spacer
home > ict > summer 2020 > outcome solutions in medical research
PUBLICATIONS
International Clinical Trials

Outcome Solutions in Medical Research


In central nervous system (CNS) clinical research, pharmaceutical sponsors pursuing CNS indications encounter numerous challenges stemming from the subjective nature of many CNS endpoints, variability of placebo response, and from measurement errors due to inconsistency in a site investigators’ assessment processes. CNS clinical trial sites also face formidable challenges related to recruiting and retaining appropriate patients, tight budgets, and increasing respondent burden due to the increasing number of endpoints, measures, and techniques required by modern protocols. Variability in rater experience, patient eligibility requirements, and the task of integrating multiple vendors and technology applications create additional hurdles to trial success.

A key challenge facing clinical trials in many CNS indications is in designing studies to optimise the opportunity to demonstrate efficacy by obtaining a true drug-placebo difference. For example, high placebo response rates in Parkinson’s disease, depression, mania, anxiety, and negative symptoms of schizophrenia are suspected to be a key reason for study failure.

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 Authors


Dr Bill Byrom serves as Vice President of product strategy and innovation at Signant Health, where he also leads a team of ePRO scientists. He has worked in the pharma industry for 30 years and is the author of over 70 publications and two industry textbooks on ePRO. Bill provides independent eClinical commentary via LinkedIn and Twitter (@billbyrom).

Dr Denis Curtin is Principal, eCOA and Patient Engagement, in the science and medicine practice at Signant Health. Denis’s experience includes more than 20 years in pharma industry roles leading drug and vaccine clinical development and commercial brand management, product lifecycle and franchise portfolio strategic planning, and clinical trial design and management.

Dr David Daniel is Signant Health’s Senior Vice President and Chief Medical Officer, and Clinical Professor of Psychiatry at George Washington University, US. He has over 25 years’ experience in supervising and conducting rater training and data quality management programmes in multi-site industry, government, and academic settings. David has received patent protection for new treatment approaches he invented in epilepsy, anxiety disorders, and motor side effects of antipsychotic treatment.

Dr Alan Kott is based in Signant Health’s Prague office and, until recently, was Senior Clinical Manager for Europe. Having led the development of the data analytics programme for Signant Health, he has overseen the design and reporting of data analytics in multiple large schizophrenia studies. For the past seven years, he has also provided training to investigators as an Expert Trainer. Alan has been responsible for the design and implementation of multiple in-study data quality programmes and served as a Product Business Owner for rater reliability statistical measures application.

Dr Gary Sachs is an internationally recognised expert clinical trialist with extensive experience in rater training and clinical trial methodologies for mood and anxiety disorder research. He has been instrumental in developing technology-based solutions for randomised controlled trials that identify correlates of high placebo response, improve signal detection, and reduce the risk of failed trials. As Principal Investigator of the National Institute of Mental Health sponsored Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), Gary led the largest treatment study ever conducted for bipolar disorder.
Print this page
Send to a friend
Privacy statement
News and Press Releases

IONTAS announces a new collaboration to identify novel immunotherapy targets

Cambridge, UK, 07 May 2020: IONTAS Limited (IONTAS), a leader in the discovery and optimisation of fully human antibodies, today announced it has entered into a collaboration agreement with Inotrem, a specialist in immunotherapy for acute and chronic inflammatory syndromes. As part of the agreement, IONTAS will apply its Mammalian Display technology to identify antibodies involved in the TREM-1 pathway.
More info >>

White Papers

PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content

Phlexglobal Ltd

Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive. As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
More info >>

 
Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement