Research protocols Good clinical practice Research funding. Research protocols Good clinical practice Research funding
Research protocols Good clinical practice Research funding PhD Ane Johannessen Kompetansesenter for klinisk forskning
Research protocols Good clinica...
Research protocols Good clinical practice Research funding PhD Ane Johannessen Kompetansesenter for klinisk forskning
Research protocols Good clinical practice Research funding
Conducting a study with a research protocol
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Conducting a study without a research protocol
The aim of a research protocol To give a clear description of a planned study
1. Facilitates planning 2. Helps accomplishing the study 3. Is a tool for evaluating the study after it has been completed
The aim of a research protocol 1. Facilitates planning Writing the protocol forces the researcher to clarify his/her thoughts and to think about all aspects of the study Writing the protocol stimulates cooperation
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The aim of a research protocol 2. Helps accomplishing the study The protocol is the ”user manual” The protocol is essential when applying for research funding
The aim of a research protocol 3. Is a tool for evaluating the study after it has been completed
- Discrepancies between protocol and study - Comparable results if repeated
The contents of a research protocol 9 The more in-depth the protocol is, the easier it is to complete the research project
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The contents of a research protocol 9 Introduction 9 Material and methods 9 Time schedule 9 Ethical considerations 9 Relevant literature / publication plan 9 Budget
The contents of a research protocol Title Summary 9 Introduction 9 Material and methods Participants 9 Time schedule Background 9 Ethical considerations Aims 9 Relevant literature / publication plan 9 Budget
The contents of a research protocol Study population
9 Introduction Design 9 Material and methods Statistics 9 Time schedule 9 Ethical considerations 9 Relevant literature / publication plan 9 Budget
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The contents of a research protocol
Training phase
Finishing date 9 Introduction 9 Material and methods Milestone dates 9 Time schedule Data management 9 Ethical considerations Delays 9 Relevant literature / publication plan 9 Budget
The contents of a research protocol 9 Introduction 9 Material and methods Approval 9 Time schedule Informed consent 9 Ethical considerations Checklist 9 Relevant literature / publication plan 9 Budget
The contents of a research protocol 9 Introduction Existing literature 9 Material and methods Planned papers 9 Time schedule List of authors 9 Ethical considerations 9 Relevant literature / publication plan 9 Budget
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The contents of a research protocol 9 Introduction 9 Material and methods 9 Time schedule 9 Ethical considerations Costs 9 Relevant literature / publication plan Insurance 9 Budget Sponsors
Pre-testing the protocol – pilot study 9 Testing the recruitment plan 9 Testing the methods of measurement 9 Testing for inter- and intra- observer reliability 9 Testing the system for data mangement
Key words for writing a highquality research protocol 9 Careful planning, no haste 9 Accurate and concise language 9 Direct involvement in all parts of the study
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Research protocols Good clinical practice Research funding
Good clinical practice (GCP) 9 Clinical trialsÆ drug regulatory authorities Æ approved for general use 9 Both results and process are reviewed 9 Research must conform to GCP guidelines
What is good clinical practice? 9 GCP is ”a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected”.
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The history of GCP 9 ICH = The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 9 Europe, the US and Japan 9 Recommendations to avoid need for duplicate testing during development of new medicines
Official GCP regulations 9 Norwegian regulation for clinical trials 1. May 2004 9 Revised according to EU directive 2001/20/EC 9 Aim of the European GCP directive: to ensure common legislation on clinical trials in all member-states
Norwegian GCP regulations 9 Application for clinical trial 9 Assessment of the trial 9 Protection of privacy 9 Investigator’s qualifications 9 Requirements relating to the trial 9 Supervision and suspension
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Application for clinical trial 9 Official application form 9 Protocol 9 Supplementary information about the trial 9 Documentation of the medicinal product 9 Notification to the ethics committee 9 Information for the participants 9 Confirmation of paid fee
Assessment of the trial 9 Overall assessment of the trial 9 One revision only 9 Assessment 60 days after submitting an application
Protection of privacy 9 Requirement of informed consent 9 Clinical trials on minors 9 Clinical trials on persons unable to give informed consent 9 The right to withdraw a consent 9 Duty of confidentiality
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Investigator’s qualifications 9 Conduct the clinical trial 9 Appropriate use of the medicinal products 9 Comply with GCP 9 Permit monitoring, auditing and inspection 9 Maintain list of qualified persons
Requirements relating to the trial 9 Protocol and source data 9 Labelling and dispensing of medicinal product 9 Notification duties 9 Reports
Supervision and suspension 9 Supervisory authority 9 Inspection 9 Suspension of clinical trials
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Essential GCP principles 9 Clinical trials should be conducted according to the Helsinki declaration 9 The rights, safety and well-being of the trial subjects should prevail over interests of science and society 9 Each individual involved in a trial should be qualified by education, training and experience
Useful GCP links 9 Guidelines for GCP by EMEA: www.emea.europa.eu/pdfs/human/ich/013595en.pdf
Research protocols Good clinical practice Research funding
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Overview types of grants 9 Personal grants 9 General / group grants 9 Postdoc grants 9 Short-term grants 9 Equipment grants 9 Travel grants 9 Grants for research stays abroad
Overview resources for funding 9 International 9 National 9 Regional 9 Local
Overview resources for funding EU FP7
9 International 9 National 9 Regional 9 Local
International cooperation National Institute of Health
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Overview resources for funding 9 International 9 National 9 Regional 9 Local
NFR Health and Rehabilitation Special interest organisations
Overview resources for funding 9 International 9 National 9 Regional 9 Local
Universities
Helse Vest / Samarbeidsorganet
Overview resources for funding 9 International 9 National 9 Regional 9 Local
Hospitals
Institutes
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Results from Samarbeidsorganet 2010 2010
2009
2008
Doktorgradsstipend
Søknadstype
86
87
100
Korttidsprosjekt
29
37
23
Korttidsstip, for fullføring av dr. grad
17
16
16
Kun søknad om utenlandsstipend
3
8
6
Nytt flerårig forskningsprosjekt
85
100
90
Postdoktorstipend
37
41
32
Videreførte flerårige prosjekter
42
47
45
Totalt
299
336
318
Evaluation of applications 9 Quality criterion - assessment of the scientific quality of the applicant, the project and the research environment 9 Criterion of relevance - assessment of relevance according to highpriority research areas and cooperation
Useful hints for application writing 9 Write so that persons outside your field of research can understand you 9 Clear, direct and concise language 9 It must be very clear and straightforward to the reader that the application includes background, aims, methods, and strategies to accomplish the project
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Useful hints for application writing 9 Be thorough in specifying income and costs in the budget 9 Create a realistic budget with room for small unforeseen changes 9 Limit the amount of PCs and unspecified travel costs in the budget
Useful hints for application writing 9 It should be specified how far the PhD candidate has come in his/her work at the time of application 9 It should be obvious to the reader that the applicant is aware of everything that could go wrong in the project 9 The reader must truly believe that the only thing that is missing for this project to become a success is funding
