Use of the Internet to Provide Education and Training in Clinical Research
Post: July 9, 2012
Together with Underwriters Laboratory, we have launched CREATe (Clinical Research Education and Training) in the US, China, and India. We see particular value for this effort in Asia where the world of clinical research is rapidly expanding and the need is great for clinicians to learn and stay abreast of the fundamentals of how to participate in generating knowledge relevant to their practices. It is estimated that globally, the number of clinical research sites is growing at 15% per annum. CREATe has 3 fundamental levels: Tier 1 includes an introduction to clinical research, a review of key principles and GCP training; Tier 2 brings in a clinicians view of research methods, biostatistics and clinical trial design; Tier 3 focuses on analysis, dissemination, interpretation and application. The plan includes the educational program, a communication and collaboration portal and a registry of trained researchers and research sites. CREATe is not meant to produce independent investigators who can compete for peer-reviewed funding based on their views of study design. Rather, the goal is to produce a large workforce of healthcare providers and study coordinators who can contribute to the generation of knowledge by participating in clinical research, well informed not only about their regulatory obligations, but also about their roles as advocates for their patients in a complex world in which research sponsors have multiple motives.
We know that CREATe is not the only internet based effort to provide education about clinical research conduct, but we hope that it will contribute to a more effective global system of evidence generation and intelligent consumption of evidence in practice. Rhonda Larsen and Angela Rice-Warren have done a great job of bringing this together in conjunction with Krishna Udayakumar, DukeMed Global and the DCRI.
Its also clear that “internet only” will not suffice. It will be challenging, but we will need face to face reinforcement, especially in the context of trials conducted through the DCRI.
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Singapore
Post: July 8, 2012
After leaving Beijing last week, I made the pilgrimage to Singapore and wish to comment on 2 aspects:
- Duke-NUS School of Medicine: By all accounts this effort has been a success. It has been a team effort resulting in a first rate medical school that is breaking many barriers in the US-Asian differences in approaches to educating physicians and biomedical scientists. With a second class graduated, there is comfort that we are in it together for the long haul.
Many people know that I’ve been frustrated by the slow progress in clinical research. It seems to be the last frontier, when I think it should be one of the fundamental pillars of a medical school (after all, people come to doctors to help them decide what to do and to make sure the recommendations are enacted effectively—these are information-based disciplines and doctors should be educated to generate and consume evidence in their practice). Others, of course, argue that basic biological science should be the basis and clinical research should be added later—that’s what has happened in Singapore.
Be that as it may, on this visit I’m leaving optimistic about the path forward. In many ways, the issues in Singapore with developing a true academic medical center mirror our own issues in Durham—balancing the academic mission with the crushing need to deliver care. With Dr. Ivy Ng now in charge as CEO of the SingHealth system, I have confidence that the building blocks will be put into place to enable a gradual evolution of a first-rate system of clinical and translational medicine. It will still take time. Dean Ranga Krishnan has a lot more patience than do I, which is a good thing.
2. TEMASEK: I had a chance to spend time with Temasek, the investment corporation for the country of Singapore. This group is charged with investing Singapore’s national assets, much like the Duke Management Corporation (DUMAC) manages the Duke University’s investments. They have done a remarkable job of investing over the years and now have a large fund. I was impressed by the collegiality and breadth of knowledge of the staff and the joy they take in making money that then benefits the people of Singapore. It is easy to depict the down sides of a less free and open environment, but I believe we have a lot to learn from the amazing success of Singapore and the general collegiality of their people. A country of just over 5 million people with a huge global impact and a very high standard of living is obviously doing a lot of things right. I am grateful for the perspective of seeing a country with such dedication to achievement, amazing tolerance for religious difference, and approaches that encourage the melting of Western and Eastern approaches.
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China and Implementation Science–A Mutual Opportunity
Post: July 8, 2012
I am not an expert on China, but my several visits there have left distinct impressions about policies, activities and collaborations. If we think broadly about 3 areas of translation: bench to bedside and back, knowledge generation to determine what works and implementation of what works into effective healthcare delivery public health practices, there is merit in focusing on implementation because both countries have major gaps. The Duke Global Health Institute (DGHI) has done an amazing job in a short period of time in putting Duke on the global implementation science map.
Our Chancellor has caught the implementation science “bug”. In particular, leveraging his role in the World Economic Forum, he and Krishna Udayakumar have developed the Institute for International Partnership for Innovative Healthcare Delivery (IPIHD). Led by Duke, McKinsey and the World Economic Forum, the vision is to “Support innovators to scale, replicate successful innovative delivery solutions around the world, improving access to quality care at affordable cost”. The group is identifying not only what works, but studying models of successful delivery with a view that includes entrepreneurial development of delivery systems and business and financial models.
