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How can Embrace2 for Research help in alleviating clinical trial costs?

It’s a known fact - the costs of conducting clinical trials are very high. In a 2016 study, it was estimated that the average pre-approval costs per new compound were $2.6 billion. The estimate increases to $2.9 billion post-approval [1]. Researchers have argued that these “rising clinical costs have made the industry as a whole more risk-averse and less willing to take chances on novel medicines.” [2]

Not only are clinical trials costly, but their completion times are also long. According to DiMasi et. al, mean phase lengths are 21.6 months (1.8 years) for Phase 1, 25.7 months (2.1 years) for Phase 2, and 30.5 months (2.5 years) for Phase 3. The period between completion of Phase 3 and drug approval typically lasts one to two years, including six to 10 months for the New Drug Application (NDA) review itself, or even more if the drug is not approved after the first review. In short, the estimated mean completion time from Phase 1 until the release of a drug can take up to 7.4 years.

Furthermore, a 2006 study showed that a drug’s cycle times in development and regulatory approval are increasing. This means that a new drug can take even longer to go to market.[3] In addition to longer labor and running costs, DiMasi et. al. estimated that “roughly half of the total cost of bringing a new drug to market was due to opportunity costs associated with foregone investments over the drug development period.”[1]

Numerous factors may affect clinical trial expenditures, but some of the primary drivers in costs include [4]:

  • Clinical procedure costs (15%-22% of total)
  • Administrative staff costs (11%-29% of total)
  • Site monitoring costs (9%-14% of total)

Fortunately, a wide array of tools and strategies are also available to help mitigate the barriers that researchers face. While there is no single solution, we hope we can provide you with information on the potential cost-cutting benefits of using the Embrace2 for Research remote trial management platform.

How can our system help?

Some of the more effective tools in which Embrace2 for Research can potentially contribute to the alleviation of clinical trials costs include [5]:

  • Wider use of mobile technologies, including electronic data capture (EDC)
  • Simplified clinical trial protocols
  • Use of lower-cost facilities or at-home testings

Mobile technology and electronic data capture (EDC)

The use of mobile technologies is one of the most effective and acknowledged approaches to reducing clinical trial costs. A report by the United States Department of Health and Human Services calculated that it saves about $0.4 million (up to eight percent of the cost per study) in Phase 1, ~$2.4 million (up to 12 percent of the cost per study) in Phase 2, ~$6.1 million (up to 12 percent of the cost per study) in Phase 3, and ~$6.7 million (up to 13 percent of the cost per study) in Phase 4.[5]

A key aspect of the use of mobile technology in clinical trials is the replacement of paper diaries with an Electronic Data Capture (EDC) system. Using EDC, researchers can collect and enter data into a data collection tool only once. With a paper system, on the other hand, data would have to be entered first into a case report form, then into an electronic system by a data entry group. Not only does this increases processing time, but transcription integrity is also affected.

The adoption of EDC has been examined in various publications with some profound results:

  • 30% decline in study duration. [6]
  • Saving throughout all the phases of clinical trials. More or less 5% in every phase and 10% in phase 4. [5]
  • The cost of a whole clinical trial can potentially be reduced up to 9.8%. [7]

Embrace2 for Research as an EDC system

Our Embrace2 for Research ecosystem allows subjects to use our mobile technology and the adoption of an effective EDA system. Some of the direct costs that can be saved with Embrace2 for Research include but are not limited to [6]:

  • Double data entry per page
  • Data entry labor by technician
  • Data cleaning costs
  • Printing and mailing each page
  • Storing and archiving paper
  • Fewer queries and faster resolution

The system streamlines the collection and transmission of clinical trial data directly from the patient to the researcher. Our FDA-cleared Embrace2 guarantees clinical quality data, subject use of the Mate App automates the data flow, and the Research Portal allows real-time data monitoring and exporting.


Based on the current literature, we inferred the cost-saving factors of Embrace2 for Research as an EDC system. A possible estimation of how much a pharmaceutical company can save per patient are the following:

  • Phase 1: $367 per patient
  • Phase 2: $2900 per patient
  • Phase 3: $4860 per patient
  • Phase 4: $702 per patient

Use of lower-cost facilities or at-home testings

Costly infrastructure and overhead can be reduced by utilizing lower-cost facilities, such as local clinics and pharmacies, for data collection purposes. Local centers may also be used to conduct follow-up visits, minimizing travel and time costs for participants, and thereby possibly improving retention.

