spacer
home > ict > spring 2008 > raising the bar
PUBLICATIONS
International Clinical Trials

Raising the Bar

Alan Morgan of ICON Clinical Research, Europe, assesses how best to implement new standards in patient recruitment in order to achieve beneficial and effective practice

The patient recruitment methods increasingly being used by CROs involve a more scientific and targeted approach, which should become a new standard for best practice within the industry. This approach involves the use of a comprehensive in-house database covering a wide range of countries and therapeutic indications, and also includes performance data on investigators. By systematically searching the database at both a macro (country) and micro (within a specific country) level, a CRO can start the process to identify the best countries, sites and investigators in order to ensure optimum patient recruitment for a client.

The use of performance data is a major step forward in terms of how CROs operate. This approach relies on both the quality and quantity of the data in the database; it can therefore be used most effectively by larger CROs that have more extensive global and therapeutic indication coverage. Traditional feasibility studies are still required, but the focus on investigator performance can make this approach much more effective in identifying motivated investigators who have access to appropriate patients.

PREPARING THE DELIVERY STRATEGY

In order to successfully execute and deliver an effective clinical trial programme, a CRO needs to invest considerable time and effort preparing a delivery strategy prior to being awarded a contract. The most important part of this process is the initial identification of the best investigator sites in an attempt to ensure optimum patient recruitment. This process is aided by having experienced and empowered project managers in charge of patient recruitment. Other key aspects are to have contingency plans in place in order to deal with any problems or issues that may arise, and a ‘toolkit’ of tactics and approaches to enhance patient recruitment.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

 You must be a member of the site to make a comment.
spacer
Alan Morgan is President of ICON Clinical Research, Europe. Alan is responsible for the Phase II/IV business in the region. He joined the company in August 2006 as Vice President for Process Development. He was Global General Manager of the Phase II/IV business of MDS Pharma Services from August 2005, having joined MDS in September 2002 as General Manager of their European, Latin American and Asian Clinical Development operations. Alan’s initial career was in pharma, including seven years with Glaxo Wellcome and two years with ICI Pharmaceuticals in various business financial roles. He is a graduate of the City University Business School in London and a Fellow of the Chartered Association of Certified Accountants.
spacer
Alan Morgan
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Samsung Biologics Reports Third Quarter 2022 Financial Results

Recorded consolidated revenue of KRW 873 billion in Q3’22, and recorded consolidated operating profit of KRW 324.7 billion in Q3’22. Also started partial operations at Plant 4 within 23 months since groundbreaking as previously committed and launched two
More info >>

White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement