A Personal Perspective on Clinical Trials18 May 2025 18:32
As it happens I have just been invited to take part in a Phase 3 clinical trial of a new drug. This is giving me first hand experience of the time involved and the effort that goes into each phase before the drug is approved. Some of you may already have taken part in clinical trials perhaps even this one. For those of you who haven’t, I thought this insight might be instructive in appreciating the extensive timescales.
In November 2018 a Phase 1 trial was started with the intention to compare Xxxxxxx to placebo in 100 healthy adults
In July 2020 a separate Phase 1 study was started with thirty participants with clinically diagnosed conditions of the condition that the drug will cure.
In 2021, the company added a second part to this trial, enrolling an additional 32 healthy adults.
Through 2021 and 2022, enrollment was adjusted upward twice to a final of 224, the treatment period increased to 61 weeks, and the study added subcutaneous dosing. Conducted at 10 U.S. sites and three in Japan, the trial ran until November 2024.
The Phase 3 trial plans to enroll 1,200 participants worldwide for 18 months of home treatment with subcutaneous injections, followed by a blinded observation period, against a primary endpoint of time to progression.
The trial will last about 5 years and comprise:
1. the screening period of about 17 weeks depending on your personal health care situation
2. the treatment period of about 78 weeks
3. the observation period of about 3 years
4. the follow-up period of about 20 weeks
So in 2031 they may get approval for this drug. That is 13 years from the start of the first phase 1 clinical trial. And you all think that Avacta is slow. I won’t bore you with the screening process which is arduous.
I am not saying AVA6000 will take 13 years in total but I am starting on a personal experience which will give me a far better understanding of the time involved.