spacer
home > ict > spring 2017 > odd one out
PUBLICATIONS
International Clinical Trials

Odd One Out

Over recent years, permissive science, innovative trial methodology, evolving regulatory sentiments and increasingly sophisticated commercialisation have all contributed to drug development. However, some challenges still remain. Poor understanding regarding the natural history of the proposed indication due to few observational trials studying disease progression, recruiting and retaining patients and investigators as well as regulatory uncertainties can all prove difficult, to detail just a few.

Facilitating Enrolment

A smaller selection of patients and, occasionally, a decreased likelihood of finding and engaging patient advocacy groups, means that identifying and locating participants can be extremely perplexing for orphan drug researchers.

The benefits of working with patient advocy groups are invaluable to researchers when attempting to seek out participants. These groups usually involve patient caregivers or relatives, as well as doctors and key opinion leaders (KOLs) in the specific indication. It is crucial for CROs, sponsors and investigators to reach out and communicate with these groups – especially during the initial stages of a protocol design – because having their cooperation at this point can be crucial to the success of a trial. By taking the time to meet and speak with members of any relevant groups, researchers can gain valuable insight into a particular condition – including what life is like for potential participants, as well as what is important to the caregivers and others in the patient’s network.

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.

spacer
Jeffrey Zucker is Senior Vice President of Global Clinical Operations at Worldwide Clinical Trials. His current responsibilities include growing and continually improving the company’s global and site feasibility capabilities. Jeffrey also oversees the evolving Patient Recruitment and Site Relations departments and has been in the clinical research industry for 20 years.
spacer
Zeffrey Zucker
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

WORLD’S FIRST PCM CARGO COVER

A British team of scientists at TLX Cargo Ltd have invented the worlds Cargo Cover/Thermal blanket that incorporates Phase Change Material (PCM) into it`s structure, solved the problem of hot lane temperature excursions on the tarmac.
More info >>

White Papers

Clinical Trials in Russia Orange Paper: 2nd Quarter 2014

Synergy Research Group

The Ministry of Health of Russian Federation approved 194 new clinical trials of all types including local and bioequivalence studies during the 2nd Quarter of 2014 (3% less than at the same period of the last year). The main contribution to the total number of studies was made by multinational multi-center clinical trials (MMCT) and the number of these studies stayed the same as in Q2 2013 – 81 studies. The number of bioequivalence studies (BE) decreased from 76 studies in Q2 2013 to 59 in Q2 2014, a 22% decrease from last year’s figure. The number of local clinical trials (LCT) increased from 42 in Q2 2013 to 54 clinical trials in Q2 2014.
More info >>

 
Industry Events

ACHEMA 2018

11-15 June 2018, Messe Frankfurt GmbH

ACHEMA is the world forum for the process industries, but also an integral part of the trade show calendar of companies specializing in pharma packaging. Every three years 3,800 exhibitors and 170,000 visitors gather in Frankfurt/Main, Germany for the trade show that features everything you need to furnish a chemical or pharma production plant.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement