spacer
home > ict > autumn 2019 > the pacific rim
PUBLICATIONS
International Clinical Trials

The Pacific Rim





In the US and EU, approximately 35% of trial delays occur as a result of patient recruitment, and one-fifth of the trials in these countries do not enrol a sufficient number of subjects. Shown in Figure 1, to expedite the recruitment process and avoid drug approval delays, both the US and EU have increased their number of registered clinical trials in developed Asian countries such as Japan, South Korea, China, India, and Malaysia (1).

It is well known that the primary barriers to conducting clinical trials in the US and Western Europe involve challenges in participant recruitment and retention, resulting in longer lead times and high costs (2). Furthermore, contracting qualified and experienced investigators and key opinion leaders add to the already lengthy trial times (3).

A 2013 analysis found that almost 57% of trials fail due to low patient accrual rates, which could translate into huge financial losses (4). Adding to this recruitment problem, racial and ethnic minorities, women, and the elderly are often under-represented in enrolments. For example, a study found that only 25% of elderly cancer patients enrol in trials, although they account for 63% of new cancer cases (5).

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
About the author

As Chief Medical Officer of Linical Accelovance Group, Dr Tracy Goeken is responsible for providing strategic and operational leadership regarding the company’s global medical and scientific operations. Dr Goeken oversees clinical development functions and activities within the company, including medical, regulatory, medical writing, and pre- and post-market pharmacovigilance departments ensuring global alignment and operational excellence. Tracy received his MD from St. Christopher’s College of Medicine, UK, having completed his clinical training at LSU Health Sciences Center in Louisiana.
Print this page
Send to a friend
Privacy statement
News and Press Releases

Significant improvement in overall survival with ERLEADA®▼ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer

BEERSE, BELGIUM, May 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA®▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May.
More info >>

White Papers

Six Strategies to Stretch Your Limited Drug Supply for Clinical Studies

PCI Pharma Services

Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex therapies not only increase risk in drug development but also drive costs even higher. A recent analysis of the investment needed to develop a new prescription medicine shows the total cost can be as high as $2.6 billion (1). That number becomes even more staggering when you consider the fact that only about 12 percent of drug candidates that make it to Phase I testing are eventually approved by the FDA (2). The investment companies lose as a result may be too devastating to their bottom line to ever recover.
More info >>

 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement