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 patients 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

The need for a blueprint emergency plan to avoid a HPAPI crisis

SMi reports: Taro Pharmaceuticals, Purdue Pharma and Sakari Consultants to present at HPAPI USA taking place on October 21st 22nd in Boston
More info >>

White Papers

A Rules Based Approach to Labelling and Artwork Management

Kallik

Many organisations today are experiencing unprecedented demands from regulatory authorities and consumers alike for product labelling to be made clearer and more informative. Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) also require that labelling content to be published electronically in addition to print. As companies seek to continuously differentiate themselves in established markets as well as gain entry into new territories, the increase in both volume and complexity of product and market variations will have a direct impact on labelling.
More info >>

 
Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement