ICH Guidance Impacting Clinical Trials

A 2-minute survey to check your awareness of a November 2019 ICH Guidance impacting the design, analysis, conduct, and reporting on clinical trials.

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* 1. What is the type of Company you work for?

Pharmaceutical or Biotechnology

Contract Research Organization

Regulatory Agency

Academia

Medical Device

Investigation Site

Consultant

Other (please specify)

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* 2. What is your primary area of expertise?

Clinical

Monitoring

Project Management

Medical

Regulatory

Data Management

Biostatistics

Medical Writing

Programming

Pharmacovigilance

Sr/Executive Management (CEO/CFO/CIO/CxO)

Other (please specify)

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* 3. How many years have you been involved in Clinical Research?

<10 years

10 to <20 years

20 to <30 years

30 or more years

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* 4. Are you familiar with clinical trial endpoints?

Yes

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* 5. Do you feel missing data in clinical trials may make interpretation of results difficult?

Yes

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* 6. Are you aware of the 1998 ICH E9 guidance on Statistical Principles for Clinical Trials?

Yes

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* 7. Did you know a final addendum ICH E9 R1 was issued to this guidance on Estimands and sensitivity analyses on 20 Nov 2019?

Yes

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* 8. Have you applied the concept of Estimands in designing your clinical trials?

Yes

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* 9. What sources do you use to keep up with current regulatory requirements for clinical trials?

Internal Regulatory Group

Internal Group with Functional Expertise (e.g. Biostatistics)

Journals (Indicate Journals under Other below)

Online Sources (Indicate Online Sources under Other below)

Emails from FDA or Other Organizations (indicate details under "Other" below)

Other (please specify)

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* 10. Where are most of the clinical trials you are involved in conducted?

Africa

Australia

Central America

South America

Canada

China

Eastern Europe

Western Europe

India

Japan

Middle-East

Russia

United Kingdom

United States of America

Other (please specify)

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* 11. We plan to present and publish the overall results of this survey and help increase awareness. If you would like to know more about how Estimands can be applied to improve the design, conduct, analyses, and reporting of your trials please provide your email and we will forward you presentations of our results and links to additional useful information online.

ICH Guidance Impacting Clinical Trials

Question Title

* 1. What is the type of Company you work for?

Question Title

* 2. What is your primary area of expertise?

Question Title

* 3. How many years have you been involved in Clinical Research?

Question Title

* 4. Are you familiar with clinical trial endpoints?

Question Title

* 5. Do you feel missing data in clinical trials may make interpretation of results difficult?

Question Title

* 6. Are you aware of the 1998 ICH E9 guidance on Statistical Principles for Clinical Trials?

Question Title

* 7. Did you know a final addendum ICH E9 R1 was issued to this guidance on Estimands and sensitivity analyses on 20 Nov 2019?

Question Title

* 8. Have you applied the concept of Estimands in designing your clinical trials?

Question Title

* 9. What sources do you use to keep up with current regulatory requirements for clinical trials?

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* 10. Where are most of the clinical trials you are involved in conducted?

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* 12. Any other comments/suggestions for us including challenges you have faced in implementation of Estimands and ICHE9(R1).