All Posts Tagged With: "clinical trial"
Electronic Medical Records Utility in Clinical Trial Conduct
Electronic Medical Records Utility in Clinical Trial Conduct
Patient dropouts and those lost to follow-up (LTFU) pose a major challenge and costly burden in the conduct of clinical trials as each patient represents a valuable source of data. High patient dropout rates are not only costly but pose a risk to the interpretation and validity of [...]
Impact Of HIPAA On Clinical Trial Conduct
Clinical Trial Conduct
Assuring full compliance of guidelines mandated by governing authorities is critical to conducting successful clinical trial research and to subsequent product approval. The federal government’s medical privacy rule, the Health Insurance Portability and Accountability Act (HIPAA), that went into effect in 2003 is such a mandate. It has greatly impacted the conduct of [...]
Efficiency of Clinical Trials Require Effective Recruitment, Retention and Return
Efficiency of Clinical Trials
Conducting clinical trials is becoming increasingly arduous for drug manufactures due to several factors including: (a) heightened food and drug (FDA) regulatory scrutiny based on recent safety concerns; (b) inefficiencies and/or unclear guidance imposed by Health Insurance Portability and Accountability Act (HIPAA) guidelines in the research, design, enrollment and follow-up processes; (c) [...]
Clinical Trial Recruitment | Retention Issues for Manufacturers of Diabetes Agents
Clinical Trial Recruitment | Retention
Anxiety lurks among manufacturers of type 2 diabetes drugs, especially those manufacturers who have drugs in late clinical development.
Recent FDA advisory committee recommendations have created an ongoing debate over whether Investigational diabetes agents should be subject to long-term cardiovascular safety. 1 A firm consensus has not been reached, however, several manufacturers [...]
FDA Patient Safety News- Preventing Medical Errors: Medical Errors from Misreading Letters and Numbers March 1, 2010
- Recalls and Safety Alerts: Cleviprex Recalled due to Particulates March 1, 2010
- Recalls and Safety Alerts: Don't Use Thermoflect Products with MRI March 1, 2010
- Recalls and Safety Alerts: Safety Precautions for Huber Needles March 1, 2010
- Recalls and Safety Alerts: Valproate Sodium and Birth Defects March 1, 2010