However, due to the current COVID-19 disease outbreak, clinical trials around the world face different challenges as various restrictions and quarantines are implemented in an effort to prevent the further spread of the virus. More relevant now than ever, having the option for patients to participate remotely in the comforts of their own home not only prevents site travel costs, but is recommended to assure the safety of trial participants.

FDA recently issued the COVID-19 GCP Guidance Document, which provides helpful recommendations and guidelines for clinical trial entities, given the pandemic and its immediate impact on ongoing and planned trials. One of the considerations is to optimize the use of central and remote monitoring programs to maintain oversight of clinical sites.

Running multi-site remote trials with Embrace2 for Research

A web-based platform that shows real-time data feedback, the Research Portal allows researchers to not only set up the study online, but also to continuously monitor participants’ compliance in a remote setting. Using our platform as a remote trial management tool is a cost-effective, reliable, and particularly relevant option during this time.

  • Minimizing site visits lead to fewer travel costs, less physician-administered procedures, and less physical data entry.
  • Reduce the Hawthorne (observer expectancy) trial effect.
  • Embrace2 is less expensive than most other data collection instruments.
  • Subjects wear a comfortable and minimal watch that is non-invasive and easy to use.
  • All of this improves the overall experience for the patient, thereby improving patient retention and compliance.

Simplified clinical trial protocols

According to a recent study conducted by Tufts CSDD, “22.3 % of all procedures are considered to be non-core and can be considered “extraneous”[8]. Based on this information, the clinical procedure total (per patient) was also reduced by 22.3 percent in all phases.

These extraneous costs are associated with the collection of unnecessary data and the implementation of avoidable protocol amendments. Getz estimated that “approximately 15 to 30 percent of all clinical data collected is never used in NDA submissions, costing an additional $20 to $35 million in direct drug development costs for the average drug” [9]. By collecting less but pertinent data, budgets can be focused on what matters.

Embrace2 for Research to simplify protocols

Aside from facilitating easy data collection, Embrace2 for Research can ease certain procedures to avoid extraneous and additional work:

  • Availability to pre-enroll subjects remotely and prior to any site visits may help shorten study timelines.
  • The Research Portal allows researchers to reduce the hassle of complex setup by doing many steps virtually.
  • There is no need for technical experts every step of the way. Data entry labor and data cleaning costs can be reduced since the data is collected automatically and available to download online.

In addition to these benefits for researchers, simplified clinical trial protocols may make it easier to recruit and retain patients by making trial participation less burdensome and exhausting. [5]

Conclusion

There is no single strategy that can provide a solution to the increasing costs of clinical trials. Nevertheless, implementing technological and operational measures that can enable better and faster data collection, remote study management and the simplification of otherwise complex processes, has great potential in the alleviation of clinical trial costs. Talk to our team to find out more about what Embrace2 for Research can do for you and your team.

Sources

  1. DiMasi, Joseph A., Henry G.Grabowski, and Ronald W.Hansen. Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics (2016): 20-33.
  2. Roger Collier. Rapidly rising clinical trial costs worry researchers. 2009.
  3. Kenneth A. Getz. Hitching a ride with the speed demons of drug development. _Appl Clin Trials (_2006);15(12):22-24.
  4. Aylin Sertkaya, Wong, HH, Jessup, A, Beleche, T. Key cost drivers of pharmaceutical clinical trials in the United States. 2016.
  5. Examination of Clinical Trial Costs and Barriers for Drug Development, HHS. 2014.
  6. Neuer, Warnock, and Slezinger. The Upfront Cost Hurdle of EDC. Applied Clinical Trials. 1 April 2010.
  7. Eisenstein EL, Collins R, Cracknell BS, Podesta O, Reid ED, Sandercock P, Shakhov Y, Terrin ML, Sellers MA, Califf RM, Granger CB, and Diaz R. Sensible approaches for reducing clinical trial costs. 2008.
  8. Tufts CSDD. One in Five Procedures Generates Extraneous Clinical Trials Data. November/December 2012, Vol. 14 No. 6.
  9. Kenneth A. Getz. With clinical data, less is more. Applied Clinical Trials. 2010;19(1):28-30.

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Embrace is currently available only in English. Embrace is an investigational device in the USA and a medical device in the EU. If you do not see your country listed, please visit the International site.
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