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The role of clinical pharmacology and experimental medicine

The high failure rate of investigational compounds during drug development, especially in late stages of the clinical development process, is widely seen as a key contributor to the outsize amount of time and resources necessary to develop new drugs. Advances in clinical pharmacology and experimental medicine have the potential to rebalance these trends by providing researchers with the tools to more efficiently and systematically identify promising targets and compounds, appropriate patient populations, and adequate doses for study much earlier in development. 

On July 28, the Center for Health Policy at Brookings, in collaboration with the International Consortium for Innovation & Quality in Pharmaceutical Development and the U.S. Food and Drug Administration (FDA), hosted a public meeting to tackle these issues. Through presentations and case studies, leading experts from industry, academia, and government agencies explored the evolving role of clinical pharmacology tools in pre-clinical and clinical development, existing gaps in the application of those tools, and how emerging science could be better leveraged to improve the efficiency of drug development programs and better optimize treatments. Discussion at this event will potentially be harnessed to inform downstream guidance documents, to establish best practices for the application of emerging clinical pharmacology tools, or to support academic publications. Speakers will convene privately to discuss such downstream deliverables and key takeaways from the conference.

Click here to access the full event agenda.

Video

• Introductory keynotes: Framing the issues
• Optimizing target and compound selection to enhance early stage decision-making
• The right dose for the right patient: Challenges and opportunities in dose optimization
• Precision medicine: Trial enrichment, biomarker science, and mechanistic reasoning to optimize patient selection
• Applications of clinical pharmacology to support demonstration of efficacy

Event Materials

• Event Slide Deck
• Clinical Pharmacology Public Conference
• Clinical Pharmacology Backgrounder
• Clinical Pharmacology Private Roundtable

       

EXECUTIVE SUMMARY

Parents, educators, government ministers and policymakers in all contexts and countries around the world are concerned with learning and how to improve it. There are many reasons for this, but none is more important than the fact that learning is at the heart of success at the individual, community and global levels. Learning First is the title of this report, with the strong implication that learning should be the foremost goal of education policies worldwide.

The present review seeks not only to explain why this is the case but also focuses on what we need to know—that is, what research is needed—in order to improve learning in the decades to come, particularly among those children most in need. This question is addressed in the following six sections.

1. Learning Goals and Research. The first section begins with a historical synopsis of international education goals put forward in 1990 at the World Conference on Education for All in Jomtien (Thailand), in 2000 at the Education for All conference in Dakar, and later in 2000 as a part of the UN Millennium Development Goals for 2015. In 2011, the Center for Universal Education at the Brookings Institution published A Global Compact on Learning: Taking Action on Education in Developing Countries, which stated that there is a “global learning crisis—which affects children and youth who are out of school with limited learning opportunities and those who are in school but not learning the skills they need for their futures.” The present review of learning research in low-income countries follows from that report. The overall purpose is to explore the most pressing learning issues today that require further research attention in the years to come.
    
2. Learning Definitions and Contexts. This section reviews how the field of education has defined learning over the years. Here, learning is defined as a modification of behavior due to experience—such as in knowledge, skills, attitudes and values. Three main principles of effective learning are suggested: individual active involvement, social participation, and meaningful engagement. As a way to emphasize the importance of learning contexts, three individual stories—Illa, a four-year-old Quechua-speaking girl in Peru; Pawan, an eight-year-old primary school student in urban India; and Rachida, a young illiterate woman in rural Morocco—are provided in order to better explain the importance of learning as a culturally specific phenomenon. These stories help to illustrate a more general learning framework, encompassing the relationship between two dimensions of learning—its processes and contexts. A discussion follows concerning the need to disaggregate learners and their learning contexts—between countries and within countries—as a way to overcome frequent and simplistic generalizations about how the “average” child learns.
    
3. Global Change and the Contexts of Learning. This section considers the issue of global change on how learning and learning contexts are being transformed around the world. For example, researchers need to pay more attention to the impact of migration on children’s learning and on educational systems more broadly. In each instance of translocation, children confront the challenges of adapting to a new environment that may include different languages, dialects or cultures within the nonformal learning contexts of daily life. Similarly, in formal education contexts, student migrants have to cope with contrasts in culture, lifestyle and language of schooling, and demonstrate skills and achievement that may vary dramatically with their culture of origin. Other changes due to globalization include increased multilingualism in schools, growing overcrowding in classrooms, inability to keep up with teacher training, changes in intergenerational learning, and the growing importance of 21st-century skills. Based on these observations, it is suggested that learning contexts and needs should be understood as a shifting target.

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Youth summer jobs programs have experienced a resurgence of interest and investment since the Great Recession, driven by concerns about high unemployment rates among young people, particularly those who are low-income, black, or Hispanic. Recent research points to summer jobs programs as a positive lever for change by reducing violence, incarceration, and mortality and improving academic outcomes.They are often a jurisdiction’s most high-profile youth employment initiative.

But good intentions do not always lead to results. Research has not yet linked summer jobs programs to improved employment outcomes, evaluations to date are silent on effective program design, and in the absence of agreed-upon standards and best practices, there is no guarantee of quality.They are complicated and labor-intensive to operate, and many jurisdictions had to re-build their programs after a long hiatus following the end of dedicated federal funding in the late 1990s.

On Thursday, July 14, the Brookings Metropolitan Policy Program hosted an event that explored core elements associated with high-performing programs and made recommendations to strengthen summer jobs programs. The event featured a presentation on the finding of a new paper by Brookings fellow Martha Ross and co-author Richard Kazis, titled, “Youth Summer Jobs Programs: Aligning Ends and Means,” followed by a response panel, comprised of leaders from metro areas across the country.  

Join the conversation on Twitter at #SummerJobs

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Presentation by Martha Ross

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Photo

From left to right: Richard Kazis, Nonresident Fellow, The Brookings Institution; Kerry Sullivan, President, Bank of America Charitable Foundation; Honorable Michael A. Nutter, Former Mayor, City of Philadelphia;  Ana Galeas, Summer Camp Counselor, DC Scores, and Participant, Mayor Marion S. Barry Summer Youth Employment Program; Michael Gritton, Executive Directlor, KentuckianaWorks

Video

• Welcome and presentation
• Panel discussion
• Closing remarks

Audio

• Improving youth summer jobs programs

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• 20160714_youth_jobs_transcript

       

       

       

       

       

       

       

       

       

       

       

Five years have passed since several Arab countries revolted against their repressive regimes, and peace and stability are nowhere in sight. The unraveling of their political systems pushed these countries into challenging transition processes where violence is always a serious possibility. Yemen and Libya’s civil wars present blunt examples of failed transitions, raising concerns about protracted political instability, not only in those two countries, but potentially in neighboring ones as well. Tunisia theoretically managed to complete its transition successfully. It ratified a new constitution, addressing the need for a new social contract, and held two rounds of elections. Tunisia also passed a transitional justice law to provide a framework for adjudicating both victims’ grievances and perpetrators’ crimes of the past political era. Nonetheless, Tunisia finds its stability challenged by increasing levels of polarization between its various societal segments.

The fact of the matter is that political transitions take a long time—years if not decades—and transitioning countries face the risk of violence. Arab Spring societies are unlikely to transition to sustainable peace and stability as long as they are wracked by deep divisions. Therefore, national reconciliation is paramount to reducing the societal polarization that currently cripples Libya and Yemen and threatens Tunisia’s progress. To attain enduring peace and stability, post-revolution states must engage in inclusive national reconciliation processes, including a national dialogue, a truth-seeking effort, the reparation of victims’ past injuries, dealing with the former regime, and institutional reform. Women, civil society, and tribes, among other social forces, can support the transition process. Yemen, Libya, and Tunisia have each taken specific approaches to trying to reconcile their post-revolution societies, raising or diminishing the chances of civil war or a healthy transition.

An inclusive national dialogue is the starting point of a comprehensive national reconciliation process. It gives transitioning societies an opportunity to develop a vision and theoretical framework for their futures, gives legitimacy to transition processes, and encourages negotiation and compromise. Tunisia held a homegrown national dialogue driven mainly by civil society organizations and Yemen completed an eight-month, U.N.-assisted national dialogue conference. Libya’s engagement in U.N.-led negotiations raised questions over whether all parties had representation.

As each society suffered decades of repression and has a number of unanswered questions, investigating—and dealing with—the truth about the past is also essential. Relatedly, determining how to handle former regime elements has profound implications for post-revolution transitions. While Libya opted to purge all those who served in Muammar Qaddafi’s regime through adopting its “Political Isolation Law,” Yemen chose to grant President Ali Abdullah Saleh immunity from prosecution in return for his abdication—sacrificing justice to preserve peace. However, Saleh later returned to politics, allying with the Houthis to take over the state, meaning Yemen ultimately achieved neither justice nor peace. Tunisia, on the other hand, has adopted a transitional justice law that mandates, among other measures, the investigation and prosecution of the state’s crimes since 1955. While the resulting Truth and Dignity Commission has received thousands of complaints from victims of past abuses, progress has otherwise been slow, as the body has struggled to establish an effective organizational structure or execute a clearly defined work plan. Controversy over the selection of commissioners and an overall lack of publicity has also hindered the truth-seeking process.

Reparations are another important part of the pursuit of justice and healing. Done correctly, they can bring previously marginalized and abused segments of society back into the mainstream, where they can make positive contributions to the development of the country. Yemen and Tunisia experienced extensive human rights violations during the decades-long reigns of Saleh and Zine El Abidine Ben Ali, while lacking the resources to engage in meaningful and comprehensive rehabilitation of victims of past abuses. This left the two countries’ transition processes struggling with a major component—the victims—feeling further marginalization added to their past traumas. Libya, however, who has the resources to fund a process of thorough rehabilitation of victims of its dictatorship, slid into civil war that prevented the proper addressing of past wounds.

Even if these societies overcome their polarization at the personal level, however, they will not accomplish successful transitions unless their healing is accompanied by institutional reforms. “Regime renovation” rather than “regime change” in Yemen presented a serious obstacle to deep reforms of state institutions, eventually leading to some segments of security units taking part in Saleh-Houthi coup against the transitional government. After the collapse of the Qaddafi regime, revolutionaries and militias demanded a purge as a method of institutional reform—similar to de-Baathification in Iraq. The purge contributed to the outbreak of a civil war. Tunisia, on the other hand, approached institutional reform from a different angle and succeeded in putting together a sound formula, but it is facing serious challenges to implementation.

Ultimately, a variety of actors have played key roles in Libya, Yemen, and Tunisia’s national reconciliation processes. In all three countries, women have been integral to bringing about change, and must continue to be involved in reshaping their countries. As agents of change, women helped to initiate the uprisings in Yemen and Libya, and have already proven to be effective agents of reconciliation. In Yemen and Libya, tribes are key stakeholders that must be incorporated after decades of manipulation and marginalization. Depending on the way they become involved, tribes could play key role in either stabilizing or destabilizing transitions. Domestic civil society groups have been essential to Tunisia’s progress so far, and are fast developing in Yemen and Libya. Their continued involvement—and assistance from international groups—will go a long way toward consolidating new states that honor human and civil rights.

The processes of national dialogue, truth seeking, reparation, accountability, and institutional reform, especially if supported by key agents of reconciliation, including women, civil society, and tribes, can combine to create the momentum needed to bridge divides and help post-Arab Spring societies move toward sustainable peace, stability, and development.

This piece was originally published on the Yale Press Blog.

For more of Ibrahim Fraihat’s analysis on Yemen, Libya, and Tunisia after the Arab Spring, read his new book “Unfinished Revolutions” (Yale University Press).  

       

It’s easy to imagine a future in a decade or less when most people will have a smartphone. In our recent paper Pathways to Smarter Digital Financial Inclusion, we explore the benefits of extending financial services to the mass of lower-income people in developing countries who are currently dubious of the value that financial services can bring to them, distrustful of formal financial institutions, or uncomfortable with the treatment they expect to receive.

The report analyzes six inherent characteristics of smartphones that have the potential to change market dynamics relative to the status quo of simple mobile phones and cards. 

Customer-Facing Changes:

1. The graphical user interface.
2. The ability to attach a variety of peripheral devices to it (such as a card reader or a small printer issuing receipts).
3. The lower marginal cost of mobile data communications relative to traditional mobile channels (such as SMS or USSD).

Service Provider Changes:

4. Greater freedom to program services without requiring the acquiescence or active participation of the telco.
5. Greater flexibility to distribute service logic between the handset (apps) and the network (servers).
6. More opportunities to capture more customer data with which to enhance customer value and stickiness.

Taken together, these changes may lower the costs of designing for lower-income people dramatically, and the designs ought to take advantage of continuous feedback from users. This should give low-end customers a stronger sense of choice over the services that are relevant to them, and voice over how they wish to be served and treated.

Traditionally poor people have been invisible to service providers because so little was known about their preferences that it was not possible build a service proposition or business case around them. The paper describes three pathways that will allow providers to design services on smartphones that will enable an increasingly granular understanding of their customers. Each of the three pathways offers providers a different approach to discover what they need to know about prospective customers in order to begin engaging with them. 

Pathway One: Through Big Data

Providers will piece together information on potential low-income customers directly, by assembling available data from disparate sources (e.g. history of airtime top-ups and bill payment, activity on online social networks, neighborhood or village-level socio-demographic data, etc.) and by accelerating data acquisition cycles (e.g. inferring behavior from granting of small loans in rapid succession, administering selected psychometric questions, or conducting A/B tests with special offers). There is a growing number of data analytics companies that are applying big data in this way to benefit the poor.

Pathway Two: Through local Businesses

Smartphones will have a special impact on micro and small enterprises, which will see increasing business benefits from recording and transacting more of their business digitally. As their business data becomes more visible to financial institutions, local firms will increasingly channel financial services, and particularly credit, to their customers, employees, and suppliers. Financial institutions will backstop their credit, which in effect turns smaller businesses into front-line distribution partners into local communities.

Pathway Three: Through Socio-Financial Networks

Firms view individuals primarily as managers of a web of socio-financial relationships that may or may not allow them access to formal financial services. Beyond providing loans to “creditworthy” people, financial institutions can provide transactional engines, similar to the crowdfunding platforms that enable all people to locate potential funding sources within their existing social networks. A provider equipped with appropriate network analysis tools could then promote rather than displace people´s own funding relationships and activities. This would provide financial service firms valuable insight into how people manage their financial needs.

The pathways are intended as an exploration of how smartphones could support the development of a healthier and more inclusive digital financial service ecosystem, by addressing the two critical deficiencies of the current mass-market digital finance systems. Smartphones could enable stronger customer value propositions, leading to much higher levels of customer engagement, leading to more revelation of customer data and more robust business cases for the providers involved. Mobile technology could also lead to a broader diversity of players coming into the space, each playing to their specific interests and contributing their specific set of skills, but together delivering customer value through the right combination of collaboration and competition.