ABSTRACT
BACKGROUND: Every phase of a clinical trial should be designed in compliance with good clinical practices by following all relevant regulatory guidelines. Patient safety, data integrity and ethics are an integral part of a successful clinical trial which must be considered. Therefore, risk monitoring is an essential tool to identify the risks associated with conduct of any trial. This article is a result of extensive research conducted by a reputed pharmaceutical company to identify the potential stages of risks associated with the conduct phase of trial that could impact the overall quality and safety of a trial. METHODS: The skillful and experienced team members of a reputed pharmaceutical company involved in conducting clinical trials underwent brainstorming sessions to assess and categorize the risks associated with each stage of conduct phase of a clinical trial. They also developed a mitigation plan based on their experiences, best practices and applicable guidance documents. RESULTS: During conduct phase, risks are associated with preparation of site master and trial master file, courier of study supply to site(s) including investigational product prior to site initiation visit, patient recruitment, telephonic monitoring, adverse or serious adverse event monitoring, site monitoring visit(s), collected case report form pages forward to data management vendor, data query clarification and site close-out visit. CONCLUSION: A close working relationship with all the persons associated with the clinical trial, timely monitoring and prospective mitigation planning is required for the conduct of a high quality trial.
Subject(s)
Clinical Trials as Topic/organization & administration , Guidelines as Topic , Patient Selection , HumansABSTRACT
OBJECTIVE: An evaluation of safety and efficacy of high molecular weight hyaluronan (HA) delivered at the time of arthroscopic debridement of the osteoarthritic knee. METHODS: Thirty consecutive patients who met inclusion and exclusion criteria underwent arthroscopic debridement by a single surgeon and concomitant delivery of 6 ml/90 mg HA (Orthovisc). These patients were evaluated preoperatively, at 6 weeks, 3 and 6 months post-operatively. Evaluations consisted of WOMAC pain score, SF-36 Physical Component Summary (PCS) score and complications. RESULTS: No complications occurred during this study. Pre-op average WOMAC pain score was 6.8 +/- 3.5 (n = 30) with a reduction to 3.4 +/- 3.1 at 6 weeks (n = 27). Final average WOMAC pain score improved to 3.2 +/- 3.8 at six months (n = 23). No patients had deterioration of the WOMAC pain score. Mean pre-operative SF-36 PCS score was 39.0 +/- 10.4 with SF-36 PCS score of the bottom 25th percentile at 29.9 (n = 30). Post procedure and HA delivery, mean PCS score at 6 weeks improved to 43.7 +/- 8.0 with the bottom 25th percentile at 37.5 (n = 27). At 6 months, mean PCS score was 48.0 +/- 9.8 with the bottom 25th percentile improved to 45.8 (n = 23). CONCLUSION: The results show that concomitant delivery of high molecular weight hyaluronan (Orthovisc--6 ml/90 mg) is safe when given at the time of arthroscopic debridement of the osteoarthritic knee. By delivering HA (Orthovisc) at the time of the arthroscopic debridement, there may be a decreased risk of joint infection and/or injection site pain. Furthermore, the combination of both procedures show efficacy in reducing WOMAC pain scores and improving SF-36 PCS scores over a six month period.
