Patient Recruitment and Retention
Addressing Clinical Trial Recruitment and Patient Retention Issues Imposed by HIPAA Step by Step (third of a series)
Patient Retention
Recent reports have indicated that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct and patient retention by imposing significant time and cost burden and by impeding clinical trial recruiting and patient retention,1 which in turn has deterred patient search efforts–locating patients lost-to-follow-up. [...]
Addressing Clinical Trial Recruitment and Retention Issues Imposed by HIPAA Step by Step (second of a series)
Clinical Trial Recruitment
Recent reports have indicated that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct by imposing significant time and cost burdens, and by impeding clinical trial recruitment and retention,1 which in turn has deterred finding patients lost-to-follow-up (LTFU). This post will serve [...]
Addressing Clinical Trial Recruitment and Retention Issues Imposed by HIPAA Step by Step (first of a series)
Recent reports indicate that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct by (a) increasing researchers’ administrative burden; (b) increasing overall trial conduct costs; (c) delaying initial project approval; (d) hampering medical record and registry research, and most critical; (e) impeding clinical trial recruiting [...]
22Aug2008 | admin | 0 comments | Continued
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- Recalls and Safety Alerts: Serious Infections and Neurological Events with Raptiva January 1, 2009
- Recalls and Safety Alerts: Recall of ReliOn Insulin Syringes January 1, 2009
- Recalls and Safety Alerts: Ethex Corp. Recalls Several Generic Drugs January 1, 2009
- Recalls and Safety Alerts: Serious Complications with Surgical Mesh for Gynecologic Surgery January 1, 2009
- Preventing Medical Errors: More Mix-ups between Propylthiouracil and Purinethol January 1, 2009
