Protocol Designing for scientific research

Information about Protocol Designing for scientific research

Published on August 7, 2014

Author: dixitkumarrakesh

Source: authorstream.com

Content

Protocol Designing: Prof. R.K. DIXIT Pharmacology and Therapeutics K.G.M.U. Lucknow [email protected] Protocol Designing PowerPoint Presentation: Scientific approach It combines induction and deduction together with other methods to create a system of acquiring knowledge that is reliable. Function of science Includes development of theory and testing of substantive hypotheses deducted from theory or data. What Is Research? Research is a systematic investigation, involving the collection of information (data), to solve a problem or contribute to knowledge about a theory or practice. It applies the scientific approach to the study of a question of interest and relies on methods and principles that will produce credible and verifiable results . PowerPoint Presentation: Steps In Research (Scientific Approach) Identify the question or problem Conduct a literature review Frame a hypothesis Develop the study design Complete the research Analyze the data Generate conclusions What is Protocol?: What is Protocol? The term  protocol  is derived from the Greek word ( prōtos  'first' +  kolla  'glue‘). protokollan   'first page, flyleaf‘ (first glue). Act of gluing a sheet of paper to the front of a document to preserve it when it was sealed. What is Protocol?: What is Protocol? Protocol - has several meanings. Society- Etiquette Formal agreement between nation states Written record of a meeting Science- A predefined written procedural method of conducting experiments (Road Map to medical research…………………………..) Medical protocol -guidelines for medical treatment, Investigations Communications- A set of rules and regulations that determine how data is transmitted, Others- Safety protocols;  Academic protocol. The most common meaning of  protocol  is {“A system of rules that explains the correct conduct and procedures to be followed ” } WHAT IS A PROTOCOL?: WHAT IS A PROTOCOL? A protocol is a document that explicitly (fully and clearly expressed) states the The proposed research Question (What……) Reasoning behind (Why……………) Structure of a research project. (How……..) Protocol is also defined as a document that describes the background, rationale, objective, design, methodology, statistical considerations and organization of a research. It is a written mechanism that describes how a research design will be implemented. Why do we need a Protocol?: Why do we need a Protocol? Scientific validity Subject safety Replicate the science if necessary Regulatory requirements To clarify the research question To compile existing knowledge To formulate a hypothesis and objectives To decide about a study design To clarify ethical considerations To apply for funding To have a guideline and tool for the research team Elements of A Protocol: Elements of A Protocol A typical protocol has the following elements:- Title page (Including Date and Version and Protocol number). (Title- Accurate, Short, Concise, Descriptive:) Signature page Background information and scientific rationale (Literature Review) Aims and Objectives (Primary, secondary and SMART ) S pecific M easure something A ction oriented R elevant T ime specified Study design Study population Study procedures Materials and Methods Endpoints (Primary, Secondary Surrogate), Stopping Rules, Duration, Drug/ Device/ schedule, precautions, Subjects (inclusion/exclusion, withdrawal criteria) Safety Assessments, Animal keeping, handling, models, procurement of animals and chemicals, instruments, methods used where PowerPoint Presentation: Others- Literature references Supplements/ Appendices List of Abbreviations Informed consent process Subject confidentiality Compliance statement- Stating that the study will be according to GCP, GLP guidelines Statistical considerations- (At the time of planning of study, sample size, test for finding significance etc.) Ethical consideration- (Do Not Harm and Humanitarian approach, Animal /Human Ethics committee clearance) Time consideration - (Specific dates to achieve specific targets) Budget consideration- Rationale, Justifiable (Man, Money, Material) PowerPoint Presentation: Insurance consideration Certificate (MOU) - from the sponsor and from the other institute or laboratory Publication of research findings Conflict of Interest Case Record Forms (CRFs) Patient information form (in required languages) Questionaires Consent form (in required languages) Curriculum Vitae of investigators Protocol Summary (One to two page giving information to understand the rationale for the trial, its objectives and the methods) Study Rationale: Study Rationale why study should be done. (Priority areas regarding the need, lacunae in existing knowledge. Granting agencies have priority areas. Explain how you study fits into those areas. ) Ask: 1. Will this study generate new knowledge? 2. Will the study benefit patients, society, helps in advance understanding or influence policy, ? 3. Will the study fill gaps in existing knowledge or resolve current controversies? (Ideally a study should do more than just generate new knowledge) Who Writes the Protocol?: Who Writes the Protocol? Investigators and study team Sponsor Commercial manufacturer Pharmaceutical or Biotech company Medical Device company BACKGROUND INFORMATION: BACKGROUND INFORMATION Justifies why the study is considered scientifically worthwhile Requires a detailed literature search Helps to select studies that have potential significance Helps to identify deficiencies in the literature and ways to address them STUDY AIMS / OBJECTIVES: STUDY AIMS / OBJECTIVES Concise statements of the major and minor questions that the study is designed to answer. May have primary and secondary objectives. No more than 1 or 2 of each should be included in a research study. (Remember- Aims and Objectives are different) Methodology : Methodology Sample size Sample size calculation is recommeded for scientific, economical and ethical reasons Level of significance, Power of the study and expected impact of exposure on outcome. Better to take the help of Statistician Inclusion and Exclusion criteria- Randomization- Blinding- STUDY DESIGN: STUDY DESIGN Study designs many types:- Double blind Double dummy Case control Nested case control Cohort Cross-sectional Parallel Crossover Others Intervention/Observations/ Data Collection: Intervention/Observations/ Data Collection Intervention / Investigation - Surgical/medical or both Mode - Duration - Observations recording s – Analysis of Data- Statistical tests Appendices : Appendices Summary of Product Characteristics Measurement tools and their validation Pharmacy information such as dosage tables and information on reconstitution, storage information, shelf lives Methods for collecting patient samples, their storage, dispatch and handling conditions Clinical labs and tests Adverse reaction recording and grading systems Scoring systems of efficacy parameters Analysis diagram Declaration of Helsinki Patient and parent/legal guardian consent form Subject information sheet for informed consent Method of recruitment of patients/subjects to the study Ethical considerations: Ethical considerations Important aspects to consider: Data safety / confidentiality Any possibility of harm/ side effects/ consequences Right of discontinuation at any time Alternative treatments/ approaches Incentives/ Rewards Insurance of the subject One of the most important aspects of biomedical research ! Ask ethics committee for advice and clearance! Work plan: Work plan Who? Tasks When? Where? Budget: Budget Items Personnel Consumables Equipment, Expeniture in data processing Funds for patients Communication and Travel Miscellaneous Budget justification Jusitify the use of each item, person considering the workplan of the study References/Bibliography: References/Bibliography Referencing is important and indicates the sources of information, ideas. This also increases the credibility of the statements. If the authors are more than 6 then only the first three followed by et al. Standard referencing systems: Harvard style (Name and Year or APA [American Psychological Association]) Name and publication year in text eg. Kumar and Kumar (2008) Alphabetical bibliography eg. Muller, V. (1994) ‘Trapped in the body’,  The Australian Law Journal , vol. 3, August, pp. 103-107. Vancouver style (ICMJE [International Committee of Medical Journal Editors] Developed by US National Library of Medicine [NLM]) Numbered references eg. In bracket text (10) or superscript text eg. 10 Continous referencing in numbers. eg.10. Reddy MS, Srinivas s, Sabanayagam N. Accuracy of references in general surgical journal-An old problem revisited. Surgeon 2008;6:71-5 Important reference for the reference writing- uniform Requirements for manuscripts submitted to biomedical journal. International Committee of Medical Journal Editors, American College of Physicians, 2008. http://www.icmje.org How to judge a good protocol?: How to judge a good protocol? Is it adequate to answer the research question(s), and achieve the study objectives? Is it feasible in the particular set-up for the study? Does it provide enough detail (methodology) that can allow another investigator to do the study and arrive at comparable conclusions? Analyzing a Protocol: Analyzing a Protocol What? Why? Who? Where? When? How? KEYS TO SUCCESS TO WRITE A GOOD PROPOSAL : KEYS TO SUCCESS TO WRITE A GOOD PROPOSAL Clear , Concise and scientific based research question Informative title Self-sufficient and convincing abstract Sufficient background and rationale Appropriate research design Appropriate, Detailed and feasible methodology Appropriate population (or animals) and sample size Appropriate measurement and intervention methods Appropriate Place of work Appropriate Quality control Qualified research team Appropriate data collection/analysis – (Help from statistician prior to writing) Ethical issues well addressed Tight and rational budget Realistic timetable Identify strengths and limitations Written without typographical errors Incomplete / Wrong Protocol Leads to-: Incomplete / Wrong Protocol Leads to- Protocol non-compliance Poor decision making in Subject Safety Study Conclusions Regulatory objections including no clearance from ethics committee Budget deficits A protocols that go nowhere Common Protocol Deviations: Common Protocol Deviations Non-adherence to inclusion/exclusion criteria Failure to comply with dispensing and dosing requirements Incorrect storage of study medications Use of prohibited concomitant medications Failure to follow subject termination plan Failure to report adverse events Failure to follow statistical plan Failure to amend protocol and obtain IRB approval prior to implementing changes Failure to document and report deviations Common problems: Common problems Insufficient attention to previous literature Poor justification why is it important to answer this question? what impact does it have on public health? Poorly formulated objectives! Unspecific. Inadequate description Inappropriate analytical strategies Inadequate budget Too ambitious: too many questions BEFORE YOU START : BEFORE YOU START Developing a research proposal takes time. The process starts by identifying A general area or research and then Developing a focused research question to be answered. Extensive Discussion, Suggestions from the experts Drafting the first draft Modifications as suggested Final Draft to be submitted (Read over the guidelines (length, structure and format of the proposal) and deadlines of agency. (10 Oct. 2014) (The probability of success of a research project is greatly enhanced when the “beginning” is correct) Thank you for your kind attention!: Thank you for your kind attention!

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