Five critical elements required to deliver successful decentralised trials
The pandemic marked the advent of virtual trials. But adapting to the new normal requires a wider understanding of the challenges in clinical trial decentralisation, as well as the opportunities they represent to patients and sponsors alike.
In the latest edition of PharmaTimes Professor Yan Yanniakou, Chief Investigator of the UKs first fully virtual trial and Clinical Director of NIHR Patient Recruitment Centre: Newcastle, examines the evolving clinical trials landscape and highlights some of the key considerations for anyone planning to run a decentralised clinical trial (DCT).
The critical elements required for successful DCTs
1. Far reaching recruitment
DCTs span geographical boundaries, therefore effective recruitment methods are necessary to achieve the same geographical reach. Opportunities may include ‘consent for contact’ registries, digital media advertising and ‘big data’ solutions.
2. Robust screening capabilities
Direct-to-patient recruitment methods lead to high volumes of poorly characterised respondents. A robust screening platform or linkage to electronic health records is a game-changer.
3. Consent to contact
Obtaining prior consent to contact potential participants is another key challenge, bearing in mind that response rates may be low where invitations are unsolicited and come from an unfamiliar source.
4. Patient-friendly language
Direct-to-patient recruitment methods also need to ensure the language is simple and unambiguous for potential participants. Messaging needs to be informative and include considerate advice for respondents who have taken the time to volunteer and may be disappointed to learn they are not eligible.
5. Remote monitoring and care
This area continues to rapidly develop including: drug/device delivery; home-based GCP-certified nursing; monitoring via wearable technology and app-based data capture; participant confidence to self-administer some drugs and tests. But how do we approach would-be participants who feel uncomfortable with staff entering their home? How does a principal investigator (PI) retain oversight of staff he/she has never met? How does a PI facilitate remote management of adverse reactions?
Read the full article for a more in depth analysis of the critical elements needed to run successful decentralised trials.