Integration of technology-backed platforms with mobile services that benefit clinical research initiatives are helping to catalyze the adoption of decentralized clinical trials and emphasize the value of remote trial accessibility.
The cost of clinical trial operations has steadily grown over the past few decades . Oversight costs for clinical studies are outrageously high and significantly impact on new, life-changing products being brought to market. The most widely accepted all-inclusive cost estimate of developing and bringing a new drug to market places the high-end cost at $2.8 billion . Phase 1 drug trial costs are approximately 4 million with Phase 3 trials exceeding 20 million dollars . Estimates From the 1980-90s suggest that clinical trial costs have increased 5 times faster than preclinical costs in the last decade . Avenues to reduce costs and improve data collection while maintaining study integrity are of high importance. Reductions in clinical trial complexity, errors and costs are critical factors that need to be addressed if valuable healthcare products are to be moved to market quickly and cost-effectively. Leveraging advances in technology and innovation can address each of these factors while improving the process and quality of clinical trials. The shift of trial activities from in-clinic to remote conduction has been escalated by the evolution of technologies and services and the demand in change due to the COVID-19 pandemic. Advancing technology allows us to shift this paradigm to better support and evaluate new investigational products in healthcare.
Decentralization of trials through the leveraging of technology and innovation advances can significantly improve the process and quality of clinical trials
Clinical site resources (e.g., staff time spent to record patient information/ perform assessments/ collect sample specimens) and data management contribute up to 40% of trial costs. Eliminating aspects of the traditional trial setup can improve on efficiency, reduce study costs and enhance patient and provider experiences. Clinical trials have largely relied on study participants to present into the clinic for predetermined assessments. Advances in technology have come to the forefront as potential tools for integration to further enable development of optimized trial strategies. For example, remote technology can assist in the following trial design components:
- Informed consent process
- Medical/Surgical and medication history intake
- Continuous patient monitoring and management
- Electronic clinical-outcome assessments
- Videoconference assessments
- Integration of specialized services (e.g., at home phlebotomy for specimen collection)
Trial Decentralization increases patient participation by providing convenience which impacts on participant compliance and retention
Trial decentralization refers to increasing components of the trial’s activities outside the clinic and back to the participants, rather than always having participants visit the clinic using the traditional paradigm. Collection of certain clinical endpoints and data remotely are straightforward (e.g., upload of biometric data, symptom tracking, medication management and adherence, patient diary, survey/questionnaire outcomes etc). The value of evolving trial operations includes hybrid study designs that can be customized based on the specific study schedule of events. In a complete transitional setting, a trial can be fully remote, with enrolment, intake and clinical evaluations all occurring from the patient’s home location. Most clinical trials are not likely to fall into this category and instead can choose to develop a hybrid protocol to decentralize components as available. For many indications, the ability of clinical endpoint evaluations that do not require patients to come into the office will have high impact. Remote advantages also include the use of remote patient monitoring and management with real-time access to data. Studies conducted in high-risk patient populations, such as those in the elderly, immunocompromised or those as risk for falls, will greatly benefit from clinical study participation shifting available assessments and data collection to remote and in-home evaluations. In addition, improving subject convenience in trial participation improves subject retention. A review of 71 randomized controlled trials revealed trial dropout rates of > 20% in 18% of the trials . Increasing patient retention can have significant impact on study costs.
Mobile Phlebotomy Services:
- Improve participant compliance with the study protocol
- Eliminate participant missed visits and loss of data
- Reduce participant or study transportation and commuter costs
- Reduce in-clinic blood draw and specimen collection staff and resource costs
One aspect of many trials that contributes to study costs are biological specimen or sample collections. Blood and urine collection are of importance in a variety of drug studies for pharmacological analysis and are typically assessed repetitively at frequent intervals. Engagement of mobile services, such as mobile phlebotomy services, to support clinical research initiatives provides a number of benefits. Mobile phlebotomy services come directly to the participant thereby improving participant compliance with the study protocol and reducing participant commuter and clinical resource costs. This is especially true for rare disease states where subject enrollment is challenging and geographical barriers exist. Participant sample collection from the convenience of their home environment also reduces potential interference or changes to samples due to stress. The stress of commuting and/or visiting a clinic for testing may impact on blood sample results. In addition, participant convenience is critical to patient enrollment and retention in clinical trials. Participant replacement or loss of data due to missed visits and/or participant withdrawal from the study can significantly increase costs or even disrupt the study integrity. Therefore, efforts to improve participant experience during the trial and convenience of trial participation are of high impact.
Overall, clinical trial operations are evolving and decentralizing as technology-driven solutions are gaining acceptance and demonstrating high impact support and benefit across many aspects of trial conduct. The integration of mobile services, such as phlebotomists for biological specimen collection, are one aspect of trial conduct that can easily be decentralized to provide improved oversight that benefits both the patient and sponsor.
Integration of mobile specimen collection services scalable and flexible for various indications and clinical trial needs prove valuable in multiple market opportunities. bring Clinical Research Home, enabling flexibility for virtual trials as well as remote monitoring, improve patient compliance and conveinance while maintaining data integrity. myOnsite has the expertise to offer their mobile phlebotomy services to aid in comprehensive trial support. myOnsite offers study specific integration of service features necessary for the study, negating the need for an in-clinic visit (e.g., remote collection of biological specimens from a certified phlebotomist).
Do you need mobile phlebotomy services for your clinical research initiatives?
myOnsite Healthcare provides a fully managed service (from Patient enrollment assistance, eConsents / eCRF setups, specimen collection, Processing to shipping/delivery) with a simplified cost model that eliminates the per-site negotiation challenges.
1. Collier, R., Rapidly rising clinical trial costs worry researchers. Cmaj, 2009. 180(3): p. 277-8.
2. Wouters, O.J., M. McKee, and J. Luyten, Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. Jama, 2020. 323(9): p. 844-853.
3. Examination of Clinical Trial Costs and Barriers for Drug Development: https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development
4. Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013;346:e8668. Published 2013 Jan 21. doi:10.1136/bmj.e8668.