Drugs companies could save an average of $283 million for each successful new product launch if they were to use a forecasting model that weeds out experimental medicines that are destined to fail, it was claimed yesterday.
Use of the system, the Children’s Hospital Boston Informatics Program (CHIP), would also boost revenues by an average of $160 million per Phase III trial, its creators say, by ensuring that fewer drugs were withdrawn from the market soon after their launch.
CHIP researchers led by Dr Asher Schachter and Dr Marco Ramoni constructed the model, based on Bayesian statistics, to calculate the probability that a given new drug would pass successfully through Phase III trials and receive FDA approval.
“By using this system, pharmaceutical companies could focus on the drugs that are likely to work – and this could help address the lack of blockbusters we’ve seen in recent years,” he told Pharma Times.
The researchers studied publicly-available safety and efficacy data for about 500 successful and failed new drugs, broken down by therapeutic category. They then confirmed the validity of their model by testing it with a group of cancer drugs whose fates were already known.
To gauge the model’s potential financial impact, Dr Schachter collaborated with researchers at the MIT Sloan School of Management. In their report in Nature Reviews Drug Discovery, Dr Schachter and Dr Ramoni argue that more accurate clinical forecasting would eliminate unsafe investigational new drugs; avoid patients being subjected to unnecessary drug trials; reduce the cost of prescription drugs for consumers; and allow the industry to take risks on truly innovative new drugs, so that more get to market.
And he added: “This system might stop some drugs that could turn out to be very useful from being terminated too early.”
Dr Schachter, who is also a paediatric nephrologist at Children’s Hospital Boston, said that more data sharing by the pharmaceutical industry would also enable the industry to learn more from its own failures.
“There’s a tendency in the industry to bury data on failed drugs and forget about them,” Dr Schachter says. “We hope our model will add fuel to efforts to show that data-sharing could be beneficial to everybody.”
Such efforts include legislation introduced in the Senate last year (S3807) that would establish a clinical trial registry database that would report the results of later-stage studies, both good and bad.
The need for pharmaceutical industry involvement in early trials is especially acute for pediatric drugs, Dr Schachter added. He said companies were reluctant to conduct clinical trials in children, for fear of negative publicity. Instead, doctors often resort to giving adult drugs to children off-label, outside the context of a controlled, safety-monitored study. Michael Day
