Stakeholders are being asked to help shape new guidance that
outlines how greater use of real world data in clinical trials
could help transform the availability of cost-effective
treatments. The innovative use of real world data can help to
bring life-changing new medicines to those who need them sooner,
says the Medicines and Healthcare products Regulatory Agency
(MHRA), who launched a consultation on the guidance today.
Vast amounts of data are routinely collected from patients using
the healthcare system. This includes electronic patient health
records, and disease and patient registries.
While the information generated by real world data is frequently
used to monitor the safety of medicines and medical devices after
they have gained approval, it is rarely used to help demonstrate
the effectiveness of an intervention before it is approved.
MHRA Director of Licensing, Dr Siu Ping Lam said:
“When used in this innovative way, real world data has the
potential to make a huge difference when it comes to bringing
medicines from clinical trials to patients.
“With fewer or no trial-specific visits, consenting trial
participants don’t have to travel long distances to get to their
appointments. And with fewer logistical hurdles, real world data
could make it more feasible for trial sponsors to repurpose
existing medicines for new conditions – with the potential to
save the NHS millions of pounds.
“Because of this, and the growing need to find more
cost-effective ways of conducting clinical trials, our new draft
guidance focuses on how to use real world data to gain regulatory
approval, helping to bring medicines to the patients who need
them, sooner. We look forward to hearing people's thoughts.”
Read the
draft guidance and provide your feedback by 11 December 2020.