Until recently, I would have thought this is just a matter of the US “teaching China how to do it”. After all, we have many of the world’s most prestigious academic centers and public health efforts. However, an evaluation of the state of health of the 2 countries reveals that China is catching up quickly with the US in health statistics and that parts of the US are far below the national averages for China in measures like longevity and freedom from disability. IPIHD gives us a chance to see the world’s efforts and to adapt successful practices to the local cultural, financial, business and environmental landscape.
China has amassed massive financial resources, but it has major gaps in health status, as does the US. I hope we can find common ground to better understand how to solve these implementation issues.
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China: Collaborate or Compete?
Post: July 6, 2012
Many faculty have asked me why I’m spending time in China and whether its just a distraction from the everyday business of running an academic enterprise in North Carolina. Other than the fact that 1.4 billion people live there, I believe the time is right for collaboration for the benefit of both countries.
Like most major clinical research coordinating centers, we are conducting multiple clinical research projects in China. Most of our global trials have significant participation of Chinese sites. We have evolved through a period in which the efforts were considered novel into one in which much has been learned and new, more effective strategies can be developed in 4 key domains.
Over the past half-century, public health projects involving US collaborators or funders have been a part of the Chinese research landscape. Until recently, these efforts have been put forward as a chance for knowledge transfer from US (or Western European) universities into China. Now there is mutual transfer of information about public health, gene-environment interactions, and effective interventions. Linking of public health entities, such as our Global Health Institute with Schools of Public Health in China, can broaden our mutual knowledge base.
More recently, clinical trials funded by US industry or major academic centers were moved into China. Initially this approach represented arbitrage in which the sponsors could achieve substantial improvements in recruitment at much lower costs to “test” drugs and devices, often in the setting more “treatment naïve” patients. Over time, this situation has become much more complex and positive, as the Asian market is rapidly expanding and the Chinese themselves are developing drugs and devices for use in their own population and for expert to the West. Globalization, with the recognition that we all need to do relevant clinical trials for our populations and practice patterns, is replacing offshoring, which has a much more negative connotation.
Recently, China has been investing heavily in fundamental technologies for translational medicine. As capital has moved East and China has become a more significant direct participant in the global knowledge network, it is moving to become a leader. The scale of some of these investments is now unimaginable in the current environment in the US and Western Europe. By developing collaborations, we can enhance the degree to which we unravel the biological basis of health and disease.
Finally, we have a mutual interest in implementation science. Given an understanding of what works, both the US and China have enormous disparities in health outcomes and failure to deploy knowledge in the most effective manner. In many ways the US has been locked into a system which limits our ability to innovate, while the Chinese have an opportunity to create new systems with their rapidly changing society.
In my view we have 2 choices: 1) ignore China and hope it doesn’t overtake us or 2) collaborate wholeheartedly, always reflecting on what we are learning and what strategies will optimize our chances of both countries doing well. I think Option 2 is best, and its the chance to accelerate knowledge that makes the jet lag worth it!
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China: An Evolving Biomedical Giant
Post: July 5, 2012
Last week, I had the privilege of presenting a view of the role Duke could play as a collaborator in the annual Sino-American Science of Clinical and Translational Medicine (SAS-CTM) meeting in Shanghai. In this 3rd year of the meeting, it was really clear that China is continuing to make a huge investment in both technology and human capital in this area. We heard about 75 new translation medicine centers that have been funded by the government, massive biobanks, and significant investment in omics technology. The Ministry of Health, the Chinese Academy of Medicine, (its NIH equivalent) and its universities are applying major energy to the effort.
Almost all major American universities are developing collaboration with institutions and investigators in China, but few have an entire campus underway as we have with Duke-Kunshan University. Although this project has been controversial, I found our Chinese colleagues to be enthusiastic about what can be accomplished there.
I presented 5 key areas in CTM where Duke can play a role that will provide mutual benefit for Duke and for China:
- Participate in and coordinate global clinical and translational research projects
- Work with Chinese collaborators on sharing knowledge and developing policy on implementation science for health improvement
- Develop a physical presence as a university
- Disseminate fundamental knowledge about clinical research through internet based training and education
- Mutually develop the new workforce needed to drive translation, focusing on the quantitative discipline (biostatistics, informatics, clinical research, global health/epidemiology and health sector management)
I was heartened by the positive response at the meeting and the excitement about the potential for expanding our joint knowledge base.
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