Rescue studies have always been the part of the clinical trial world you hope you never need. Now you may be staring one in the face.
What Is A Rescue Study?
In short, a rescue trial or study is when you need to save a study that risks not being completed in time, has lost access to certain resources or has quality or reliability issues. This could be a paper trial or EDC and subject to any of a number of data collection methodologies. Often the solution is via a new Vendor/supplier.
What Are The Issues Caused By Coronavirus?
Many issues can arise during the course of a clinical trial and negatively affect a study timeline and quality demands. Right now there is one underlining issue that is affecting trials everywhere. Lockdowns, social distancing, working from home and business closures are impacting both sides of the equation – the ability of Sponsors and CROs to internally manage trials effectively AND especially the ability of subjects and trial researchers and investigators to meet face to face. This causes severe consequences to patient inclusions and visit schedules.
Rescue Study “Must Haves”
For any rescue study it’s imperative to enable study sites, the e ngine room of any trial, to perform their tasks… data entry and query management quickly and efficiently. This Requires:
- Previous problem areas of the study must be identified and eradicated or improved
- Rapid set up of the new eCRF/database
- Facility to import existing study data quickly and efficiently whilst maintaining required integrity and audit trails
- EDC flexibility with regard to future protocol amendments when a study is ‘live’
The impact of Coronavirus not only creates a need for rescue trials but it seriously impacts on the traditional methods to deliver them. If you have to consider the potential difficulties of data collection you also now need to look at options to:
- collect data remotely and consider facilities such as eConsent and subject-led data entry via ePRO or eDiary modules.
- cater for unscheduled visits
CRFWEB – Everything You Need To Initiate A Rescue Study In The Current Environment:
- Set up in days
- Data import facilities
- DDC and subject-led data entry via the CRFWEB App
We are currently have a special offer on ePRO/eDiary to help you get started
Contact the team to see how we can help rescue your trial.