Newsletter - June 4, 2020
FDA Released Free Electronic Informed Consent Tool but Will Anyone Use it?
This week FDA re-released a free tool for electronic informed consent to be used in clinical trials as an alternate to conventional paper-based informed consents. This is to help investigators obtain informed consent during the pandemic. But the tool seems to be of very limited functionality. It is hard to know if....Read More
Use of Surrogate Endpoints for FDA Approval is Common in Cancer Drugs
About 2 out of 3 cancer drug approvals between 1992 and 2019 were based on surrogate endpoints and about 1 out of 3 surrogate endpoints were used first-time for market approval. A recent survey challenges the wide use of surrogate endpoints over direct measures such as overall survival. Read More
FDA Released Free Electronic Informed Consent Tool but Will Anyone Use it?
This week FDA re-released a free tool for electronic informed consent to be used in clinical trials as an alternate to conventional paper-based informed consents. This is to help investigators obtain informed consent during the pandemic. But the tool seems to be of very limited functionality. It is hard to know if....Read More
Use of Surrogate Endpoints for FDA Approval is Common in Cancer Drugs
About 2 out of 3 cancer drug approvals between 1992 and 2019 were based on surrogate endpoints and about 1 out of 3 surrogate endpoints were used first-time for market approval. A recent survey challenges the wide use of surrogate endpoints over direct measures such as overall survival. Read More