spacer
home > ict > winter 2019 > advancing expansion
PUBLICATIONS
International Clinical Trials

Advancing Expansion

The UK has significant experience in first-in-human (FIH) clinical trials and has performed almost a quarter of the total of 2,206 FIH studies in the EU between 2005 and 2017 (Figure 1). Furthermore, the number of FIH trials conducted in the UK continues to increase; 69 out of 143 (48%) Phase 1 trials in 2016 were FIH, whereas, in 2017, this number grew to 105 out of 167 (63%) (1). The collective experience of regulators, clinical Phase 1 units, and FIH principal investigators in the last couple of decades has played a significant role in the development of guidelines for FIH/early phase clinical trials. However, two events come to the forefront of any early clinical developerís mind in relation to the guidance issued by the EMA in this area.

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
Dr Simon Hutchings has over 11 years of experience in the drug development process, including preclinical pharmacology/toxicology, Phase 1 (including first-in-human) pharmacology/ PK studies, and investigator-led Phase 2 and 3 trials. In addition to undergraduate and postgraduate qualifications in pharmacology, he also holds a Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine at the Royal College of Physicians, UK. Simon has extensive practical experience and scientific knowledge of the design, management, and reporting of clinical development projects.
spacer
Dr Simon Hutchings
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

AirBridgeCargo expands its passive pharma solutions in partnership with SkyCell as it achieves the two-fold volume increase

AirBridgeCargo expands its passive pharma solutions in partnership with SkyCell as it achieves the two-fold volume increase AirBridgeCargo Airlines (ABC), one of the leaders in transportation of pharmaceutical products by air, and Zurich-based cold-chain ULD manufacturer SkyCell have sealed their partnership for the lease of all types of SkyCell containers to meet the demand for evolving volumes of passive pharmaceutical shipments, which reached around 3,500 tonnes for 1Q 2019 YOY and demonstrated a two-fold increase.
More info >>

White Papers

The Process of Informed Consent (written by ACRP)

CenterWatch

Every investigator and clinical research coordinator (CRC) should recognize the importance of obtaining valid and appropriate informed consent as an important protection of the rights and welfare of human subjects. The purpose of this ACRP guidance document is not to provide a literature review or summarize the recommendations of various working groups. Instead, the Association decided it would be helpful to provide short and focused guidance which describes how to best structure the informed consent process in accordance with best practices.
More info >>

 
Industry Events

ESMO Targeted Anticancer Therapies Congress 2020

2-4 March 2020, Paris, France

A unique and international mix of experts, researchers and decision makers both from academia and industry across the globe, will convene in Paris for a three-day Congress aiming at exchanging knowledge, experience and research innovations in cancer. TAT 2020 will focus, among others, on novel strategies in immuno-oncology, personalised medicine and molecular tumour boards, preclinical studies to identify effective combination therapies, use of microbiome, tumour agnostic trials, ADC technology, oncolytics, multispecific biological constructs and targeting cytokines. Participating in TAT 2020 will offer you the possibility to take part in interdisciplinary discussions inspiring new ideas and new collaborations.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement