Only 12% of companies reporting R2 readiness
In June this year we conducted an industry survey on ICH E6 (R2) readiness, and had over 100 responses. Only 12 % said they have completed their readiness programs. Even more surprising, 27% of respondents said they haven’t even started yet.
Given the adoption of R2 by EMA, FDA and Health Canada during 2017 /18 this high number came as a surprise. We decided to investigate further to try and understand the blockers to readiness.
Lack of time, budget and leadership support were significant reasons cited by almost 40% of respondents. Over 30% said they didn’t know what ‘finished’ looked like. But perhaps most worryingly, 15% said they didn’t fully understand the requirements in the first place.
In a separate question about performing risk assessments on trial protocols, only 18% said that risk assessments were conducted on all their trials. 40% said that risk assessments were applied to some protocols, but a massive 42% said that risk assessments were applied to none of the protocols in their company. Again, we investigated the reasons and found almost 40% cited lack of understanding and training as their primary blocker.
Whilst the sample size is relatively small, we have seen similar results in other surveys and industry events and believe them to be representative. These findings have big implications for the sector. There is clearly a significant need for more awareness and better training to get the R2 compliance journey started, but perhaps more importantly, it is the application and implementation of R2 practices and technology where companies need the most support. Having a trusted partner who is able to provide solid advice, guidance and support, but who also has the experience to deliver training, processes and technology is key to moving your company forward.
TRI is dedicated to helping companies achieve compliance and then run trials in a fully R2 compliant manner. Whatever your stage in the compliance process, and whatever level of support you might need, we are confident we can help.
To find out more about how TRI can accelerate your R2 journey, contact us now at firstname.lastname@example.org.