This sweet reminder of God's comfort is a beautiful gift for a loved one in need of encouragement. Prose from writers such as the psalmists, Josephine Currier, and Fanny Crosby is woven tenderly with artwork that gently carries one to the shelter beneath the wings of love.

"I long...to take refuge in the shelter of your wings."

The Book of Psalms

One of the most encouraging metaphors for divine love is that of finding shelter under the protection of God's wings. On every page of this uplifting gift book, the gentle artwork of Carolyn Shores Wright tenderly reminds readers that God cares not only for the birds of the air but so much more for His children.

Loving quotations, reassuring Scripture, and calming prose thoughtfully express the message that God longs to show compassion and care, rest and refuge to those who are hurting. A comforting gift for anyone experiencing illness or suffering a recent loss in their lives.

Sharing knowledge is what drives scientific progress - each new advance or innovation in biomedical research builds on previous observations. However, for experimental findings to be broadly accepted as credible by the scientific community, they must be verified by other researchers. An essential step is for researchers to report their findings in a manner that is understandable to others in the scientific community and provide sufficient information for others to validate the original results and build on them. In recent years, concern has been growing over a number of studies that have failed to replicate previous results and evidence from larger meta-analyses, which have pointed to the lack of reproducibility in biomedical research. On September 25 and 26, 2019, the National Academies of Science, Engineering, and Medicine hosted a public workshop in Washington, DC, to discuss the current state of transparency in the reporting of preclinical biomedical research and to explore opportunities for harmonizing reporting guidelines across journals and funding agencies. Convened jointly by the Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Genomics and Precision Health, the workshop primarily focused on transparent reporting in preclinical research, but also considered lessons learned and best practices from clinical research reporting. This publication summarizes the presentation and discussion of the workshop. Table of Contents Front Matter 1 Introduction 2 Transparency and Trust 3 Approaches to Cultivate Transparent Reporting in Biomedical Research 4 Lessons Learned and Best Practices 5 Checklists and Guidelines 6 Toward Minimal Reporting Standards for Preclinical Biomedical Research 7 Stakeholder Opportunities for Promoting Transparent Reporting Appendix A: References Appendix B: Background Discussion Document: Selected Guidelines for Transparent Reporting Appendix C: Workshop Agenda

The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands. Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021. Table of Contents Front Matter 1 Introduction 2 Defining the Vision 3 Enhancing Outcomes in a More Person-Centered and Inclusive Clinical Trials Enterprise 4 Practical Applications for Technology to Enhance the Clinical Trials Enterprise 5 Building a More Resilient, Sustainable, and Transparent Clinical Trials Enterprise 6 Opportunities for Transformation References Appendix A: Health Affairs Blog Posts Appendix B: Speaker and Moderator Biographies Appendix C: Workshop Agendas

There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population. On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop. Table of Contents Front Matter 1 Introduction 2 Inclusion of Older Adults in Clinical Trials: An Evolving Landscape 3 Overcoming Key Barriers 4 Alternative Study Approaches 5 Strategies for Engaging Older Adults in Clinical Research 6 Clinical Trials in the Era of COVID-19 and Beyond 7 Reflections and Key Takeaways Appendix A: References Appendix B: Workshop Agenda Appendix C: Speaker Biosketches

Investment and innovation in drug research and development (R&D) for highly prevalent chronic diseases has stalled in recent decades, despite half of all Americans living with at least one chronic disease. As a result, prevalent chronic diseases are producing immense health care costs as well as preventable suffering and death. On February 22, March 2, and March 8, 2021, the National Academies of Sciences, Engineering, and Medicine, convened a workshop to discuss barriers to innovation in this space and examine strategies and incentives to support equitable, person-centered drug R&D for prevalent chronic diseases. Table of Contents Front Matter 1 Introduction 2 Person-Centered Drug Research and Development 3 New Technologies to Enable Research in Prevalent Chronic Disease 4 Investment and Incentives 5 Learning from Success 6 Lessons Learned for the Future 7 Reflections and Final Thoughts Appendix A: Workshop Agenda Appendix B: Biographical Sketches of Workshop Speakers

On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 Perspectives on Current Data-Sharing Policies in Practice 3 Data-Sharing Platforms 4 Striking a Balance Between Benefit/Value and Risk/Cost 5 Data Interoperability and Platform Usability 6 Infrastructure Sustainability 7 Challenges and Disincentives for Sharing and Reuse of Data 8 Finding Value in Sharing Clinical Trial Data: Overcoming Usability and Sustainability Challenges 9 Looking Forward: Incentivizing Data Sharing and Reuse Appendix A: References Appendix B: Workshop Agenda

Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series. Table of Contents Front Matter 1 Introduction 2 Perspectives on Real-World Evidence 3 Learning from Success 4 Barriers and Disincentives to the Use of Real-World Evidence and Real-World Data 5 Getting Unstuck: Mythbusting the Current System 6 When Is a Real-World Data Element Fit for Assessment of Eligibility, Treatment Exposure, or Outcomes? 7 How Tightly Should Investigators Attempt to Control or Restrict Treatment Quality in a Pragmatic or Real-World Trial? 8 Obscuring Intervention Allocation in Trials to Generate Real-World Evidence: Why, Who, and How? 9 Gaining Confidence in Observational Comparisons 10 Looking Ahead References Appendix A: Related Resources Appendix B: Workshop One Agenda Appendix C: Workshop Two Agenda Appendix D: Workshop Three Agenda