of Defense (DoD).  While the CDMRP funds research to protect the men and women who serve in our Armed Forces, military families, veterans, and civilian populations from a wide range of medical conditions and health challenges, many of these programs are also directly related to preparedness and response to global pandemics.   We therefore encourage you to increase funding for these critical programs by five percent plus inflation, to ensure that our country is prepared to meet current and future public health-related threats and challenges to our national security.  An increase in funding is particularly vital to mitigate the impact of inflation on the purchasing power of individual CDMRP programs, particularly those programs that have been flat funded for several years. The highly innovative research portfolio supported by the CDMRP fuels scientific discovery by funding high impact research not sponsored by the National Institutes of Health (NIH), the Department of Veterans Affairs (VA) and other federal agencies. Many of the programs’ award mechanisms propel the exploration of revolutionary ideas and concepts.  Programs focus on the potential of having a significant impact upon both their respective fields of research and the health and well-being of the men and women in the U.S. Armed Services.  CDMRP awards grants to study many of the conditions – including kidney and pancreatic cancers and melanoma – added by the PACT Act as VA benefit presumptive service-related health conditions. Defense health research programs are worthy of continued federal support for the following reasons: Directly relevant to DoD-prevalent conditions: The medical research programs at DoD directly impact the health and lives of the U.S. military, their families, veterans and the public.  Programs provide groundbreaking research on psychological health, Gulf War Illness, respiratory health, burn pits and other toxic exposures, spinal cord injury, and hearing and vision loss, and newer conditions such as Long COVID. Research also focuses on existing and emerging infectious diseases that may threaten operational readiness and health security, and why diseases like ALS and multiple sclerosis occur at greater rates in those who have served in the military.  The defense health research program has also funded the orthopedic research program that has resulted in new limb-sparing techniques to save injured extremities and preserve and restore the functions of injured extremities. Letter to Chair Calvert/Ranking Member McCollumApril 24, 2023Page 2 Equally important, this disease-specific approach includes important medical research programs related to several forms of cancer (breast, blood, colorectal, bladder, brain tumors, lung, ovarian, prostate, stomach, liver, esophageal, rare and childhood cancers), autoimmune diseases and other disorders (like neurofibromatosis and tuberous sclerosis complex) that have led to breakthroughs on nerve regeneration, traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD). Complementary – and not duplicative – of other federal research:  Defense health research program grants neither duplicate nor supplant NIH or VA research efforts, but rather enhance those efforts. They fund highly innovative projects – support that is typically unavailable through other federal programs.  For example, programmatically- related VA research funding is only available to VA employees (at least 0.625 full-time equivalent). CDMRP funds the best-qualified proposals from researchers and research teams at top research universities and medical centers.  The NIH and DoD medical research portfolios have symbiotic relationships, allowing NIH-funded basic research to serve as a foundation for ground-breaking, disorder-targeted research at DoD.  NIH and DoD program officers meet regularly to ensure collaboration and prevent duplication. Cutting-edge and focused on cures:  While the NIH funds high-quality basic biomedical research, the defense health research programs provide essential emphasis on and support for finding innovative cures or new therapies for medical conditions.  For several disorders, DoD breakthroughs have led to new clinical trials, new drug products, and novel procedures that are making a difference in the everyday lives of affected patients and families.  For example, research funded by DoD led to the development of the only treatment for tuberous sclerosis complex approved by Food and Drug Administration. The ALS Research Program is supporting translational research and has developed four potential treatments for the disease, for which an effective treatment currently does not exist.  Enclosed is a detailed white paper providing many examples of breakthroughs by the various CDMRPs that have benefitted active-duty warfighters, veterans, military families and civilian populations. Agile, adaptable, and collaborative:  Each of the separate programs is guided by a specific vision and mission statement, which in addition to incorporating Congressional direction, reflect rapid change in knowledge, address research gaps, and prevent duplication.  Annual funding prevents out-year budget commitments, which in turn further enhances programmatic flexibility. Many DoD programs identify, develop and fund collaborative and consortium-based research, helping to bring unique, interdisciplinary, inter-institutional, collaborative efforts to bear on complex medical research issues unlikely to be solved though the inherent limits of individual researchers.  Letter to Chair Calvert/Ranking Member McCollumApril 24, 2023Page 3   Competitive and unique peer review process:  While Congress allocates funding through the annual Defense Appropriations Act to specific medical conditions, it does not direct the programs’ dollars to specific researchers.   These programs utilize an efficient multi-tiered process that includes multiple stages of peer review, including two levels of formalpeer review of final proposals. Proposals are scored in a number of key areas such as scientific merit and impact for patients and the military, providing a robust comparativebasis for helping accomplish the program’s mission of finding and funding the best research related to these important medical conditions. Consumer review: All defense health research programs incorporate the full and equal participation of consumer reviewers at every stage of the multi-tiered review process – a novel and valuable practice in medical research funding.   