It cost an average of $19 million to get new drugs through their pivotal clinical trials and onto the market, a new analysis has found.
Researchers at the Institute for Safe Medication Practices and Johns Hopkins University reviewed 59 separate drugs or therapies approved between 2015 and 2016 and analyzed their costs based on estimates from IQVIA software. In what may be the first study of its kind, they found costs varied widely, from $12 million to $33 million per trial. A glaring exception: cardiovascular drug trials, which averaged more than $157 million.
The FDA late last week issued two new draft guidances — one on adaptive clinical trials and the other on master protocol designs — that it hopes will help sponsors innovate and get treatments to market more swiftly and efficiently.
“The standard approaptive clinical trials can give sponsors the flexibility to react to clinical evidence as it’s being collected, and modify the design and enrollment in trials by including more patients ch to generating evidence — a series of clinical trials, each investigating one or two interventions in a single disease — has become more expensive and challenging to execute,” FDA Commissioner Scott Gottlieb said in announcing the guidances.
Decentralized clinical trials offer a chance to expand patient pools, obtain more data and — ultimately — move medicines and treatments to market faster. But sponsors worried about risks behind the technology driving decentralization don’t have to completely abandon traditional trials, according to CTTI.
“There is a broad continuum of hybrid approaches that provide sponsors and CROs with varying opportunities to implement decentralized trials, even if it is their first time doing so,” the group says in new recommendations urging drug developers to absorb fresh technologies into trials.
Researchers who fail to file trial data with ClinicalTrials.gov on time could be fined up to $10,000 per violation—and the FDA says it will aggressively pursue those penalties. Read More
When Apple introduced the latest iteration of its Apple Watch earlier this month, it was hailed by an unlikely source: FDA Commissioner Scott Gottlieb. Read More
Drugs targeting the central nervous system take significantly longer to develop and get approved than other meds, according to a new analysis. Read More
Earlier this year, Swiss-based pharma giant Novartis began an ambitious transition that company leaders say will ultimately change it from a drug maker to a data management company. Read More
The FDA has issued new guidance for clinical trials testing drugs designed to treat hay fever as well as sniffles and other cold-like symptoms that aren’t caused by allergies. Read More
Master protocol designs have taken on new significance as sponsors, sites and regulators have come to recognize that decision points must be reached sooner—and the FDA is planning to issue new guidance on them in the coming weeks. Read More
WCG has partnered with Inspire, a leading online health social network, in an effort to make it easier for patients—especially those with rare and genetic-based diseases—to find clinical trials that may help them. Read More