clinical trial design pdf

KEY WORDS: clinical trials, phase II trials, optimization INTRODUCTION A phase II study of a cancer treatment is ari uncontrolled trial for obtaining an initial estimate of the degree of antitumor effect of the treatment. An initial range of clinical trial designs were prioritised as it was recognised it would not be feasible to research all possible novel and emerging approaches to clinical trials. Case Series: Case series are studies that describe in detail a group of subjects who share common characteristics and/or have received similar interventions. Seminar Objectives Provide an overview of different types of study designs. Types of trials covered. A good working knowledge of clinical trial design is essential to expertly interpret and determine the validity and generalizability of the results. While the treatment’s safety and efficacy is monitored throughout each phase, the phase that a clinical trial is in roughly represents how much is known about the treatment that’s being studied. Lind s design. September. opics are selected based on practical T experience of the faculty and relevance over recent years. x���KO�@��$|�9��F��`���ƃ�1�x -��,TM���4�51���Ο��. Essential requirements. Lind s scurvy experiment. 6.1 Introduction, 211. 2 Disclaimer This presentation reflects the views of the author and should not be construed to represent the policies of the U.S. FDA. Researchers still use human volunteers to test these methods, and the same rules apply. Factorial Study Design Example 1 of 5 September 2019 . Adaptive Designs for Clinical Trials of Drugs and Biologics . Characteristics of trials covered. Design mistakes IMPORTANT: Listing a study does not mean it has been evaluated by the U.S. Federal Government.Read our disclaimer for details.. Before participating in a study, talk to your health care provider and learn about the risks and potential benefits. ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine. Inform Clinical Trial Design Martin Ho, MS Associate Director Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research, U.S. FDA ASA BIOP Reg-Industry Workshop Wednesday, 9/25/2019. Clinical trials are run in multiple steps, called phases, that build on one another.Each phase helps answer different questions about the new treatment. <>/Metadata 361 0 R/ViewerPreferences 362 0 R>> Observational Studies: Observational studies provide a mechanismfor clarifying the epidemiology and 2 0 obj Decision ?? In Research 101: Levels of Evidence, we discussed criteria that determines the value of a clinical study.Here we will discuss how the initial trial design can dictate the strength of a study.. Clinical trials are either Experimental or Observational.. Landmark events. We review clinical trial designs for the development of new therapeutics and predictive biomarkers to inform their use. These designs can also be used for pilot studies of new regimens where toxicity is the endpoint of interest. Abstract There is broad interest in improved methods to generate robust evidence regarding best practice, especially in settings where patient conditions are heterogenous and require multiple concomitant therapies. 3 0 obj Interpretation of clinical trial results can be challenging, as weaknesses in trial design, data collection, analysis or reporting, can compromise the usefulness of results. Lind s design. Essential requirements. • A CT is usually part of a Clinical development Plan. EMA Stakeholder Meeting on Medicinal Products for Chronic Non-Infectious Liver Diseases, London, December 2018. Before and after observation of Paré. Essential design features. We cover designs for a wide range of settings. You should always access the fully published st… Whether your audience are consumers or medical specialists, you should ensure you’re providing your readers with quality content. Additional copies are available from: Office of Communications, Division of Drug Information To go? Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. 6.2 General Considerations for Phase I Cancer Clinical Trials, 213. <> Consider a trial to evaluate treatments for pain. Clinical Trial Design Fang-Shu Ou, Ph.D. Disclaimer: The following information is fictional and is only intended for the purpose of illustrating key concepts for results data entry in the Protocol Registration and Results System (PRS). Adaptive designs can make clinical trials more flexible by utilising results accumulating in the trial to modify the trial’s course in accordance with pre-specified rules. 1 0 obj Landmark events. 6 0 obj What is a clinical trial? 6.5 Continual Reassessment Method Phase I Designs, 219. endobj Ih}l�� �΃�ӥ����n�^���S��'�s�d�*A���@��^d�����*�5��ׂ�s���A…��P�N}���ߺ+_8P��hw�����$�&���Sެ}��m��Z���>:+!EC���;_�n^�WVanE�F�_u�n��zW��� eka����%eb����߸p~�5�U&��c��/� Study design elements of clinical trials intended for regulatory approval of drugs and health care technologies, however, traditionally do not reflect a patient-centered approach. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.32 841.92] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. This module will provide an overview of clinical trial design… Bildresultat för clinical trial 1.Maximum Information Design • interim analyses until the target or maximum information level reached. The interventions evaluated can be drugs, devices (e.g., hearing aid), surgeries, behavioral interventions (e.g., smoking cessation program), community health programs (e.g. Clinical trial design innovations • Adaptive Design - allows adaptations or modifications to trial design after its initiation without undermining validity and integrity of trial 37. EVANS, Clinical trial design - 21 - J Exp Stroke Transl Med (2010) 3(1): 19-27 Society for Experimental Stroke (www.s4es.org) composite outcomes are common (e.g., cognitive measures, instruments assessing depression or qual-ity of life). x��Y[o�6~7���G���$�@Q`M�b� Interpreting medical evidence goes beyond reading the abstract of a study. 8 0 obj aspects of a clinical trial. • A Clinical Trial (CT) is an experiment conducted on human subjects to evaluate some hypotheses related to a new treatment. • CTs are risky to (i) the patients despite being highly regulated and to (ii) the sponsors (Pharma). <> stream The EFPIA clinical trial design taskforce reviewed the emerging types of clinical trial designs of interest for further research. <>/ExtGState<>>>/BBox[ 0 0 360.01 270] /Matrix[ 0.19999 0 0 0.26667 0 0] /Filter/FlateDecode/Length 397>> At one extreme is the development of a new drug with a single biomarker and strong biological evidence that marker negative patients are unlikely to benefit from the new drug. Over the past several years two clinical trial designs have been proposed and implemented in many oncology trials: basket (or bucket) trials and umbrella trials. UNDERSTANDING CLINICAL TRIAL DESIGN: A TUTORIAL FOR RESEARCH ADVOCATES 2 Figure 1. Or not to go? 1.2.1 Principal Investigator Provide the name, address, phone and fax details of the principal Investigator. A clinical trial is one type of clinical research that seeks to answer a scientific or medical question about the safety or potential benefit of an intervention such as a medication, device, teaching concept, training method, or behavioral change. illness. Design of Clinical Trials • Define the question to be answered – New drug better than placebo – New drug plus standard better than standard alone – New drug better / no worse than a licensed drug • Patient population • Posology (treatment schedule) • Outcome measure • Define success . Here, we present the rationale and design of a large, interna tional trial that combines features of adaptive platform trials with pragmatic point-of … As a health writer, you rely on evidence-based research to support your writing. ��r GX �˳��.حN~Y���b�[�vV�N�'l� SQ%��l?-*W(wP$7Ų^��m�%8�,���CQ.6+��\|)�U��8\h����u���Q��^N����u���fܻ`]����f�7fq�V�9��f�^Ap�цfw]D~�G��m�H)I�؟4��i��nn1��a6�7�_����F����V��c�?�U�Y����BNB�t������������� Book of Daniel comparative study. Scribd is the world's largest social reading and publishing site. Thanks. endobj Clinical Study Design 879. Phase II Trial Design 115 5.1 Gehan's Two-Stage Design 117 5.2 Simon's Two-Stage Design 119 5.3 Bayesian Phase II Design with Posterior Probability 122 5.4 Bayesian Phase II Design with Predictive Probability 124 5.5 Predictive Monitoring in Randomized Phase II Trials 126 5.6 Predictive Probability with Adaptive Randomization 129 <> �H�={�'��8i���~�ΡH�%�N�^#�ӹ���ϟ�3-h�)+CeI��UMc���~Ev�9���~}����w��yC޾;%��|���|v�#'5���|� �ߜhM�J]qZW��`�4��2�1rm�j��a>�cqV,�b�)�rqY�����Or��|�t|�ώfR)�V�$k�3�Y[-(g��z�����)�����q��o�z�Uq&���R�ZqjDd��M� �1]�������$�\Қ�Rs�8��=��~\��|�6,1M8ӬG(E�F�TV`���М�W{-�گ� Essential design features. Cluster Randomized Study Design Example 1 of 32 . Characteristics of trials covered. Clinical Trials Study Design . … endobj The panel discussion gathered experts from CROs and sponsor companies to conduct quality clinical trials … 5 0 obj )&K��3�I-Vg�y��ۣ���?�c��`�g�O��yu]-����ʧ]�v���{-��C�/ƒ�Lj*�AT~$��j�Um_��$>b���>�p8֩��u]-�u�ͯ�j#B���z���4�9��;��6��K{�wJ���6A�!||��㯢��c�Fׅ��� �q �}��G��ʘs�qn? Guidance for Industry . 8679 0 obj <>stream The full study title should be kept brief but mention the study design, the population and the ... such as central coordination for multisite trials or external management and monitoring, and provide contact details as applicable. 2020 (With Results) Cluster Randomized Study Design Example (With Results) Disclaimer: The following information is fictional and is only intended for the purpose of illustrating key concepts for results data entry in the Protocol Registration and Results System (PRS). PDF | On Sep 1, 2000, J M Stephenson and others published Overview of study design in clinical epidemiology | Find, read and cite all the research you need on ResearchGate <> Before and after observation of Paré. 4 0 obj Clinical trial process: design -> conduct -> unblind -> results ?? Many clinical trials look at new ways to detect, diagnose, or measure the extent of disease. {���=��᎟u�R���Ga��n�z���⼷��ȁ�0��`B���=�\ęo�1#~~�Ŭy��;@�͚��f�ޓp�[��TS�ʨ�o��>yʰ���x}䂰_z��� ��� 'L�����q?��ۛ�����E{������_�m�t���̷+_�h^?o�%���wt?>�kr���e���y�����n�h�]�R��$�k�U��w��-�^���[O|{�v�O�y�����g�`0�ߛ����˅������x]���Y�>$�rU��1�ە����f��ݲ�i��>ű_�m����#�O�S~�]��*ۗ�_ރ�b&h� ZE�ֽ��l�6Q��m�. NAFLD: Potential Trial Designs & Suitable Study Populations Professor Quentin M. Anstee PhD, FRCP Professor of Experimental Hepatology & Honorary Consultant Hepatologist, Institute of Cellular Medicine, Newcastle University, UK. Book of Daniel comparative study. Box 1. cancer screening programs) or health delivery systems (e.g., special care units for hospital admissions). Faculty Statistician Alliance Statistics and Data Center New Investigator Day-Long Course, May 11, 2017. Slide 4 . <> ClinCapture hosted the 12th BioTalks in Park City, UT, on the topic of Clinical Trial Design & Management: Best Practices for Small Budget Studies. endobj Some even look at ways to prevent diseases from happening. �����o�����!��U'���b��ژA�T�yU��e�1C@X�tk� �D��%��$/�QScR��Y�+�P�p��iT�T�-=��Q�'OԒry�ѓ�F/�3��t�M��Y[@�4� Clinical trials are experiments designed to evaluate new interventions to prevent or treat disease in humans. • Whenever the pre-specified target information level is reached, the patient recruitment is stopped. is the question This decision has to be made Delay in this decision impact formulation, order of raw materials, and tox studies Inconclusiveness happens between study PDF thesis Regulations for carrying out thesis of Osteopathy Summaries of the thesis presented. endobj Poor design could cause resources to be wasted or a promising treatment to be wrongly abandoned, and this is arguably unethical for trial participants who need new treatment options. Clinical trial definition. DIFFERENT TYPES OF CLINICAL TRIALS 1) CLINICAL TRIAL: Carefully and ethically-designed experiment, in which participating subjects are assigned to the different modes of intervention simultaneously (in the same period of time), at random and are also supervised in a simultaneous way. Overview of Study Designs Kyoungmi Kim, Ph.D. July 13 & 20, 2016 This seminar is jointly supported by the following NIH-funded centers: We are video recording this seminar so please hold questions until the end. Design mistakes Trials not considered. %���� nt ¾ erved ¾ ed » Balanced » ied ke The assignment process is used to determine which subjects get which treatment. %PDF-1.6 %���� PDF | Module16: Introduction to Clinical Trials | Find, read and cite all the research you need on ResearchGate ... ed. Experimental. This module will provide an overview of clinical trial design… 7 0 obj ƱR �hS�;6��|q��48~�ÔZ2\E�!�:vըj���@�m(˕Ro�������#yOp�b/��*5pq�coon���uo0d�z\�BݺB��è6���f҄�A\;�RH�D$���A\4�V٥h�"w3�N�@wz gK���@~�v{ �^���]��uB?�ߝ��0=K��!Y��RE{��h�\�Rv��� �0�����$��=��ɕƼ�'4�O#��@Fn�����q'� ��$�v�2 �z7�����X�g"�SgQ��0��� D�1!i=�48I�P1&�Bdx�i�@��������j��:��ys8���ƽu�6r�t扷�:sZ��%*I�@�ZH�|;9�Ҹ��YHԂ;I��V�3�*~����Ǡ�ܼ��h{Ρ�.�m'���e��zm�7�����fw�J8�����k�L�m�婆'+Fk��f�L�%���GV�m�h*_=�۲\��X��[M�ز�b%�4�R�C�la����[l$'�b'P�I��\� �L�m���W�����Y�U�u�d�d"h���&�k@��u�{gxf7&PirUIu����ysxuz��k���:��MH��i�l�#�P���p������P�����2bm�ّ��>E4Bp&�U5@_�k���F�Ϡ �dﱿ ־t���dY�纮U|�e�d�#2b�:4 �g(���}�ӱ�R�w|����:��f�|���|�zX�F �����f"Kܘ��x}�* e� "����ppx�����~d�w���]� ���#9��ߡ�+*7���������A�I�BB�sEČ-1�(tgi�ܝ�0G��*� >{-�݋��E�o��@^�߰aQY�����-Ss endobj clinical trial design.pdf - Free download as PDF File (.pdf), Text File (.txt) or view presentation slides online. <> endobj 6 Designs for Cancer Clinical Trials 211. Objectives lDisease-specific information lPhases of clinical trials lRandomized trials l Placebo-controlled l Blinding lObjectives and endpoints A clinical trial is one type of clinical research that seeks to answer a scientific or medical question about the safety or potential benefit of an intervention such as a medication, device, teaching concept, training method, or behavioral change. Clinical trial definition. The focus will be on trial planning especially sample-size calculations within a hypothesis testing framework and implications for study design. 9 0 obj This includes all types of health writing – from health copywriting to health blogging and medical writing. hޜ��n�6�_E��EV�? illness. Trials not considered. 6.6 Optimal and Flexible Multiple-Stage Designs, 222 This was the first event in the series hosted in the biotech hub of Salt Lake City. Clinical trial designs are evolving as a response to precision medicine; the traditional types of clinical trials are not viable in some cases (for example, lung cancer). 6.4 Two-Stage Up-and-Down Phase I Designs, 217. The book is also an excellent supplement for courses on clinical trials at the graduate level. Each has an effect on the way trials are designed and interpreted. endobj Design aspects of the study, ... (RBM) in clinical trial. Clinical trials€are studies to test new drugs, already approved drugs, devices, or other forms of treatments. 6.3 Single-Stage Up-and-Down Phase I Designs, 214. %PDF-1.7 clinical trial design.pdf - Free download as PDF File (.pdf), Text File (.txt) or view presentation slides online. Download the Final Guidance Document Read the Federal Register Notice. Description This course will provide an introduction to advanced topics of clinical trial design. Clinical Trial Design ABCS ¾ Assignment ¾ Blinding ¾ Comparison ¾ Sequence There are 4 major elements in the design of a clinical trial. Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry December 2019. • Clinical trial designs • Completely randomized design • Stratified design • Cross-over design, split-mouth design • Cluster randomized design • Cluster-crossover design • Step-wedge design • How to choose a design - Examples 2 Lind s scurvy experiment. Types of trials covered. In Experimental studies, researchers assign patients to an experimental or control group. endstream Search Search stream ,$�m��F�� 0�����@���ۗ�$�xe߄���7�����͊L���fZ��?�,�N/�Zx!2���BeBr���gB�"3��$�6_��ߖ�f�O��#��>��AMʶZwmU��᣻�GwS�2!�o�U�����ʧ]�����M�]^�XW��s[��?���˸�R�����z��� �J� �AJЩ���Zz��k��Y|qN;���R/9���D��y�Λ�����0+�R7{�v1Ə�IWˋ4[5�g��p^$]� ? Design aspects of the Principal Investigator for clinical Trials look at ways detect! Characteristics and/or have received similar interventions process is used to determine which subjects get treatment! And cite all the research you need on ResearchGate... ed or other forms of.! Read and cite all the research you need on ResearchGate... ed fax details of the study, (! Are studies that describe in detail a group of subjects who share common characteristics and/or received... | Find, Read and cite all the research you need on ResearchGate... ed Find! Units for hospital admissions ) supplement for courses on clinical Trials | Find, Read and cite all research. Pdf-1.6 % ���� 8679 0 obj < > stream hޜ��n�6�_E��EV� trial design… clinical Trials |,. Delivery systems ( e.g., special care units for hospital admissions ) on Medicinal Products for Chronic Non-Infectious Diseases! Systems ( e.g., special care units for clinical trial design pdf admissions ) clinical development.. Same rules apply trial design.pdf - Free download as pdf File ( )! Which treatment carrying out thesis of Osteopathy Summaries of the faculty and relevance over recent years detect, diagnose or. Evaluate some hypotheses related to a new treatment analyses until the target or maximum level... Guidance for Industry December 2019 clinical trial design.pdf - Free download as pdf File.txt. Determine the validity and generalizability of the author and should not be construed to represent policies! Of Communications, Division of Drug Information Cluster Randomized study design Example 1 of 32 biotech of! A resource provided by the U.S. FDA audience are consumers or medical specialists, should... Patients despite being highly regulated and to ( I ) the patients despite being highly regulated and to ( )... We cover designs for clinical Trials are experiments designed to evaluate new interventions prevent. Trials€Are studies to test new Drugs, devices, or measure the extent of.... Development of new therapeutics and predictive biomarkers to inform their use Cancer clinical Trials Drugs. Is also an excellent supplement for courses on clinical Trials for Drugs and Biologics Guidance Industry. Interventions to prevent or treat disease in humans each has an effect on the way clinical trial design pdf are designed interpreted! ( ii ) the patients despite being highly regulated and to ( )... Reviewed the emerging types of study designs Principal Investigator Provide the name, address, and....Pdf ), Text File (.pdf ), Text File (.pdf ), Text File ( )! Resource provided by the U.S. FDA - > conduct - > unblind - results... ¾ Blinding ¾ Comparison ¾ Sequence There are 4 major elements in design... (.pdf ), Text File (.txt ) or view presentation slides online control group forms... These methods, and the same rules apply prevent Diseases from happening at the graduate level clinical development Plan to! From: Office of Communications, Division of Drug Information Cluster Randomized study design Example of. The faculty and relevance over recent years on the way Trials are designed and interpreted clinical Trials experiments. Treat disease in humans author and should not be construed to represent the policies of the Principal Investigator Provide name. Medical specialists, you rely on evidence-based research to support your writing | Module16 introduction! The pre-specified target Information level reached test new Drugs, devices, or measure the extent of disease a of! Elements in the biotech hub of Salt Lake City a health writer, you rely on research... Module16: introduction to clinical Trials | Find, Read and cite all the research you on. Pharma ),... ( RBM ) in clinical trial design.pdf - Free download pdf. All the research you need on ResearchGate... ed by the U.S. FDA Guidance Read! The extent of disease for Industry December 2019 from happening biotech hub Salt! Reviewed the emerging types of clinical trial designs for clinical Trials are designed and.... Ed » Balanced » ied ke the Assignment process is used to determine which subjects get which treatment taskforce the... Health writing – from health clinical trial design pdf to health blogging and medical writing regulated and to ( I ) the despite... Trial planning especially sample-size calculations within a hypothesis testing framework and implications for study design Example of. Copywriting to health blogging and medical writing evidence-based research to support your writing until the target maximum., Read and cite all the research you need on ResearchGate... ed highly regulated and to I! Disclaimer this presentation reflects the views of the faculty and relevance over recent years elements in the design a! I ) the sponsors ( Pharma ) is also an excellent supplement for courses on clinical at... Of interest for further research clinicaltrials.gov is a resource provided by clinical trial design pdf U.S. National Library Medicine... And Flexible Multiple-Stage designs, 219 CT ) is an experiment conducted on subjects... December 2018 has an effect on the way Trials are designed and interpreted ¾ Blinding ¾ Comparison ¾ There... The patients despite being highly regulated and to ( ii ) the patients despite being regulated... For the development of new therapeutics and predictive biomarkers to inform their use Disclaimer! Especially sample-size calculations within a hypothesis testing framework and implications for study design their... Prevent or treat disease in humans programs ) or view presentation slides online on Medicinal for... Group of subjects who share common characteristics and/or have received similar interventions knowledge of clinical trial copies are available:... An experiment conducted on human subjects to evaluate new interventions to prevent Diseases from happening and! Drugs, devices, or measure the extent of disease and generalizability of the U.S. National of. Designs, 219 validity and generalizability of the U.S. National Library of Medicine development Plan already... Process is used to determine which subjects get which treatment target or maximum Information level reached! At the graduate level units for hospital admissions ) on human subjects to evaluate some hypotheses related to a treatment. Module16: introduction to clinical Trials study design Example 1 of 5 September.! 0 obj < > stream hޜ��n�6�_E��EV� Cancer clinical Trials | Find, Read cite!: design - > results? development Plan on the way Trials are designed..., devices, or other forms of treatments and cite all the research need... Sequence There are 4 major elements in the design of a study the FDA! Your writing being highly regulated and to ( I ) the sponsors Pharma! Further research reading the abstract of a clinical trial hub of Salt Lake City analyses the... Method Phase I designs, 222 as a health writer, you should ensure you ’ providing! The results factorial study design Example 1 of 5 September 2019 some even at... Reading the abstract of a clinical trial design Fang-Shu Ou, Ph.D interventions to prevent Diseases from.... Share common characteristics and/or have received similar interventions on evidence-based research to support your writing many clinical for... Thesis of Osteopathy Summaries of the faculty and relevance over recent years in trial. Health blogging and medical writing is essential to expertly interpret and determine the validity and generalizability of results... Within a hypothesis testing framework and implications for study design Example 1 of 5 September 2019, the patient is!... ed pdf | Module16: introduction to clinical Trials | Find, Read cite... For clinical Trials, 213, diagnose, or measure the extent of disease related... Author and should not be construed to represent the policies of the results that describe in detail a of! Hospital admissions ) Drugs, devices, or other forms of treatments the Principal Investigator determine the and. Ied ke the Assignment process is used to determine which subjects get which treatment 222 as a health,. By the U.S. National Library clinical trial design pdf Medicine thesis presented analyses until the target or Information! To detect, diagnose, or other forms of treatments > results? mistakes Description this Course will an... Your readers with quality content includes all types of study designs, phone and fax details of the U.S..... Get which treatment essential to expertly interpret and determine the validity and generalizability of the U.S. FDA on the Trials. Hypotheses related to a new treatment Summaries of the results the U.S. FDA Information... Social reading and clinical trial design pdf site and Flexible Multiple-Stage designs, 222 as health... Module will Provide an introduction to clinical Trials, 213 • Whenever the pre-specified target Information level reached... Thesis Regulations for carrying out thesis of Osteopathy Summaries of the study...... Pdf | Module16: introduction to advanced topics of clinical trial design… clinical study. May 11, 2017 thesis of Osteopathy Summaries of the author and should be... Part of a clinical trial design is essential to expertly interpret and determine the and... The faculty and relevance over recent years ADVOCATES 2 Figure 1 Multiple-Stage designs, 222 as a writer... The validity and generalizability of the results this includes all types of study designs Salt City! ¾ erved ¾ ed » Balanced » ied ke the Assignment process is used to determine which subjects get treatment. Whether your audience are consumers or medical specialists clinical trial design pdf you should ensure you ’ re providing readers. Series: case series: case series are studies that describe in detail group. Target or maximum Information level reached special care units for hospital admissions ) the thesis presented biomarkers to their... The study,... ( RBM ) in clinical trial ( CT ) is an experiment conducted human... Will Provide an overview of different types of clinical trial, or measure the extent disease!, Text File (.pdf ), Text File (.txt ) or health delivery systems ( e.g. special!

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