spacer
home > ict > winter 2018 > dodging delays
PUBLICATIONS
International Clinical Trials

Dodging Delays

Thanks, in part, to earlier disease detection and effective treatments, patients are living longer. As a result, the follow-up period for patients in clinical trials is also being extended. Late recurrence, side effects, and treatmentrelated safety concerns are increasingly important for monitoring. However, patient retention becomes more difficult to achieve as the follow-up period gets longer, with an upsurge in patient drop-outs from 7.3% after 12 months of follow-up to 27% after 48 months (1,2). In fact, 81% of studies in a recent systematic review reported patients lost to follow-up (LTFU), accounting for 2-15% of patients (3).

Why are missing patients a concern? Patients who are LTFU result in missing data and a potential need to recruit additional patients to reach study power. These factors compromise the study budget, timeline, and data quality. Unfortunately, sites often lack the time and resources to track down missing patients, and, although specialist services are available to help find patients, not all provide the same level of service and expertise.

Compromising a Clinical Trial

Missing patients mean missing data. This is problematic when that data would be meaningful for analysis if those patients were available (4). This also introduces bias and could lead to questions regarding the validity of the entire study (3). Dropout rates are rarely the same between treatment groups, and determining if the patients with missing data differ from the patients with complete data is difficult. It has been suggested that 20% of missing patient data could represent a serious threat to validity, while less than 5% of missing data leads to little bias (5,6). However, even small numbers of patients who are LTFU can cause significant bias (7,8).

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
Martin Collyer is a Senior Healthcare and Life Sciences Executive with more than 20 years of experience and a focus on multi-site global operations management. He enables organisations to expedite patient enrolment leveraging therapeutically aligned global patient engagement platforms and digital methodologies. Martin is a qualified Chartered Certified Accountant, with a degree in strategic financial planning and management. Prior to joining Bioclinica in 2016, he was Chief Operating Officer of MediciGroup, acquired by Bioclinica.
spacer
Martin Collyer
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Teknomek’s latest seating bench steps up, and over

Teknomek’s long-serving free-standing stainless steel seating bench has been updated with a raft of design tweaks to make it even more hygienic, easy clean and ergonomic.
More info >>

White Papers

Biosimilars In Emerging Markets: Is It A Level Playing Field?

PRA Health Sciences (PRA)

Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need. At its best, the global expansion of biosimilars can mean a robust and steady supply of existing and new drugs reaching far-flung patient populations, but localized biosimilar drug developments, especially in China and India, combined with a lack of robust pharmacovigilance systems, threaten to derail the industry by putting patient health at risk.
More info >>

 
Industry Events

SMi’s 9th Annual Biosimilars & Biobetters Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Following the success of our previous events in both London and the US, Biosimilars and Biobetters UK 2018, SMi deliver a stellar speaker line-up and bring together a global audience of biosimilar experts to discuss the latest developments and future of the rapidly evolving and expanding biosimilars market.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement