It has long been a goal of the clinical trials industry to tackle two of its standout issues — time and cost.
The Tufts Centre for the Study of Drug Development estimates a total cost for the development of a new drug at $2.6 billion; however, new research, conducted by Tufts and supported by Medable, has demonstrated for the first time an actual quantifiable financial benefit to using Decentralised Clinical Trials.
Factoring in the key elements of cost, time, revenue and risk, actual prior industry data was analysed with some extremely interesting results:
The study found that using decentralised technologies led to shorter development cycle times — good news for an industry where 85% of clinical trials will experience some sort of delay, costing developers up to $8 million per day. For example, Phase 3 trials studied were on average seven days faster with decentralised components, leading to a total trial duration time decrease of just shy of a full year.
Retention and Diversity
Retention is always a practical problem in clinical trials as is diversity. Wearable devices and use of mobile apps was found to decrease dropout rates from 28.6% to 26.1% enabling faster screening, more convenient consent and enrollment, increased diversity and the elimination of long travelling times to trial centres.
Fewer Protocol Amendments
Protocol Amendments are recognised as a significant cause of delay in trials which, of course, drives up cost and time. In decentralised trials, Tufts found a decrease in the mean number of amendments from 3.4 to 3.3.
All of the factors involved resulted in trial cost savings being reported. However, initial outlay in implementing the technologies for a decentralised trial is still a serious consideration when all of the relevant components such as home visits, telehealth, apps, devices and assessments are factored in.
However, the benefits outweigh the costs, according to Tufts with cycle reduction times of 20% over six months reported, and a return on a $3.126 million investment (for an average of three Phase 2 trials) to be between $17.3 and $77.8 million
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