From Laboratory Bench to Registration and Marketing Approval: Clinical Development for the Biomaterial Developer

The Various Regulatory Clinical Development Pathways to Obtain Marketing Approval

Drug Information Journal ◽

10.1177/009286159703100412 ◽

1997 ◽

Vol 31 (4) ◽

pp. 1149-1153 ◽

Cited By ~ 1

Author(s):

Thomas A. Hayes ◽

D. P. Gangi

Keyword(s):

Clinical Development ◽

Marketing Approval

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From Laboratory Bench to Registration and Marketing Approval

Biomaterials for Stem Cell Therapy ◽

10.1201/b14584-27 ◽

2013 ◽

pp. 594-618

Author(s):

Rita Dobmeyer ◽

Flavio De Rosa

Keyword(s):

Marketing Approval ◽

Laboratory Bench

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Vaccine Clinical Development

10.33442/vt202113 ◽

2021 ◽

Author(s):

Stephen Lockhart ◽

William Gruber

Keyword(s):

Vaccine Development ◽

Vaccine Candidate ◽

Phase 1 ◽

Target Population ◽

Clinical Development ◽

Marketing Approval ◽

Policy Makers ◽

Care Workers ◽

Target Disease ◽

Study Participants

Vaccine Clinical Development is an integrated part of the overall process of vaccine development, which involves clinical trials in which study participants are usually prospectively and randomly allocated to receive the vaccine candidate or a control vaccine. Participants are then actively monitored to generate information on safety, and often immune responses and/or cases of the target disease. Clinical development starts with small phase 1 studies in tens or hundreds of volunteers. In phase 2, volunteers in the target population are studied for safety and evidence of a desired effect, often an immune response. In phase 3, pivotal studies will generally examine prevention of the target disease with at least 3000 participants receiving the vaccine candidate. The key outputs are reports for regulatory agencies, policy makers and health care workers to support marketing approval and appropriate ways to use the vaccine. Clinical trial designs and results are made public through registries and peer-reviewed publications.

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