Navigation Links
New Rhinosinusitis Clinical Trials Guidance Developed

More than 30 million Americans can attest that rhinosinusitis – an often recurring combination of congestion, discolored nasal discharge//, cough, and headache – seriously affects their quality of life.

A group of 25 physicians from five national medical societies has collaborated to design the first clinical trial guidelines for researchers working to find the most effective treatments for rhinosinusitis.

The U.S. Food and Drug Administration (FDA) has issued specific guidance documents for designing clinical trials of certain diseases, including acute bacterial sinusitis, but there has not been a guidance document put forth for chronic rhinosinusitis clinical trials. “Rhinosinusitis: Developing Guidance for Clinical Trials,” bridges this gap and offers researchers specific recommendations for rhinosinusitis clinical trials pertaining to acute bacterial rhinosinusitis, chronic rhinosinusitis with or without nasal polyps, and allergic fungal rhinosinusitis.

The guidelines will be published in November 2006 in a supplement of the American Academy of Allergy, Asthma and Immunology’s (AAAAI) Journal of Allergy and Clinical Immunology (JACI) and in the American Academy of Otolaryngology – Head and Neck Surgery/Foundation’s (AAO-HNS/F) white journal, Otolaryngology – Head and Neck Surgery. The corresponding author is Eli O. Meltzer, MD, Co-Director, Allergy and Asthma Medical Group and Research Center, San Diego, CA.

“The goal of the Rhinosinusitis Initiative has been to provide researchers with the needed methodologies which will promote better clinical studies that can lead to improved patient care,” Meltzer said.

Key components of the guidance include:
?Reviewing FDA’s role in drug trials.
?Presenting guidance for rhinosinusitis clinical trials of antimicrobials, anti-inflammatory treatment, and symptom reliever or mediator blocker treatments.
?Recommending scoring instruments for symptoms, rad iographs, endoscopic testing, and quality of life assessment.
?Recommending techniques for quantifying microbiologic factors, assessing inflammatory indices, and statistically measuring outcomes.

“Rhinosinusitis: Developing Guidance for Clinical Trials” offers a comprehensive list of rhinosinusitis clinical trial components ranging from the title of the trial, to study design, objectives and safety assessments.

The five societies involved in the collaboration include: the American Academy of Allergy, Asthma and Immunology (AAAAI); the American Academy of Otolaryngic Allergy (AAOA); the American Academy of Otolaryngology – Head and Neck Surgery/Foundation (AAO-HNS/F); the American College of Allergy, Asthma and Immunology (ACAAI); and the American Rhinologic Society (ARS).

This is the group’s second collaboration. Its original document, “Rhinosinusitis: Establishing Definitions for Clinical Research and Patient Care,” was published concurrently in the December 2004 editions of the JACI and OTO-HNS and can be found at http://journal.entnet.org. The document, which led to “Rhinosinusitis: Developing Guidance for Clinical Trials,” was a catalyst for further research on this disease. The participants in the effort agree that promoting more research on both acute and chronic rhinosinusitis is essential, and a better understanding of the cause of these diseases is needed.

Soure-Newswise
SRM
'"/>




Related medicine news :

1. Clinical trials need to be more frank
2. Physicians Lack Clinical Guidelines For Treating Elderly With Multiple Illnesses
3. The Growing Rise In Clinical Research Could Lead To A Compromise In Quality Of Research And Ethics
4. Clinical Comparisons Between ADHD Drugs Are Less
5. A Novel System For Clinical Banking Of Umbilical Cord Blood
6. Clinical Renal Trails Do Not Have Sufficient Women Participants
7. Clinical Trials of New Drug Febuxostat Show Promise in Gout Treatment
8. Clinical Trials Of New Anti-Cancer Drug To Be Initiated In New Zealand
9. Green Tea Consumption Found To Improve Clinical Outcome In Cancer Patients
10. Cancer Clinical Research in India
11. New Generation Clinical Trials Could Save Time And Money, Improve Patient Care
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/24/2017)... ... 2017 , ... The Pennsylvania Athletic Trainers’ Society’s (PATS) Annual ... Convention Center on June 8-10. The weekend consisted of many educational presentations, ... scholarship presentations, and professional networking. , On Friday June 9th, PATS hosted ...
(Date:6/23/2017)... ... 2017 , ... The Rhode Island Quality Institute (RIQI) and ... Dashboards, an innovative new service enabling healthcare providers to proactively coordinate care and ... Dashboards provide near real-time data about patients admitted to and/or discharged from acute ...
(Date:6/23/2017)... ... ... Studies show evidence that carotenoids and antioxidants derived either from the diet or from ... how often do ophthalmologists and optometrists in Sweden recommend the use of nutritional supplements, ... symptoms of AMD? A study published recently in Dove Medical Press journal, ...
(Date:6/23/2017)... ... June 23, 2017 , ... Everybody has their own personal preference when ... read it, and some people don't like it at all. FindaTopDoc took a look ... , Erotic literature can give readers a taste of their deepest, darkest fantasies and ...
(Date:6/23/2017)... ... June 23, 2017 , ... Georgia State ... 18 to 20. , The two-day conference is focused on advancing scientific knowledge ... improving patients’ lives and eliminating racial breast cancer-related disparities. The conference theme is ...
Breaking Medicine News(10 mins):
(Date:6/8/2017)... 8, 2017  StatLab Medical Products ("StatLab" ... manufacturer of diagnostic supplies for the anatomic ... & Company LP ("Cressey & Company"), a ... growth-focused investment in the Company. Cressey & ... from selling shareholder, Prairie Capital, L.P., with ...
(Date:6/7/2017)... , June 7, 2017  Novavax, Inc., (Nasdaq: ... two Phase 2 trials of its RSV F protein recombinant ... bearing age have been published in the journal ... been shared in prior scientific conferences). The Company previously announced ... 2014. Novavax is developing the RSV F Vaccine with the ...
(Date:6/5/2017)... , June 5, 2017 The ... brand of Diplomat Pharmacy, Inc. (NYSE: DPLO), has been awarded ... Cincinnati Enquirer . Results are based on an ... in organizational health and workplace improvement. The survey measures several ... ...
Breaking Medicine Technology: