The pay-off for reducing cycle time in medical device clinical trials

Well – it certainly isn’t science and technology innovation or even the FDA.At a recent executive roundtable, according to Tufts University’s Center for the Study of Drug Development director and associate professor Ken Getz, it is that many pharma corporations and CROs have not yet fully embraced the newest, most efficient technologies, and this has been a huge problem in recent years.

More expensive. Riskier than ever.

“Drug development cycle times have not gotten faster, costs continue to increase, and drug development has become riskier than ever with only 11.8% of products that enter clinical testing receiving regulatory approval, about half the rate of the 1990s,” says Getz.

Which, of course, is true, as we in the clinical trial industry know that it takes about a decade for a drug to be developed and on average seven years for it to be tested before it makes it to market, and only if it gains regulatory approval. So, what would happen if clinical testing time could be shortened?

Getz continues, “The pay-off for companies that can reduce clinical time and cost is potentially large, as our research has found, for example, that a 10% improvement in cycle time and success rates can shave $634 million off the total capitalized cost of $2.6 billion required, on average, to bring a new drug to market.”

What was one of the primary answers to solving the problems of costs and inefficiency? Incorporating mobile devices to use cloud EDC in place of paper for clinical studies.

As seen below, cloud computing and mobile device integration help organizations grow significantly faster than if not incorporated into the operational procedures.

Implementing EDC has been gaining traction among many CROs for the past decade plus, in place of paper or a paper-EDC hybrid. Why? Well, as seen in this infographic, it saves an enormous amount of study time during every phase of medical device clinical trial. While the vast majority of clinical trials use EDC (50% of FDA studies; 80% of non-FDA studies), many are still using on-site installation of software and hardware for their electronic data capture.

This all being said, there are tremendous advantages that cloud EDC wields over on-site EDC systems, which saves even more time and costs, while still providing the decrease in errors, query reduction, and savings on long-term costs that traditional EDC has been prized for in the clinical trial industry. Cloud EDC is the future of clinical studies, so today we are going to touch upon how it has been transforming the entire industry, saving study sponsors precious time and money in an overwhelming costly industry.

Trials are are expected to be completed in less time

As we mentioned, and as many of you know, medical device clinical trials are far from completed in a matter of weeks. Even Phase I of a clinical trial will typically take several months. However, cloud EDC saves pharma and CROs trial time throughout each phase for a few different reasons.

First, cloud EDC has the advantage of the swiftest set-up time to prep for commencing a trial. Lengthy startup times have typically plagued the industry, but cloud EDC alleviates many of the headaches inherent with paper-based, hybrid, or even on-site EDC. Because the cloud provides a single repository for data storage, eCRF templates, etc. there is no need for sponsors to spend time on installing hardware on site or ordering and organizing materials needed for a paper based study. Further, during study planning and progress reports, there is no need for in-person meetings as all information is shared online, so communication between multiple study sites is without any geographic hinderance.

For successive studies that are repetitive in nature, eCRFs are stored in the cloud and can be accessed with a single click which, eliminates the time needed to design a new CRF from the ground up. Also, because data is entered in real-time and can be done such using mobile devices, monitors get data into their hands instantaneously and do not need to spend time travelling to and from study sites.

Elasticity of growth – more users, sites and data without changing your system

To follow up on the previous point, due to the lack of a need for on-site installation of hardware or physical materials (besides mobile devices), adding additional sites to a study happen in less time than any other method for data capture. This is especially valuable for studies expanding to new geographic territories, such as a new country in a different continent. As soon as a new site logs into the cloud EDC they have access to all of the data and compliance regulations needed to get the new site up and running.

Paperwork is not just reduced, it is practically eliminated. On both the technical end and business end, pharma and CROs can expand the scale of medical device clinical trials without the headache of filing documents or procuring and installing materials and hardware, facilitating growth.

Sponsors have more options than ever before

Now that cloud EDC is no longer first-generation technology, there is greater competition, and thus a greater number of options for sponsors to choose from. Whether a startup CRO or a multi-billion dollar pharma titan, there is now a cloud EDC vendor to suit any sponsor’s needs, and at very competitive price points.

Consider the following: in a recent report, the cloud EDC industry is projected to grow from $3.73 billion in 2015 to $9.48 billion by 2020. In only five years the entire industry will have well over doubled in size. To further underscore the rapid increase in the number of cloud EDC options for sponsors, in another study, in 2013 50% of the cloud EDC market was shared by only two providers, and in 2015 that 50% market shared was shared by five providers.

 

The cloud-based healthcare provider industry is paced to grow at an average of 14% through at least 2020, which means year after year sponsors will have more options to choose from at lower price points, which will soon give no cause to continue with paper, hybrid, or on-site installed EDC systems.

 It isn’t a trend – it’s a revolution

In every way, and for the better, the proliferation of cloud EDC is removing much of what had become the clinical trial status quo: time intensive, inefficient, and cumbersome communication channels. Not only does implementing EDC save many sponsors time and money, but it allows for more rapid growth in study scale when needed or desired. We are happy to see that EDC has taken to the cloud so effortlessly, as it makes a historically difficult series of processes infinitely less tiring, easily organized, and flexible.