Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com
Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com
Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com
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Determ<strong>in</strong><strong>in</strong>g Need for DSMB<br />
• What is the risk to trial participants?<br />
• An <strong>in</strong>terim analysis of a study endpo<strong>in</strong>t<br />
could be so highly favorable or<br />
unfavorable that study term<strong>in</strong>ation<br />
would be required<br />
• Reasons exist for a safety concern<br />
• Fragile population<br />
• Large, long duration and multicenter<br />
trial