| 1 | Harvard Catalyst | Understanding the Spectrum of Translational Research | 27196 | 211 | 1 | 49.8 | negative | 3:21 | Opening a pill bottle and reaching for a medication is easy to take for granite. This simple act is made possible by the work of clinical investigators. But how to treat men such as drugs, devices, and diagnostics develop from an experiment on a lab bench to a product that improves patient health. The process of bringing a discovery from bench to bedside is called clinical and translational research. Clinical and translational research can be divided into four phases or T domains. Each has its respective characteristics, but many researchers believe that their work overlaps into multiple domains. The phases of the T domains are different than the phases of clinical trials, but they follow a similar path. Scientists spend years in laboratories testing a new treatment using animal models. This is sometimes referred to as T0. If the treatment shows promise, researchers will give the drug to humans for the first time. This step is the first phase of clinical and translational research, called T1 research. In this phase, researchers seek to evaluate the safety profile of the drug. To do this, they give the drug to a small group of healthy volunteers to see how the body reacts to it. This research is often conducted through phase one and some phase two clinical trials. To see if the drug is effective, T2 researchers give the new treatment to patients who had a disease researchers are interested in. T2 studies are bigger than T1 with hundreds of people at multiple medical centers receiving the new experimental treatment. These larger studies make up phase two and three clinical trials. The results from these studies help to establish guidelines for how to use the drug in the future. If the new treatment is effective, it receives FDA approval. Doctors can now prescribe the drug in practice and we have moved into the T3 domain. T3 researchers use the guidelines developed in T2 to teach doctors how to administer the drug in hospitals and medical centers. At this point, the new drug is used on thousands of people. Because other drugs may treat the same disease, T3 researchers compare the cost and effectiveness of the new treatment to treatments that already exist in routine practice. Researchers also start phase four clinical trials to continue to watch patients who take the drug to make sure there aren't any negative side effects. The new drug is safe, effective, has been approved, and is being widely prescribed. In the T4 domain, scientists study how the new treatment affects global public health. Researchers continue the phase four clinical trials that they started in T3 and study thousands of people all over the world to see how the drug is working. T4 researchers often observe whole communities to try to figure out what may be causing the disease in the first place. What researchers learn in T4 studies can often even change public policy. The pill has finally made it into mainstream treatment, but the path to get here was not easy. The process of developing a new intervention takes an average of 10 to 15 years and costs at least 1 billion US dollars. It's hard to believe that only a small fraction of interventions make it through all four domains. And most new treatments don't follow the process smoothly in one direction. Often discoveries made in one domain may necessitate that researchers backtrack into earlier phases. Although the road is long, clinical and translational research can have enormous impact on human health. | ↗ |
| 2 | Harvard Catalyst | Online course: Fundamentals & Applications of Clinical and Translation... | 688 | | | 42.0 | | 1:52 | We face a tremendous challenge in the 21st century. Many serious diseases and conditions remain uncured and untreated, devastating people's lives in our home communities and around the world. Researchers are uniquely qualified to find innovative solutions to this challenge. They work around the clock to discover, investigate, and deliver interventions that address these diseases and conditions. For those interested in research careers, it's critical to understand the concept of research. So where does a researcher get started? What exactly is clinical research? And how do you decide which type of research you'd like to specialize in? Harvard Catalysts Fundamentals and Applications of Clinical and Translational Research, or Factor, covers these topics and more. This 18-week online course featuring a mix of lecture videos, assessments, and resources, covers the application's spectrum of CT research, from first in human studies to healthcare interventions implemented on a population level. By the end of the course, participants are able to identify the key research methods used in CT research, including designing research studies, identifying ethical issues, communicating findings, and funding research. To learn more and register for fundamentals and applications of clinical and translational research, please visit the link below. Thank you and happy learning. | ↗ |