Navigation Links
ISPE Patient Initiative Issues Survey Regarding Patient Experience with Clinical Materials
Date:6/10/2013

TAMPA, Fla., June 10, 2013 /PRNewswire-USNewswire/ -- ISPE, the International Society for Pharmaceutical Engineering, announced today it is currently conducting a global survey on patient experiences with clinical trial materials. The survey is designed to obtain feedback on areas such as the suitability of clinical trial packaging, label information and design, interacting with clinical trial technologies, and transportation and storage. With a target of 2000 or more patients from around the world, this study is the first known of its kind in size and scope.

(Logo: http://photos.prnewswire.com/prnh/20120912/DC73253LOGO)

"To ensure product integrity and patient safety, most technology and decisions in the Investigational Products (IP) arena focus on cGMP processes and activities," says ISPE President and CEO Nancy S. Berg. "As a result, decision-making can occur without good information about the downstream implications to Good Clinical Practice (GCP)-related activities at the study sites or the compliance of patients participating in the clinical trials. This study is designed to gather information that will help the pharmaceutical industry begin to close the information gap and ensure our patients receive quality products."

The survey was developed by a task force of industry experts engaged with ISPE's Investigational Products Community of Practice (IP COP). It was reviewed by global industry leaders and by experts from the non-profit Center for Information and Study on Clinical Research Participation (CISCRP). CISCRP is assisting ISPE in deploying the survey to its patient contacts around the world, handling all direct patient-related activity, and ensuring the data set ISPE ultimately analyzes is both wholly anonymous and consistent with the survey criteria.  

The goals of the study are to provide information and analysis that will:

  • Foster an understanding of patient experiences with IPs to support informed decisions around future design and management of study materials, leading to more efficient and effective studies as well as enhancing patient compliance.
  • Help the industry discern the impact of key differentiators on the patient experience with IPs, equipping professionals with information to determine when adjustments are needed to ensure the highest level of patient protocol compliance.

The study has been made possible by the generous support of eleven underwriting companies. Their investment in the mission and work of ISPE has allowed the task force to design and carry out this comprehensive project to the ultimate benefit patients around the world. ISPE wishes to thank the underwriters including:

  • Almac Clinical Services
  • Boehringer Ingelheim Pharma GMBH & Co.
  • Catalent Pharma Solutions
  • Cenduit LLC
  • Merck Sharp & Dohme Corporation
  • Novartis Pharma AG
  • Novo Nordisk A/S
  • PAREXEL International
  • Pfizer Inc.
  • Takeda Global Research & Development Centre (Europe), Ltd
  • UCB Pharma S.A.

 "Ensuring that clinical trials are as successful as they can possibly be constitutes a win for all ISPE stakeholders," says Berg. "Moreover, in the future we believe that the experience of the patient will and should have a bigger impact on cGMP decisions concerning clinical materials. This survey is a critical first step."

An update on the study will occur 13 June 2013 at ISPE's Conference "World-Class Supply End-to-End" in Prague, Czech Republic. On that date and thereafter, ISPE will host a website section devoted to its Patient Initiative featuring the latest information about the survey at www.ISPE.org/PatientInitiative. In July, an article providing background on the study design will be published in Pharmaceutical Engineering Magazine. Full study results will be announced in conjunction with ISPE's Annual Meeting in November 2013.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit www.ISPE.org for more information.

For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
email: dhould@ispe.org
www.ISPE.org  


'/>"/>
SOURCE ISPE
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Study Showed Patients Treated With The miraDry© System Experienced 82 Percent Sweat Reduction On Average
2. Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
3. Watching, Reading and Listening: A New Way to Interact with Patient Information
4. Phreesia identifies over 26% of patients who require additional autism evaluation
5. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
6. Almost 50 Percent of the Glaucoma Patient Population Remains Untreated, Signifying a Vast Market for Glaucoma Pharmaceuticals, Finds Frost & Sullivan
7. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
8. New post-hoc analyses examined Neupro® effects on pain, depressed mood, apathy and fatigue in patients with Parkinsons disease
9. Patient Advocate Foundation Announces New Co-Pay Relief (CPR) Offerings for Patients Facing Health Issues Due to Electrolyte Imbalance
10. Quest Diagnostics Establishes Unique Healthcare Identifier to Improve Access to Vital Patient Health Information; 80 Million Patient IDs Created to Date
11. Retrospective Study Suggests that Stereotactic Ablative Radiotherapy (SABR) Can be a Viable Option for Treating Early-Stage Lung Cancer in Operable as well as Inoperable Patients; Phase III Randomized Trial Now Under Way
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/5/2016)... May 5, 2016 ... addition of the  "Europe Thrombocytopenia Market ...  report to their offering.  ... , ,The latest research Europe Thrombocytopenia ... 2016, provides comprehensive insights into Thrombocytopenia ...
(Date:5/4/2016)... -- Compass Diversified Holdings (NYSE: CODI ) ("CODI," ... middle market businesses, announced today its consolidated operating results ... First Quarter 2016 Highlights , Generated Cash ... Flow") of $13.6 million for the first quarter of ... for the first quarter of 2016; , Paid ...
(Date:5/4/2016)... Israel , May 4, 2016 ... that BiondVax,s CEO, Dr. Ron Babecoff , will be ... New York City . On Thursday, May ... 2016, a conference presented by Joseph Gunner & ... The BiondVax presentation that Dr. Babecoff will be using ...
Breaking Medicine Technology:
(Date:5/6/2016)... PA and LONDON, UK (PRWEB) , ... May 06, 2016 , ... ... accolades for his success in changing the way the pharmaceutical industry conducts clinical trials. ... of the world’s most influential people in pharma, and he was honored as a ...
(Date:5/6/2016)... ... May 06, 2016 , ... Bluvault ( Bluvault Inc. ) ... for global clients of Coupa ( Coupa Software ) and other Cloud software, ... a key component in the suite of innovative implementation services offered by Bluvault. ...
(Date:5/6/2016)... ... May 06, 2016 , ... From May 4 to 6, ... members the unique opportunity to learn more about Signia’s technology and the successful business ... “It is our priority to see practices succeed in this highly competitive industry,” said ...
(Date:5/6/2016)... ... May 06, 2016 , ... Multiple award winning plumbing ... for over 35 years. Maintaining core values of exceptional customer service, quality work at ... them a leading name in San Diego plumbing, and other services including heating & ...
(Date:5/6/2016)... ... May 06, 2016 , ... ... David Konur, CEO of Cardiovascular Institute of the South announced today that Dr. ... a live case of an Intravascular Ultrasound Guided Coronary Atherectomy. , ...
Breaking Medicine News(10 mins):