Clinical Neuroscience - Clinical Trials

Wichtige Krankheitsbilder der Neurowissenschaften - Clincial Trials

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Flashcards	22
Language	English
Category	Medical
Level	University
Created / Updated	25.05.2014 / 16.01.2024
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Quality Mangament of Clinical Trial Center (CTC). What are the important subgroups of organization?

Regulatory Affairs

Monitoring

Data Management & IT-Coordination

Project Management (Trial Unit and Phase-1-unit)

ITT

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Regulatory Affairs

Monitoring

Data Management & IT-Coordination

Project Management (Trial Unit and Phase-1-unit)

ITT

Trials performed at the CTC. There is no difference between sponsored clinical research and investigator initiated research (ITT). ITT means investigator initiated trials which are performed with industry support (= sponsored trials).
Which trials are performed?

ITT and NCT (non-commercial trials)

epidemiological and observation trials

trials for medical devices

clinical trials in other areas (e.g. surgery)

drugs

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ITT and NCT (non-commercial trials)

epidemiological and observation trials

trials for medical devices

clinical trials in other areas (e.g. surgery)

drugs

PHASE 1 = safety and toxicity.
The important questions adressed are: is dosage safe? How should drug be administered? How is the body affected?

tolerability

metabolism

healthy volunteers

10-50 participants

always symptomatic healthy volunteers

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tolerability

metabolism

healthy volunteers

10-50 participants

always symptomatic healthy volunteers

PHASE II = therapeutic explorative. The important questions adressed are: Is the treatment working and how is the body affected?

proof of concept

dose optimizing

side effects

50-200 participants

there is no control group

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proof of concept

dose optimizing

side effects

50-200 participants

there is no control group

PHASE III = therapeutic confirmative. The most important question wich is addressed: Risk vs. benefit?

efficacy

statistic significant group: 200-1000 participants

dose optimizing

control group

it is not trying to imitate real conditions

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efficacy

statistic significant group: 200-1000 participants

dose optimizing

control group

it is not trying to imitate real conditions

PHASE IV = post marketing authorisation

first: approval by health authorities is required

long-term safety has to be assured

short-term safety has to be assured

focus is on effectivness

subgroup

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first: approval by health authorities is required

long-term safety has to be assured

short-term safety has to be assured

focus is on effectivness

subgroup

Which are the types of clinical trials?

Treatment & Prevention

Screening & Diagnostics

Genetics

Quality-of-life / supportive care

Palliative care

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Treatment & Prevention

Screening & Diagnostics

Genetics

Quality-of-life / supportive care

Palliative care

Pre-Clinical development is the first stage in drug development. Which is true about it?

takes 3-4 years

one part: selection

one part: pre-clinic

takes 4-5 years

use in galenics, pharmacology and toxicology

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takes 3-4 years

one part: selection

one part: pre-clinic

takes 4-5 years

use in galenics, pharmacology and toxicology

Clinical development is the middle stage in drug development. Which is true about it?

divided into phase I, II and III

regulatory process is a part of clinical development

takes approx. 6 years

takes approx. 2-3 years

used for pathology

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divided into phase I, II and III

regulatory process is a part of clinical development

takes approx. 6 years

takes approx. 2-3 years

used for pathology

Which is the correlation between study phases and study types?

phase IV: Therapeutic application

phase III: Therapeutic confirmative

phase II: Therapeutic explorative

phase I: Human pharmacology

phase IV: Human pharmacology

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phase IV: Therapeutic application

phase III: Therapeutic confirmative

phase II: Therapeutic explorative

phase I: Human pharmacology

phase IV: Human pharmacology

Which are the main regulators in the USA?

FDA - Food and Drug Administration (US)

CDER - Center for Drug Evaluation and Research (US)

EMA - European Agency for the Evaluation of Medicinal Products

CPMP - Committee for Proprietary Medicinal Products

IBT

FDA - Food and Drug Administration (US)

CDER - Center for Drug Evaluation and Research (US)

EMA - European Agency for the Evaluation of Medicinal Products

CPMP - Committee for Proprietary Medicinal Products

IBT

Swiss regulations are managed by Swissmedic. The corresponding regulatory artwork is the HRA. What is true?

