spacer
home > ict > spring 2018 > optimising outcomes
PUBLICATIONS
International Clinical Trials

Optimising Outcomes

A patient-reported outcome (PRO) is a measurement based on a report that comes from the patient (ie, study subject) about the status of their health condition without amendment or interpretation of the report by a clinician or anyone else. A PRO can be measured by self-report or interview, provided that the interviewer records only the patientís response. Symptoms or other unobservable concepts known only to the patient (eg, pain severity or nausea) can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others, such as quality of life, time to pain progression, and time to deterioration of physical symptoms.

In 2016, the American Society of Clinical Oncology (ASCO) reported the FDA indicated that benefits in PROs can be the basis for full drug approval (1). While this is true and PROs are clearly the best way to collect patient data in clinical trials, the American Medical Association points out that other challenges exist that many oncology studies struggle to overcome: small patient numbers, very sick or terminally ill patients, high failure rates, and single-arm studies unique to the development of new therapies in oncology (2). For this reason, careful thought must go into designing and implementing PRO measures in the oncology clinical trial setting (3).

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
Katie Garner is Therapeutic Areas Advisor at CRF Health. She is responsible for providing specific therapeutic advice and supporting the therapeutic, sales, marketing and product development teams. Previously, Katie worked as a Project Manager for a Health Outcomes Consultancy and at the NHS Purchasing and Supply Agencies Centre for evidence-based purchasing. She also worked for the Medicine and Healthcare Products Regulatory Agency as a Senior Medical Device Specialist where she was responsible for the safety and regulation of in vitro diagnostic and contraceptive medical devices.
spacer
Katie Garner
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

ACG CAPSULES SET FOR EUROPEAN EXPANSION

ACG Capsules, one of the largest manufacturers of empty hard capsules (part of the ACG Group), demonstrated its commitment to European expansion by completing a series of appointments across the region.
More info >>

White Papers

Clinical Trials in Russia Orange Paper: Summary of Year 2013

Synergy Research Group

Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials. Sponsors mention the following reasons for conducting studies in Russia: 1. Fast patient enrollment due to the centralized medical infrastructure. 2. Nearly 100% patient retention 3. GCP trained and certified Investigative Sites generating high quality data 4. Low cost: Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
More info >>

 
Industry Events

Outsourcing in Clinical Trials Medical Device USA 2018

11-12 July 2018, Minneapolis, Minnesota

6th Outsourcing in Clinical Trials conference is the only clinical outsourcing platform for medical device companies within Medical Alley this year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement