{"id":null,"code":"DRUG0011","name":{"valueFi":"Clinical Trial Design and Clinical Drug Research","valueEn":"Clinical Trial Design and Clinical Drug Research","valueSv":"Clinical Trial Design and Clinical Drug Research"},"credits":5.0,"minCredits":5,"maxCredits":5,"tags":[],"createdAt":1790534697726,"contentList":[{"title":{"valueFi":"Osaamistavoitteet","valueEn":"Learning outcomes","valueSv":""},"content":{"valueFi":"After passing the study module, the student: \r\n- Understands the phases and flow of clinical drug development studies\r\n- Identifies relevant restrictions and error sources in clinical drug studies \r\n- Can evaluate ethical aspects of a clinical drug trial \r\n- Knows the principles of GCP and the central legislation and regulatory guidance for clinical drug research \r\n- Understands the tasks of different professional groups in the efficient and safe implementation of a clinical drug study \r\n- Is able to compile a protocol for a clinical drug trial \r\n- Understands the basics of statistical analysis applicable in clinical trials\r\n- Can critically interpret publications on clinical drug trials.","valueEn":"During the course the student is offered an opportunity to learn all the basic skills needed to plan and execute a clinical drug trial. After passing the study module, the student: \r\n- Understands the phases and flow of clinical drug development studies\r\n- Identifies relevant restrictions and error sources in clinical drug studies \r\n- Can evaluate ethical aspects of a clinical drug trial \r\n- Knows the principles of GCP and the central legislation and regulatory guidance for clinical drug research \r\n- Understands the tasks of different professional groups in the efficient and safe implementation of a clinical drug study \r\n- Is able to compile a protocol for a clinical drug trial \r\n- Understands the basics of statistical analysis applicable in clinical trials\r\n- Can critically interpret publications on clinical drug trials.","valueSv":"After passing the study module, the student: \r\n- Understands the phases and flow of clinical drug development studies\r\n- Identifies relevant restrictions and error sources in clinical drug studies \r\n- Can evaluate ethical aspects of a clinical drug trial \r\n- Knows the principles of GCP and the central legislation and regulatory guidance for clinical drug research \r\n- Understands the tasks of different professional groups in the efficient and safe implementation of a clinical drug study \r\n- Is able to compile a protocol for a clinical drug trial \r\n- Understands the basics of statistical analysis applicable in clinical trials\r\n- Can critically interpret publications on clinical drug trials."}},{"title":{"valueFi":"Sisältö","valueEn":"Content","valueSv":""},"content":{"valueFi":"- Phases and types of clinical drug trials.\r\n- Properties of a compound investigated before authorization of a new drug.\r\n- Ethical and regulatory evaluation of clinical trials.\r\n- GCP, regulations and legislation regarding clinical drug research. \r\n- Data collection and management in clinical drug trials.\r\n- Composition of a clinical drug trial protocol.\r\n- Monitoring and auditing of clinical trials.\r\n- Statistical planning.\r\n - Reporting and interpretation of results.","valueEn":"- Phases and types of clinical drug trials.\r\n- Properties of a compound investigated before authorization of a new drug.\r\n- Ethical and regulatory evaluation of clinical trials.\r\n- GCP, regulations and legislation regarding clinical drug research. \r\n- Data collection and management in clinical drug trials.\r\n- Composition of a clinical drug trial protocol.\r\n- Monitoring and auditing of clinical trials.\r\n- Statistical planning.\r\n- Reporting and interpretation of results.","valueSv":"- Phases and types of clinical drug trials.\r\n- Properties of a compound investigated before authorization of a new drug.\r\n- Ethical and regulatory evaluation of clinical trials.\r\n- GCP, regulations and legislation regarding clinical drug research. \r\n- Data collection and management in clinical drug trials.\r\n- Composition of a clinical drug trial protocol.\r\n- Monitoring and auditing of clinical trials.\r\n- Statistical planning.\r\n - Reporting and interpretation of results."}},{"title":{"valueFi":"Suoritustavat","valueEn":"Study methods","valueSv":""},"content":{"valueFi":"Active participation in lectures by experts from academia, authorities and pharmaceutical industry. \r\nParticipation in hands-on demonstrations on basic statistical principles and methodology applied to clinical drug trials.\r\nParticipation in Journal Clubs (mandatory).\r\nCompilation of a clinical trial protocol in small groups and participation in a feedback session (mandatory).\r\nAccepted completion of a written examination.","valueEn":"Active participation in lectures by experts from academia, authorities and pharmaceutical industry. \r\nParticipation in hands-on demonstrations on basic statistical principles and methodology applied to clinical drug trials.\r\nParticipation in Journal Clubs (mandatory).\r\nCompilation of a clinical trial protocol in small groups and participation in a feedback session (mandatory).\r\nAccepted completion of a written examination.","valueSv":""}},{"title":{"valueFi":"Toteutustavat","valueEn":"Course unit methods","valueSv":""},"content":{"valueFi":"The course is composed of\r\n- Lectures given by experts working either in academia or industry (22 h)\r\n- Biostatistics demonstrations (8 h)\r\n- Journal clubs (8 h)\r\n- Practical work: Compilation of a GCP-compliant research protocol for a clinical drug trial in small groups (55 h)\r\n- A feedback session about the research protocol (2 h)\r\n- A written examination","valueEn":"The course is composed of\r\n- Lectures given by experts working either in academia or industry (22 h)\r\n- Biostatistics demonstrations (8 h)\r\n- Journal clubs (8 h)\r\n- Practical work: Compilation of a GCP-compliant research protocol for a clinical drug trial in small groups (55 h)\r\n- A feedback session about the research protocol (2 h)\r\n- A written examination","valueSv":""}},{"title":{"valueFi":"Oppimateriaalit","valueEn":"Learning material","valueSv":""},"content":{"valueFi":"Lecture materials, study materials for Biostatistics demonstrations and Journal Clubs, relevant regulatory guidance and legislation. All study materials are provided during the course.","valueEn":"Lecture materials, study materials for Biostatistics demonstrations and Journal Clubs, relevant regulatory guidance and legislation. All study materials are provided during the course.","valueSv":""}},{"title":{"valueFi":"Lisätiedot","valueEn":"Further information","valueSv":""},"content":{"valueFi":"Quota for minor studies students is 1-5.","valueEn":"Quota for minor studies students is 1-5.","valueSv":""}},{"title":{"valueFi":"Kurssikirjallisuus","valueEn":"Literature","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Esitietovaatimukset","valueEn":"Qualifications","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Arviointiasteikko","valueEn":"Assessment scale","valueSv":""},"content":{"valueFi":"0-5","valueEn":"0-5","valueSv":"0-5"}},{"title":{"valueFi":"Arviointikriteerit","valueEn":"Assessment criteria","valueSv":""},"content":{"valueFi":"Exam 0-5. Clinical trial Protocol: Pass/Fail. An excellent Clinical trial protocol (group work) can raise the final grade of the course by +1 (counting from the individual exam grade) for all the group members.","valueEn":"Exam 0-5. Clinical trial Protocol: Pass/Fail. An excellent Clinical trial protocol (group work) can raise the final grade of the course by +1 (counting from the individual exam grade) for all the group members.","valueSv":""}},{"title":{"valueFi":"Arviointikriteerit 2","valueEn":"Assessment criteria 2","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Arviointikriteerit 3","valueEn":"Assessment criteria 3","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Arviointikriteerit 4","valueEn":"Assessment criteria 4","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Kielet","valueEn":"Languages","valueSv":""},"content":{"valueFi":"englanti","valueEn":"English","valueSv":"engelska"}},{"title":{"valueFi":"Taso","valueEn":"Level","valueSv":""},"content":{"valueFi":"Syventävät opinnot","valueEn":"Advanced Studies","valueSv":""}},{"title":{"valueFi":"Oppiaine","valueEn":"Subject","valueSv":""},"content":{"valueFi":"Drug Discovery and Development","valueEn":"Drug Discovery and Development","valueSv":"Drug Discovery and Development"}},{"title":{"valueFi":"Vastuuhenkilöt","valueEn":"Person in charge","valueSv":""},"content":{"valueFi":"Päivi Hirvensalo","valueEn":"Päivi Hirvensalo","valueSv":"Päivi Hirvensalo"}},{"title":{"valueFi":"Luokittelu","valueEn":"Classification","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Linkit","valueEn":"Links","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}}]}