HRA = Human Research Act

Clinical Trial = health-related intervention (KlinV)

Non-clinical trial = personal data / biological material (HFV)

Risk categorization: C (high risk) - A (low risk)

Risk categorization: A (high risk) - C (low risk)

HRA = Human Research Act

Clinical Trial = health-related intervention (KlinV)

Non-clinical trial = personal data / biological material (HFV)

Risk categorization: C (high risk) - A (low risk)

Risk categorization: A (high risk) - C (low risk)

Risk based categorization of drugs and transplantation products?

categorie A: swissmedic approval required, prescribing information and deviation from it

categorie B: swissmedic approval required, deviation outside prescribing is possible

categorie C: no swissmedic approval needed

categorie A: no swissmedic approval required, prescribing information and deviation from it

categorie C: swissmedic approval needed

categorie A: swissmedic approval required, prescribing information and deviation from it

categorie B: swissmedic approval required, deviation outside prescribing is possible

categorie C: no swissmedic approval needed

categorie A: no swissmedic approval required, prescribing information and deviation from it

categorie C: swissmedic approval needed

Regulatory consequences of drugs and transplantation products?

A: Approval of Ethical Committee, Simplified Submission and Reporting Document, reduced indemnification obligation

B: Approval of Ethical Committee, Simplified Submission and Reporting Document

C: Approval by Ethical Committee and Swissmedic

C: No Approval by Ethical Committee and Swissmedic

A: Approval of Ethical Committee, Simplified Submission and Reporting Document, reduced indemnification obligation

B: Approval of Ethical Committee, Simplified Submission and Reporting Document

C: Approval by Ethical Committee and Swissmedic

C: No Approval by Ethical Committee and Swissmedic

Summary of regulations?

All research on humans must be regulated

Facilitations by risk categorization possible

Parallel application to Ethics Committee & Swissmedic saves time

Central registration of clinical trials

No Central registration of clinical trials

All research on humans must be regulated

Facilitations by risk categorization possible

Parallel application to Ethics Committee & Swissmedic saves time

Central registration of clinical trials

No Central registration of clinical trials

ICH - International Conference on Harmonization

working groups of pharmacutical industry experts and regulatory authorities (US, EU and Japan)

quality = Stability & Impurity Testing

ICH - goals: safety, quality and efficacy

safety = Carcinogenicity & Genotoxicity Testing

efficacy = Dose Response Studies & Good Clinical Practice

working groups of pharmacutical industry experts and regulatory authorities (US, EU and Japan)

quality = Stability & Impurity Testing

ICH - goals: safety, quality and efficacy

safety = Carcinogenicity & Genotoxicity Testing

efficacy = Dose Response Studies & Good Clinical Practice

GCP - good clinical practice - is an international ethical and scientific quality
standard for?

designing

conducting

recording

reporting

registration

designing

conducting

recording

reporting

registration

GCP Design Standards?

Protocol and Investigator’s Brochure content

Project is scientifically sound and feasible

Adequate resources (research personell)

Randomization / blinding procedures

Compliances with protocol

Protocol and Investigator’s Brochure content

Project is scientifically sound and feasible

Adequate resources (research personell)

Randomization / blinding procedures

Compliances with protocol

GCP Conduct Standards?

Regulatory + ethics committee approvals

Compliances with protocol

Informed consent / confidentiality

Medical Management / adverse event recording

Qualifications + Training

Regulatory + ethics committee approvals

Compliances with protocol

Informed consent / confidentiality

Medical Management / adverse event recording

Qualifications + Training

GCP Recording Standards?

Case Report Form completion

Data handling (data management)

Security / audit trails

Product accountability (drug count)

Study Files / essential documents

Case Report Form completion

Data handling (data management)

Security / audit trails

Product accountability (drug count)

Study Files / essential documents

GCP Reporting Standards?

Safety reporting (serious adverse events)

Progress reports

Monitoring reports / audit reports

Clinical trial report

Data handling (data management)

Safety reporting (serious adverse events)

Progress reports

Monitoring reports / audit reports

Clinical trial report

Data handling (data management)

Why GCP?

Dr. Massengill‘s Elixir - solvent was Diethylene-Glycol (1937)

Misuse of clinical research in Germany before and during 2nd world war

Tuskegee Study - Syphilis study: misinformation and restriction of treatment

Thalidomide Tragedy - caused birth defects (deformities) at approx. 5‘000 – 10‘000 children

Ketek-Study 3014 - Sanofi-Study with major and critical deficiencies & Incontinence Study, 2008

Dr. Massengill‘s Elixir - solvent was Diethylene-Glycol (1937)

Misuse of clinical research in Germany before and during 2nd world war

Tuskegee Study - Syphilis study: misinformation and restriction of treatment

Thalidomide Tragedy - caused birth defects (deformities) at approx. 5‘000 – 10‘000 children

Ketek-Study 3014 - Sanofi-Study with major and critical deficiencies & Incontinence Study, 2008

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