20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage ra… Translational research is the research process that investigates and translates nonclinical research results into clinical applications and tests their safety and efficacy in a Phase 1 clinical trial. Preclinical and Animal Studies 2. h�bbd``b`6���=����@u@���� � n-�U R�$��A\��.�^n&F��y�T"��� � ��1 endstream endobj 991 0 obj <>/Metadata 104 0 R/OCProperties<>/OCGs[1007 0 R]>>/Outlines 145 0 R/PageLayout/SinglePage/Pages 984 0 R/StructTreeRoot 196 0 R/Type/Catalog>> endobj 992 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC/ImageI]/Properties<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 993 0 obj <>stream r,��`$����y��Ѭ��A�����l��)"@��FCXN������@ke�˷i^ �C�A�!��4c4c+ccc�cD��N{��D�0�pN3}�W���G��Mm�*�3�2��d�g� ����\�(c0 Ƈ:� h�bbd```b``�"��H�z�l/�ԂH�O R@D��HFk9�H2�����? 0 T1 research tests findings from basic research for clinical effect and/or applicability. h�b```�{,l�B �� T1 level research is designed to move basic discoveries to health applications, such as our work on shared decision-making for pediatric patients with chronic illnesses. In T2 level research, we test new therapies in controlled settings to provide guidelines for use in clinical settings. Human Physiology 3. 760 0 obj <> endobj 7`�DI�#���`I�:[}�%fˁ�����݉GS��n���w��c��94�H�062͠�Bj��D$��6�V�ɄT����1��"���X#2�p�Y����20�P8�O�+�$�H�z������r�����UB�W����T��u�\D��բ�G�!�������!��D4�Oe4�(���к���>�ћ/�oӦh�hV����;>����ׇ��I�~(f�H�g�T�Գ�MU�E�zR�+��uu{[��zV�i� [7�q|�B�-�&������rQ�~�6��U�usz_�D�Q�n�T4��O�11���������|3!��P�4���D�"MS��s Ο�V�8&��Ͷ6��Lt�5�]�ci U�B})�5�Q(�P�Y�G�q�}��-���G=� 9�z�@0/��8쇭_s��뛁us��P~��13���Ъ�QX���Q%�^�Vk��v�����7��rW�39�!ǃDG. %PDF-1.6 %���� 990 0 obj <> endobj ��nd���L�䊘'P�ń��i����@ZO++���j��-b�4e��p��v��\,M.T) z %%EOF • Developing treatments and interventions. One characteristic of safety biomarkers is that they are noninvasive and translate between species. Exemplified by: Human Physiology. �,��\X8�b 1006 0 obj <>/Filter/FlateDecode/ID[<20373F87D6E72947865F30085288739D>]/Index[990 26]/Info 989 0 R/Length 94/Prev 776445/Root 991 0 R/Size 1016/Type/XRef/W[1 3 1]>>stream endstream endobj startxref 793 0 obj <>stream • The interface between basic research and the clinical setting, striving to find how new knowledge of disease mechanisms can be developed into clinically relevant understandings, and diagnostic an… Basic research could cover a range of disciplines including: laboratory research, epidemiology, psychometrics, social science. T1 research yields knowledge about human physiology and the potential for intervention. T1. 776 0 obj <>/Filter/FlateDecode/ID[<3253F38F239BC34199FC467AAD4B49AB>]/Index[760 34]/Info 759 0 R/Length 81/Prev 159876/Root 761 0 R/Size 794/Type/XRef/W[1 2 1]>>stream %PDF-1.6 %���� • T1: initiates translation process; often case study research and Phase 1 & 2 clinical trials • T2: expands discovery to larger patient population seen in Phase 3 and 4 clinical trials • T3 relies on dissemination and implementation research to answer questions: Is treatment endstream endobj 761 0 obj <>/Metadata 44 0 R/OpenAction 762 0 R/Outlines 89 0 R/PageLayout/SinglePage/Pages 756 0 R/StructTreeRoot 108 0 R/Type/Catalog>> endobj 762 0 obj <> endobj 763 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/XObject<>>>/Rotate 0/StructParents 12/Tabs/S/Type/Page>> endobj 764 0 obj <>stream 1015 0 obj <>stream T1 research yields knowledge about human physiology and the potential for intervention. Phase I Clinical Trials: Tests a new biomedical intervention in a small group of people (e.g. %%EOF For example, the National Institutes of Health (NIH) describes translational research in two defined stages, defining T1 as “the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans” and T2 as “the research aimed at enhancing the adoption of best practices in the community.” A quantitative method of combining the results of independent studies, which are drawn from the published literature, and synthesizing summaries and conclusions. First in Humans (FIH) (healthy volunteers) 4. For purposes of the workshop, T1 translational research was defined as those studies that include basic discoveries carried to the point of first application to human subjects. @�F8��;$�;U220��g`$����O�'@� } / h�b```�;,,�� cb���� hTmO�0�+��41�;��*��@�V�$��zmD�VI�����nT-H���r����9c a�3�� ��"� ��($�������"�0ANN��-�Q�右z�TM��뗕�����4n��b��_��˞Z�� ;�wGϪ��S���)r5�A��P��=8t�2�ە �\�Ѳ^�����ct. Approaches include: 1. 9��.�}�8Qbc�jەR��� ����|�82�0|������瀈���\��B®�$K�Z�K<3�s�X�d�{��+y�V�)�V�Su���s���k��;����A��Y -m)+�p��rg"s��z�9������U9��Nd�#��M!�&+���zs�49��r%/�:d�uˉ`YΠCh�N3^`*���``Pr/���h`�Ł�0ɨ"!`&�8��(dS �`�Ȉv� �j���0]�"vH3�1����4��#ȚA�х�7�%��v������U���j��Nfte��x� �qB� ��,�!q��ݦ �X#�tww%�& �s����}�D�)@� ��& Proof of Concept (POC) 5. T1 Research: translation to humans, including proof of concept studies, Phase 1 clinical trials, and focus on new methods of diagnosis, treatment, and prevention in highly-controlled settings; T2 Research: translation to patients, including Phase 2 and 3 clinical trials, and controlled studies leading to clinical application and evidence-based guidelines; Translation to Humans. endstream endobj startxref - 3 With T1 translational research, findings from basic research are tested for clinical effect and/or applicability. 0 h��_o�6�� • The translation of basic research into research with humans.
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