Consumers – people actually affected by the disease or medical condition – help ensure the program’s funded research will have the greatest impact on those who are affected.  Consumer reviewers also help inform and educate their disease advocacy communities and others.  Generating economic growth across the United States:Research activities promote job growth and encourage long-term economic development through innovation.It has been estimated that for every dollar awarded in biomedical research grants, more than $2 of additional business activity is created.  Defense health research grants are awarded to universities and institutes in every state in the country. In short, the well-executed and efficient programs within the defense health research programs demonstrate responsible government stewardship of taxpayer dollars and benefit current and former military service members, the general patient population, and our nation’s economy. Perhaps most importantly, DoD’s innovative approaches to funding biomedical research have led to several significant breakthroughs and achievements, contributing to national security and the health and welfare of U.S. Armed Forces personnel and their dependents.  Continued federal funding will only build on these successes. Lastly, we encourage timely enactment of the fiscal year 2024 Defense Appropriations Act, to ensure continuity in the defense health research programs.  We recognize the continuing challenges you must face to move appropriations bills through the “regular order” process.  However, we must continue to maintain continuity in investment in this important research to ensure that our nation is prepared for future pandemics and other public health challenges that threaten our current military populations and their families, as well as veterans and the general civilian population.   Letter to Chair Calvert/Ranking Member McCollumApril 24, 2023Page 4  Therefore, the undersigned respectfully request your support increasing the appropriation for defense health research programs by five percent plus inflation in the FY 2024 Defense Appropriations Act. Sincerely, ALS AssociationAmerican Academy of Allergy, Asthma & ImmunologyAmerican Academy of Dermatology AssociationAmerican Academy of NeurologyAmerican Academy of OphthalmologyAmerican Association for Cancer ResearchAmerican Association for Dental, Oral, and Craniofacial ResearchAmerican Association for the Study of Liver DiseasesAmerican Brain Tumor AssociationAmerican Cancer Society Cancer Action Network (ACS CAN)American College of Obstetricians and GynecologistsAmerican College of RheumatologyAmerican Gastroenterological AssociationAmerican Lung AssociationAmerican Psychological AssociationAmerican Society of HematologyAmerican Urological AssociationAmputee CoalitionAplastic Anemia and MDS International FoundationAPS Foundation of America, IncArthritis FoundationAsbestos Disease Awareness OrganizationAssociation of American Cancer InstitutesAsthma and Allergy Foundation of AmericaBeyond CeliacBladder Cancer Advocacy NetworkBlue Faery: The Adrienne Wilson Liver Cancer AssociationBrown UniversityThe Buoniconti Fund to Cure ParalysisCancer ABCsCase Western Reserve University School of MedicineCeliac Disease FoundationChildren's Tumor FoundationCholangiocarcinoma FoundationChristopher & Dana Reeve FoundationCoalition for Academic Scientific ComputationLetter to Chair Calvert/Ranking Member McCollumApril 24, 2023Page 5 Coalition for National Security ResearchConnect MelanomaCrohn's & Colitis FoundationCURE EpilepsyCureHHTDeadliest Cancers CoalitionDebbie's Dream Foundation: Curing Stomach Cancerdebra of AmericaDefense Health Research ConsortiumDuke HealthDuke UniversityECAN Esophageal Cancer Action NetworkEpilepsies Action Network (EANEpilepsy Alliance AmericaEpilepsy FoundationFD/MAS AllianceThe Fibroid FoundationFight Colorectal CancerFORCE: Facing Our Risk of Cancer EmpoweredFoundation for Peripheral NeuropathyFoundation to Eradicate DuchenneGlobal Health Technologies CoalitionGO2 for Lung CancerHarvard UniversityHepatitis B FoundationHIV Medicine AssociationHope for Stomach CancerHydrocephalus AssociationImmune Deficiency FoundationIndiana UniversityInternational Myeloma FoundationInternational Pemphigus Pemphigoid FoundationJohns Hopkins University & MedicineKidney Cancer AssociationKidneyCANThe LAM FoundationLennox-Gastaut Syndrome (LGS) FoundationThe Leukemia & Lymphoma SocietyLittlest Tumor FoundationLiving Beyond Breast CancerLUNGevity FoundationLupus and Allied Diseases Association, Inc.Lupus Foundation of AmericaLetter to Chair Calvert/Ranking Member McCollumApril 24, 2023Page 6 Lupus Research AllianceLymphoma Research FoundationMelanoma Research FoundationMesothelioma Applied Research FoundationThe Miami Project to Cure ParalysisThe Michael J. Fox Foundation for Parkinson's ResearchMichigan State UniversityNational Alliance for Eye and Vision ResearchNational Alliance of State Prostate Cancer CoalitionsNational Association of Nurse Practitioners in Women's Health (NPWH)National Autism AssociationNational Brain Tumor SocietyNational Fragile X FoundationNational Multiple Sclerosis SocietyNational Organization for Rare DisordersNational Scleroderma FoundationNeurofibromatosis MidwestNeurofibromatosis NetworkNorth American Spinal Cord Injury ConsortiumOncology Nursing SocietyOvarian Cancer Research AlliancePancreatic Cancer Action Network (PanCAN)Pandemic PatientsParent Project Muscular DystrophyPenn State UniversityProject 8p FoundationThe Prostate Cancer Clinical Trials ConsortiumProstate Cancer FoundationProstate Health Education Network, Inc. (PHEN)Pulmonary Fibrosis FoundationThe Quinism FoundationRare Epilepsy Network (REN)Research!AmericaThe Sergeant Sullivan CircleSHEPHERD FoundationSjogren's FoundationThe Society of Thoracic SurgeonsSociety of Gynecologic OncologySolve M.E.St. Baldrick's FoundationStony Brook UniversitySusan G. KomenSynGAP Research FundLetter to Chair Calvert/Ranking Member McCollumApril 24, 2023Page 7 SYNGAP1 FoundationTB AllianceTexas A&M Health Science CenterTexas Neurofibromatosis FoundationTSC AllianceUniversity of Colorado Anschutz Medical CampusUniversity of North Carolina SystemUniversity of PittsburghVasculitis FoundationVeterans for Common SenseVHL AllianceWayne State UniversityWeill Cornell MedicineZERO Prostate Cancer cc: Members of the U.S. House of Representatives  Enclosure: “Relevance to National Security and Military Families”