Challenges and Lessons Learnt Learned from Industry-Driven Multi-Centre Global Clinical Trials in IgA Nephropathy (IgAN): Site Investigators' Perspective
Glomerular Diseases: Translational Studies and Biomarkers
November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
1402 Glomerular Diseases: Clinical, Outcomes, and Trials
Mani, Selvin Sundar Raj, Christian Medical College Vellore, Vellore, Tamil Nadu, India
Alexander, Suceena, Christian Medical College Vellore, Vellore, Tamil Nadu, India
IgA nephropathy (IgAN) is the most common glomerulonephritis worldwide. Recently, many promising bio-molecules are being studied in clinical trials which are industry sponsored, multi-centre and global. Does the uniform protocol across the centers really reflect the regional practices or standard of care in a geographically varied disease like IgAN?
This was the site investigators’ perspective after being involved in 5 ongoing industry driven phase 2/3/OLE multi-centre clinical trials in IgAN. More than 20 eligible patients were enrolled from one of the largest not-for profit quaternary medical centre in South India over a span of 3 years. We are highlighting some of the best practices and some of the regional challenges for participants.
Consent process- The entire process of providing trial related information, informal consultations with relatives and family doctors before providing an informed written consent could take 3-4 months. The strength of this long-drawn pre-consenting phase is improved overall retention and minimal drop-outs.
Screening phase- In India, it is common to test positive for latent tuberculosis using IGRA tests due to community exposure. This is one of the major impediments for recruitment as otherwise they would have received immunosuppression in the absence of active disease. Another major road block was the anti-hepatitis B core antigen testing in the absence of hepatitis B surface antigen or hepatitis B viral DNA positivity.
Recruitment and Retention phase- Flexible appointment times, frequent reminders and good rapport with the clinical trial team gained the participants’ trust and helped in retention. Reimbursement of actual expenses is vital to ensure proper visits and compliance to treatment. Investigators meetings and regular newsletters helped us to track recruitment and SAEs at a global scale.
Post trial access- Indian regulatory approval for open label extension is long drawn which has directly affected the post-trial access to potentially valuable bio-molecules for participants in phase 2/3 clinical trials.
Industry driven global clinical trials are indispensable but sponsors could consider some regional modifications in the entry criteria and post-trial access. This also highlights the need for academic trials that repurpose the already available molecules.