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Introduction to clinical research

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  • Research in doable, possible even in our daily busy working life
  • That affect individuals, communities or the health systemAllow systematic and scientific assessment or evaluation or problemsOften provide information/knowledge that allow change to occur
  • Who design a protocol sponsor/ medical expertiseInvestigator (IIR)
  • The NMRR is the web based tool designed to support the implementation of the National Institute of Health NIH guideline on the conduct of research in the Ministry of Health Malaysia (MOH)
  • Transcript

    • 1. An introduction of: Investigator initiated research (IIR) DR NOR HIDAYAH ZAINOOL ABIDIN Department of Anaesthesiology and Critical care HRPZ 2, Kota Bharu
    • 2. What is research? • A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalize knowledge
    • 3. Research is best learnt by actually conducting the research project rather than reading or attending lecture
    • 4. Simple study base on questionnaire • KNOWLEDGE, ATTITUDE, AND PRACTICE (KAP) STUDY OF DENGUE AND CHIKUNGUNYA DISEASE AMONGST ADULT POPULATION OF KAMPUNG TANJUNG API, KUANTAN, PAHANG, 2009
    • 5. Why research? – The right mindset! • • • • • • • • Untuk mengambil hati boss. Untuk mendapat markah SKT yang tinggi. Untuk naik pangkat. Untuk orang ramai kenal saya. Untuk menang dalam pertandingan. Untuk mengisi masa lapang. Dipaksa/ Dipaksarela. Saya nak belajar lebih
    • 6. Data is power…… • Vital to the understanding of problems • • • • • • • • Translate basic sciences to human studies, and subsequently to clinical practices. New drug/ technology development New diagnostic techniques To compare effectiveness To compare safety profile To study the healthcare systems Economic evaluation Applied research
    • 7. Research impact • Build the scientific foundation for clinical practice • Prevent disease and disability • Manage and eliminate symptoms caused by illness • Enhance end-of-life and palliative care • To help the decision making processes
    • 8. Examples of Clinical Research Types • Clinical trials or therapeutic research Clinical epidemiology: disease diagnosis and prognosis, clinical decision making • Clinical Economics; cost-effectiveness of healthcare • Disease epidemiology: incidence, prevalence, distribution of and risk factors for disease X
    • 9. What is Clinical trial/clinical study? • It is any investigation in human subject intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigation product(s), with the object ascertaining its safety and/or efficacy
    • 10. General type of research • Commercialized (ISR – industry sponsored research) – Pharmaceutical companies provide protocol and funds for the researcher to recruit patients and implement the study • Non-commercialized (IIR – investigator initiated reasearch) – Investigator initiates clinical trials with or without the involvement of the drug companies
    • 11. Why should we be involve in clinical trials? • Reinforcement or our clinical practice – Clinical trial does not differ much with daily practice apart from following protocols stringently – Application of research findings • Continuous medical education (CME) – Well verse with the topic/areas involve in the trial • A lot more readings, literiture search and discussion with expert of the area
    • 12. • Advantages to clinician/ investigators • Benefits to patients • Advantages to the institutions • Advantages to pharmaceutical companies • Benefits to the country Advantages of doing clinical trials
    • 13. Advantages to the clinician/investigator • • • • • • Extra money Travel overseas Academic achievement Experience in well planned clinical trial Practice better medicine Experience working with experienced clinician and peer recognition • Experience with pre release drugs
    • 14. Benefits to the patient • Better monitoring of patient’s medical problems • Managed by most experienced and dedicated people • Better relationship with physician resulting in better outcome of medical problem
    • 15. Disadvantages in clinical trials • Clinician/investigators – Time consuming – Extended commitment • Patient – Risk of developing side effects – Sereious Adverse event & adverse reaction • Pharmaceutical companies – Risk of great financial loss if outcome of trial not favour them
    • 16. Requirement to become investigators • Clinician • GCP certified • Ready to give full commitment to make it successful
    • 17. What is Good clinical practice (GCP)? • A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of the clinical trials that provide assurance that the data and the reported results are credible, and accurate, and the rights, integrity and confidentiality of the trial subjects are protected
    • 18. GCP- provisions and prerequisites for a clinical trial • • • • • Ethical principle Declaration of Helsinki Justice Respect for person Beneficience (maximize benefits and minimize harms and wrongs) • Non maleficence (do no harm) • Fully informed
    • 19. Ethical principles & requirements • Safeguards the rights, safety and well being of all trial subjects – Trial protocol/ amendments – Written informed consent – Subject recruitment procedures – Written informations to be provided to subject
    • 20. PATIENT INFORMATION SHEET AND INFORMED CONSENT FORM 1. 2. 3. 4. Title of study: Name of investigator and institution: Name of sponsor: Introduction: 1. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. You are invited to participate in a research study (brief introduction why they are selected and what the study is all about) What is the purpose of the study What kind of study products will I receive What will happen if I decide to take part? (need to fill up medical history data, or questionnaire, or follow the treatment schedule (just a give a brief what patient need to do, can be in numbering or phrases form.) What are my responsibilities when taking part in this study? What kind of treatment will I receive after my participation in the trial? What are the potential risks and side effects of being in this study? What are the benefits of being in this study? Who is funding the research Can the research or my participation be terminated early Will my medical information be kept private Who should I call if I have questions
    • 21. Protocol • A document that prescribes the – – – – – – objectives design methodology statistical considerations organisation of trial background and rationale for the trial • Throughout the ICH-GCP guideline the term protocol refers to protocol and protocol amendments (a written description of changes to or formal clarification of a protocol
    • 22. • • • • • • • Generate ideas Review related literatures Formulate research questions/ objectives Design research & study proposal Conduct study Analyse data Interpret results Determine implications of research (conclusion and recommendations) • Publication/ presentation
    • 23. Complicated????
    • 24. CRC Malaysia
    • 25. • Perkhidmatan • Pengenalpastian pesakit • Pemilihan subjek • Pegurusan projek – Registry pesakit – Menjalinkan usahasama dalam kajian • Kursus dan latihan – Program bimbingan • • • • • • Pendaftaran dan permohonan geran penyelidikan Pembentukan protocol kajian Analisa statistik Pembentangan hasil kajian Penulisan saintifik hasil penyelidikan Analisa statistik – Pembentangan GCP • Khidmat rundingan – Pendaftaran penyelidikan – Rekabentuk dan metodology kajian
    • 26. CRM
    • 27. Research in Ministry of health (MOH) Current MOH policy on research, as specified in the guideline, requirement
    • 28. Policy statement 1 • All research require prior registration with the approval by MOH • National medical research registry (NMRR) • To upload – Agreement from investigators – Agreement of HOD – Agreement of director of institutions/hospital • NIH review and approval
    • 29. Policy statement 2 • Research involving human subjects require prior review and approval by the medical research @ ethical committee (MREC)
    • 30. Policy statement 3 • All research publications and presentations must have DG of health approval • Submit cover letter + form + draft to NIH secreteriats • Prior review by NIH panels • NIH sec  DDG (P&ST)  DG
    • 31. National Medical Research Register (NMRR) The NMRR is thus specifically designed to enable: • Online registration of research. to be registered in publicly accessible research registers. • This is to ensure transparency and to increase public trust in the conduct of medical research; as well as to inform physicians and prospective volunteers about ongoing research in which they may wish to enroll. • Online submission to an appropriate authority for approval, as well as online review of the submitted research by relevant appointed reviewers. The online system ought to reduce the research review time as well as to enable investigators to track the status of their research online • Online submission of research publication to the NIH for approval • Finally, the NMRR also enable MOH management to document the level of research activity in the MOH, and also to track the progress of the research it has approved and/or provided support such as funding. • The title of all registered research and its associated publications where available will be published in the Directory of Medical Research on the NMRR website. • In the process of registering a research, participating investigators are required to be registered on NMRR too. All such registered investigators shall also be published in a Directory of Clinical Investigator & Medical Researchers on the NMRR website. The Directory should be of help to investigators to locate other potential collaborators, and to sponsor of clinical trial to identify suitably qualified clinical investigators to participate in their multi-centre trials.
    • 32. Documents for submission • Research documents – – – – Protocol synopsis Protocols/ amendments Investigator broshure Patient informed consent • Investigators documents – – – – CVs GCP certificate Investigator’s agreement and HOD approval Professional indemnities
    • 33. Research tools • to create dataset and data analysis – SPSS – Epi-info • Endnote – Search, organize and share research. And automatically format bibliographies with the only patented bibliography technology. • Epical 2000 software – statistical calculator that works with pretabulated data
    • 34. Because bunches and guesswork is not enough