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The "chronic problem" of clinical trial delays can be mitigated if sponsors take proactive steps such as better educating the public, working more closely with regulators and leveraging new technologies, said experts at a May 3 webinar sponsored by the Drug Information Association.
Sponsors confronted with a clinical trial adverse event (AE) must also be prepared for scrutiny regarding how they selected and set up their data safety monitoring board (DSMB), expert Mark Barnes warned at an April 24 FDAnews audioconference.
The European Union recently implemented the EU Clinical Trials Directive (CTD) to better protect clinical trial participants while streamlining the bureaucracy to make the EU more attractive for clinical research (CTA, Nov. 17, Page 1).
While electronic data capture (EDC) promises many benefits, the jury is still out on how much time and money it will ultimately save for clinical trials, says a veteran of dozens of trials in the U.S. and Canada.
Inna Kassatkina, cofounder and president of Global Language Solutions (GLS), a full-service translation company, spoke with CTA about the increasing number of international trials and the need for culturally and linguistically accurate translations of informed consent forms and protocols.
A clinical investigator who initiates a clinical study accepts ownership for everything that takes place during the course of the study, from planning and design through implementation and post-study activities.
Just in time for allergy season, the FDA granted fast-track status to Accentia’s drug SinuNase, a treatment for chronic sinusitis (CS), the company said April 12.
When a clinical trial goes wrong, a “subject” will often begin to call themselves “patients,” and that’s where a sponsor’s real problem can begin, attorney Wayne Bond told CTA last week.
Clinical trial sponsors will need to implement electronic data capture (EDC) quickly and turn their attention to the growing patient base in international markets if they want to survive, an industry expert said.
The highly publicized health problems suffered by several participants in TeGenero’s UK-based clinical trial for TGN1412, an immune-boosting drug, have raised new questions about patient protection and informed consent issues in trials.