Slashing the cost of clinical trials
It is a truth universally acknowledged that in this tough payer climate, pharma must slash costs. Software companies offer opportunities to streamline the clinical trial process from design to analysis, promising to save the industry at least US$3.7billion across phase II and phase III trials.
According to a whitepaper by software company Medidata, 10 years ago clinical trials enrolled 1,400 patients across an average of 67 sites, costing US$86.3 million, lasting about 2.5 years, with a 70% chance of bringing a new drug to the market. Nowadays, trials involve over double the number of participants across over 100 sites, costing about three times as much over 2.5 years, but with only 50-60% probability of the drug getting approval.
Surprisingly, up to 30% of the data collected by industry sponsors (estimated to cost US$1 million) is never used in an FDA application, and 25% of all procedures are not associated with any of the key endpoints. This inflates the costs of a trial in two ways. Firstly, there are operational costs associated with undertaking all those procedures. Secondly, there are challenges associated with patient recruitment and retention, as patients are reluctant to participate in trials that pose a significant burden to them.
This suggests that the future of pharma depends not only on scientific innovation, but also on operational innovation that should go hand-in-hand with medical breakthroughs. Life science organizations spend US$90 billion per year on clinical development, out of which only US$2 billion is spent on trial technology. If the two billion were to be appropriately leveraged, it would have a substantial impact on the US$51 billion spent on processes and operations, leading to significant savings.
Driving down cost
Medidata’s approach is about optimizing the development process to enable operational innovation. They aim to make the most effective use of the clinical trial process by “supporting the entire clinical research workflow rather than focusing on discrete activities, automating inefficient processes, and shifting bottlenecks", reads a statement on their website. Medidata claim to be able to identify and eliminate non-value and redundant tasks; gain line of sight from procedure to protocol, to study, and to the entire portfolio; and enhance collaboration and decision-making. How do they do this?
When they looked at the benchmark information that we provide, they realized that six was more than would typically be done for that type of trial. They were then able to discuss that finding with the sponsor company, in the end reducing the number of mammograms from six to two, reducing the cost, and providing direct patient benefit".
“We provide software, which we host in our cloud facilities, allowing users to log in through their web browser to make use of it for trial design, through recruitment, collecting and managing data, to making sure that the data is clean and ready for analysis and submission to the regulatory authorities", Andrew Newbigging from Medidata explained.
How does it translate into savings? One way is by optimizing study design so that all protocols are aligned with the study goals, thereby eliminating activities that do not support endpoints. To achieve that, a client can use a tool that provides information on cost and frequency of individual procedure usage to help trial planners see the impact of different protocol designs on patient enrollment, trial cost, and timeline.
Newbigging elucidates: “[Our tool] allows our customers to look at how they’re designing the trial, and to benchmark what they’re doing against a large database of other studies. For example, when one of our partners looked at a study in our software, they found that the sponsor was planning to do six mammograms on each participant in the trial. When they looked at the benchmark information that we provide, they realized that six was more than would typically be done for that type of trial. They were then able to discuss that finding with the sponsor company, in the end reducing the number of mammograms from six to two, reducing the cost, and providing direct patient benefit.”
Speeding up trials
Seventy percent of trials experience delays that stretch for over a month, costing the sponsors US$1 million per day in unrecognized revenue. Most often delays are related to problems with recruitment. Only one in four screened patients complete the trial, while 25% of all sites don’t ever enroll a single patient.
Medidata is looking into how to solve that problem, too. “We’re looking for ways to make use of the data that it now in our repositories to identify which clinical sites have been more effective with recruitment, so when sponsors are trying to identify places to set up sites for new trials, we can provide them with the information they need,” Newbigging said.
In addition to that, there is an instrument that analyzes cross-site and cross-study key performance indicators. It offers a set of tools that allows for the optimization of timelines, resource allocation, expenditures and site performance during the execution of clinical trials.
With increasing pressures on drug development, where for every dollar put in, sponsors get 75 cents back, the need to be more effective is greater than ever. In times of big data, this means finding a way to deal with continuous measurement of vital signs collected from the patient second by second.
“That [continuous data collection] is on a much bigger scale than what we had in clinical research before. We need to make sure that our software is designed to cope with those volumes. In my teams, we’re looking at the cutting edge of big data systems. We adopt approaches used by Amazon and Netflix, and we do what we can for our systems to be advanced enough to deal with that data,” Newbigging said.
The future also requires savvy data integration. “Linking with other sources of data is a very important new development. We’re exploring linking to healthcare providers – we think there’s value in connecting data collected in trials with the data generated in the clinical treatment phase to start looking for trends. By combining those, we get much richer data sets", Newbigging explained.
A trial usually has inclusion and exclusion criteria, so there is a narrow range of people the drug is being tested on, but when the drug is being prescribed, it reaches a much broader range of people. “So by combining those data sets we can see whether the drug works on people it hasn’t been originally tested on", Newbigging concluded.
The cost of clinical trials, currently estimated at over US$86 million, has skyrocketed over the last decade, and, if it is to survive, the industry must find ways to control it. Software companies offer opportunities to slash those costs. Those opportunities are not to be missed, as the future of the industry depends on operational innovation that must go hand-in-hand with medical breakthroughs.
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