Pfizer and GlaxoSmithKline have each entered the twilight zone of the drug business, via FDA's request that Pfizer halt a pain medication trial and its notification to GSK of a partial clinical hold for its large Avandia safety trial. Within that twilight zone lies the sector of subject data interruption, the navigation of which can help or hinder a drug throughout its lifecycle if, in fact, the drug survives the clinical hold.
In suspended trials, both existing data and data yet to be collected as planned according to protocol are affected.
Pfizer announced last week a suspension of some tanezumab trials for back pain and diabetic neuropathy. The action is a clinical hold, in which researchers suspend both subject recruitment and the dosing of those already enrolled. The post-marketing Avandia TIDE trial, by contrast, has been put on partial clinical hold: No new subjects can be enrolled, but those already recruited can continue their participation.
Trial holds have "multiple shapes and flavors," says Bonnie Brescia, co-founder and president at subject recruitment specialist BBK Worldwide, in a phone interview with FierceBiotechIT. Once a trial is suspended, the disposition of data collected and requirements for additional data collection are developed on a protocol-by-protocol, regulator-by-regulator basis.
"In some cases, the partial data has to be destroyed," says Brescia. "Other regulators will ask you to keep it, depending on the protocol." Additional data collection may be required when safety issues have forced trial suspension, for example. Regulators sometimes mandate extra monitoring visits several months out. And researchers may have to get existing trial subjects to re-consent.
For the TIDE trial, the FDA has "instructed" GSK to update investigators, institutional review boards and ethics committees regarding recent safety information, according to a statement. Most e-clinical and company IT systems will provide for communication with these stakeholders.
But to reach subjects, as in cases when re-consent is required, sponsors have to go through the investigative sites. "The hard part is getting the information out," says Brescia. Some of these sites are more automated than others. "You use the technologies that they are focused on."
- here's the GSK release
- see the Pfizer announcement
- read the FDA statement