Cancer patients have had to wait longer for innovative new cancer drugs than more traditional treatments, suggesting that the most exciting new treatments have not been successfully tracked, statistics show.

Researchers have found that the higher the level of innovative cancer drugs, the longer it takes to pass clinical trials, license and assess availability in the NHS.

Statistics show that new therapies and drugs for cancer must undergo more and more trials before they reach the final consumer, who may not have enough time to wait..

A team from the Institute for Cancer Research in London conducted an analysis in preparation for their new cancer drug discovery center to help make the case for more streamlined rules for the most exciting treatments..

New innovative therapies are designed to tackle the new weaknesses of cancer and form a key part of the Institute for Cancer Research (ICR) strategy to overcome the lethal ability of cancer to develop treatment resistance.

The study was published in Drug Discovery Today and provides an overview of access to all medicines licensed through the European Medicines Agency (EMA) from 2000 to the end of 2016..

Researchers assigned each drug to one of three innovation categories—high, medium, or low—with a high innovation category, including drugs with a new target or mechanism of action, or representing a new class of treatment in an area of \u200b\u200bunmet need..

The most innovative cancer drugs took 3.2 years longer from patent filing to NHS patients than the least innovative treatments, indicating that various initiatives to prioritize the most innovative drugs have not yet been effective..

Researchers call for action to improve patient access to the most exciting new therapies by streamlining clinical trial and licensing rules and stronger incentives for innovation in drug discovery and development.

Between 2000 and the end of 2016, it took 14.3 years for the most innovative new medicines to move from patenting to availability on the NHS—compared to 13.5 years for drugs with moderate innovation and 11.1 years for the least innovative treatments.

Most of the delay appears to have occurred between the start of Phase I and EMA approval, which lasted an average of 8.9 years for the most innovative drugs compared to 8.7 years for moderately innovative drugs and 6.8 years for the least effective..

Among the highly innovative drugs facing delays, mifamurtide took 20 years to go from patent through trials and licensing to NICE approval for osteosarcoma, and traberectin took 22 years from patent to NICE approval for advanced soft tissue carcinoma.. Most recently, the EMA only authorized the use of olaparib for breast cancer in April 2019, 15 months after the U.S. Food and Drug Administration, and NICE still hasn't released its assessment..

The average number of drugs subject to EMA licensing increased from a median of six per year from 2000 to 2008 to 13.5 per year from 2009-16. But the average time from filing a drug patent to submitting it to the NHS increased over the study period, from 12.8 years for drugs first licensed between 2000 and 2008 to 14.0 years for drugs licensed between 2009 and 2016..

Time taken from filing a patent to create a phase I trial increased from a median of two years for those licensed from 2000 to 2008 to three years for those licensed from 2009 to 2016.

As with the approval delays seen with the most innovative new drugs, there appear to have been delays between the start of a phase I trial and EMA approval, lasting an average of 7.7 years for drugs first licensed since 2000..

The researchers found that NICE reduced the delay time between EMA authorization and its initial technology assessments, from an average of 21 months for drugs first licensed between 2000 and 2008 to 6.5 months for drugs licensed between 2009 and 2016.. no faster in conducting their assessments, which took 16.7 months from 2000 to 2008 and 16.0 months from 2009-16.

There is evidence that NICE did not prioritize the most innovative treatments: only 38 percent of highly innovative cancer drugs received a favorable recommendation at the time of analysis, while 53 percent of drugs were classified as moderately innovative..

However, this difference seems to be due to the fact that NICE was less likely to start evaluating more innovative drugs and has since committed to evaluating all new cancer drugs, which should eliminate the discrepancy..

Overall, the results show that there is a need to create stronger incentives across drug discovery and development to encourage companies to come up with innovative new therapies that can deliver significant patient benefits..

The study raises particular concerns about the regulation of clinical trials and drug licensing in the UK and Europe, and suggests that the Medicines and Health Products Regulatory Agency (MHRA) and the EMA should adapt their regulatory approaches to facilitate the adoption of exciting new practices.. patients.

The study is published and ICR now needs to raise at least ?10 million for its new ?75 million Cancer Drug Discovery Center which will feature? the world's first anti-drug program dedicated to fighting cancer and drug resistance.

Study leader Professor Paul Workman, Executive Director of the Institute for Cancer Research in London, said:.

“Our study details the major advances made in the fight against cancer: the average number of licensed drugs has more than doubled annually over the past decade. But it is also clear that our regulatory systems are not keeping up with science.. it takes longer for new drugs to reach patients and, alarmingly, delays are the longest for the most exciting, innovative therapies, with the greatest potential to change patients' lives.

Currently, the entire ecosystem for drug discovery and development, including regulators, researchers and companies, is too risk-averse. It is critical that academic researchers and pharmaceutical companies feel that regulatory systems for drug development support risk taking and innovation, rather than discouraging it by slowing it down.. Our study raises questions in particular about UK and European clinical trial and licensing processes that should better recognize and encourage innovation..

As ICR launches an exciting new “Darwin drug discovery program to combat cancer development and drug resistance, we are calling on government, regulators and industry to work together to reshape the cancer therapy ecosystem as new and improved cancer treatments could save millions of lives.”.

medical-heal. en.