samedan logo
 
 
spacer
home > ict > autumn 2017 > restricting regulations
PUBLICATIONS
International Clinical Trials

Restricting Regulations

Contemporary medicine has come a long way since the days of snake oil salesmen. Today, patients can be assured that prescribed medicine has been vetted for safety and efficacy through a long and arduous process, guided by governmental regulatory agencies. The central pillar of this rigorous procedure for current drug approval is the human clinical trial, the success of which has resulted in a proliferation of studies worldwide. Since the international committee of medical journal editors established trial registration requirements in 2005, enrolment has increased fivefold (1). In the US alone, clinical trial registration has increased tenfold during this same time period, but, against this backdrop, the EU recorded a concerning 25% decrease in clinical trial applications (CTA) from 2007 to 2011 (2).

Global Trials

One of the issues affecting the number of EU studies is a growing trend towards globalisation, with a recent rise in those conducted in developing countries. For example, the number of countries serving as study locations outside the US has more than doubled in the past 10 years, and the proportion of trials undertaken there and in Western Europe has reduced significantly (3,4).

Several factors drive this globalisation trend – one of them being the spiralling drug development costs. A 2013 study by the Tufts Center for the Study of Drug Development estimates the average expense to develop and gain market approval for a new therapeutic is $2.6 billion – up 145% from a similar investigation conducted in 2003 – with time costs accounting for half of that amount. The time and investment required to conduct trials is the largest contributor to these increases, and, given that the success rate for medications moving through clinical trials to FDA approval is a mere 10%, the pharmaceutical industry is struggling to sustain profitability (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
Craig Morgan is Head of Marketing at goBalto, a life sciences software as a service technology organisation. He works with sponsors, CROs, medical device manufacturers and sites to reduce cycle times and improve collaboration and oversight in clinical trials. Craig is a technology and life sciences management professional, with over 15 years’ experience in informatics and bioinformatics applications to drug discovery. He holds degrees in analytical chemistry, information systems and business administration and is a certified
spacer
Craig Morgan
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Digital Manufacturing is a top priority for Life Sciences according to Zenith survey

Zenith Technologies, a world leader in delivering GMP manufacturing software solutions to the life sciences industry, recently conducted an industry survey that suggests the digital manufacturing is a top priority.
More info >>

White Papers

The current and future role of the medical oncologist in the professional care for cancer patients: a position paper by the European Society for Medical Oncology

European Society for Medical Oncology (ESMO)

  The number of cancer patients in Europe is rising and significant advances in basic and applied cancer research are making the provision of optimal care more challenging. The concept of cancer as a systemic, highly heterogeneous and complex disease has increased the awareness that quality cancer care should be provided by a multidisciplinary team (MDT) of highly qualified healthcare professionals. Cancer patients also have the right to benefit from medical progress by receiving optimal treatment from adequately trained and highly skilled medical professionals. Built on the highest standards of professional training and continuing medical education, medical oncology is recognised as an independent medical specialty in many European countries.
More info >>

 
Industry Events

Digital Medicine & Medtech Showcase 2019

8-9 January 2019, Parc 55 San Francisco - a Hilton Hotel

The Digital Medicine and Medtech Showcase is the dedicated home for the digital health and medtech communities during Biotech Showcase™ and one of the healthcare industry’s biggest weeks. Taking place January 8–9, Digital Medicine & Medtech Showcase includes two days of networking opportunities, curated presentations, specialized sessions, one-to-one meetings scheduled by partneringONE®, and full access to Biotech Showcase.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement