info@ngageittec.com

nGageIT’s Digital Medicine Solution reduces Clinical Trial costs

We detect the medicine you take from your breath.

nGageIT’s Digital Medicine Solution reduces Clinical Trial costs

Revolutionizing the Clinical Trial Industry is a $65 Billion opportunity for nGageIT

nGageIt Digital Medicine detects the medications taken from the “breath” of patients using their revolutionary NanoSmart breaths sensor technology. nGageIT’s solution allows patients in clinical trials to be monitored “truly” digitally in a verifiable manner. nGageIT facilitates “site-less” clinical trials by detecting the point of ingestion of the patient with their oral medication and autonomously transmitting this data to the cloud for every dose which allows investigators to verify adherence remotelyin real-time. In this manner, patients in the trail are automatically flagged in real-time and can be eliminated from the trial so that patients who finish the trial are verified to be 100% adherent. This reduces the costs of oversampling and recruitment. Additionally, medication gets through the regulatory process faster and safer which reduces “slippage” and increases revenue to pharmaceutical manufacturers by $3 million to $8 million per day for strategic molecules.

nGageIT NanoSmart BioSensor

nGageIT can reduce non-adherence by more than 20% in clinical trials which reduces costs by $ 7 million per average phase 3 clinical trial. This improves time to market and reduces slippage. Remote Mobile Breath testing by nGageIT sensors attached to smart phones is cost efficient and eliminates the need for most costly or invasive monitoring such as blood tests. Additionally, patients who are non-compliant are identified early and eliminated.

Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost

Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.

The long duration and subsequent costs of conducting clinical trials has always been at the forefront of development organizations within biopharmaceutical enterprises, as clinical trials remain costly and continue to increase in duration. Although novel initiatives aimed at improving study efficiency and data quality (i.e., RBM, adaptive trial design, and novel pilots) offer promise to reduce trial duration and cost impact, the biopharmaceutical industry is overlooking one critical element that affects study timelines: patient non-adherence. In this article, we will touch on clinical trial costs, understand the impact of non-adherence on study duration, and model the cost of non-adherence.

Clinical Trial Costs

Table 1 demonstrates the average estimated cost of enrolling patients for all therapeutic indications in a variety of study phases.

Table 1 demonstrates the average estimated cost of enrolling patients for all therapeutic indications in a variety of study phases.

 

There are several activities that contribute towards clinical trial budgets; from a general standpoint, these costs include per-patient costs (such as patient recruitment and retention), study site costs (such as investigator fees, site staff / administrative fees, IRB fees, procedure fees), and per-study fees (such as data collection fees, monitoring, sponsor / CRO personnel salaries, protocol amendment fees, and vendor costs). However, asides from the fact that study timeline slippage unexpectedly expands study budgetary forecasts, timeline slippage also results in a $600K per day in lost revenue opportunity for niche products, and up to $8 Million per day for blockbuster medical products.

Prevalence of Study Non-Adherence

Figure 1 illustrates that approximately 40% of patients become nonadherent to IMP after 150 days in a clinical trial

It would be ideal if all patients adhered to investigational medical product (IMP) and the study protocol, nonetheless, many patients do not. Figure 1 illustrates that approximately 40% of patients become nonadherent to IMP after 150 days in a clinical trial, and Figure 2 demonstrates that IMP nonadherence not only causes temporary bouts of toxicity (double dosing) and lack of efficacy (skipping doses), but also introduces data variability into the equation.

Figure 2 demonstrates that IMP nonadherence not only causes temporary bouts of toxicity (double dosing) and lack of efficacy (skipping doses), but also introduces data variability into the equation.

Increases in data variability means that study teams need to enroll more patients in order to achieve the study’s statistical outcomes. It is important to emphasize that linear increases in non-adherence has an exponential impact on the number of patients needed to yield the same statistical outcome. To demonstrate, a 20%-30% IMP non-adherence rate requires a 50% increase in the study’s sample size in order to maintain equivalent statistical power; once non-adherence increases to 50%, the trial sample size needs to increase by 200% in order to maintain equivalent statistical power.6 Yet, discussion amongst industry professionals on the topic suggests that study scientists do not factor patient non-adherence in trial design.

Cost Impact of Clinical Trial Non-Adherence

We have demonstrated previously that patient nonadherence in clinical trials leads to enrolling more patients to achieve the same statistical outcomes, increases study timeline slippage, and subsequently, elevates operational costs. In this section, we will estimate the cost of non-adherence, and the opportunity cost of reducing non-adherence.

Table 2 models the operational costs associated with clinical trial IMP non-adherence.

Table 2 models the operational costs associated with clinical trial IMP non-adherence.

Source of information used in this analysis for aggregated clinical trials and patient average data: www.clinicaltrials.gov via www.karmadata.com

1,273 trials and corresponding patients that were categorized as N/A by phase were re-allocated based on existing trial allocation patterns
Medication nonadherence impact based on 30% and 50% non-adherence rates requiring 50% and 200% increases in sample size respectively
Does not include costs of investigational product; only project management and enrollment costs are included
Per patient costs: http://www.prnewswire.com/news-releases/phase-3-clinical-trial-costs-exceed-26000-per-patient-56447427.html
Patient Non-adherence in Clinical Trials: Could There Be a Link to Post Marketing Patient Safety? Dorothy L. Smith, PharmD, Drug Information Journal, 46 (I) 27-34, 2012
Table 2 delineates that, on average in all therapeutic indications, a Phase III trial needs to enroll an additional 460 patients (totaling 828 patients (Table 1) in order to maintain equivalent statistical power, assuming a constant 40% IMP non-adherence rate. The operational cost to enroll 460 patients is estimated at $12 Million. By reducing IMP non-adherence by 1% (to 39%), sponsors need to enroll 13 less patients in order to maintain equivalent statistical power, resulting in approximately $336K in cost savings, and naturally, minimizing timeline slippage.

Addressing Non-Adherence

The analysis above shows only one case of study non-adherence (IMP non-adherence), which has a direct impact on data variability and statistical outcomes. When combined with other forms of clinical trial non-adherence (i.e., subject dropout, not completing ePRO questionnaires, missing study visits, and not adhering to study procedures, etc.), further study prolongation is imminent.

The issue of nonadherence can easily be addressed with novel technologies. For example, Artificial Intelligence (AI) has advanced to the point where it is capable of acting as a digital companion with patients to guide them through a clinical trial. IMP reminders, answering questions, and study procedure guidance can all be automated through AI, and preliminary data is showing promise.8 Additionally, novel patient centric study design models are now introducing innovative ways of collecting clinical data via Electronic Device Reported Outcomes (eDROs), or data collected directly from patients through wearables and mHealth.

In the future, it is likely that advanced technologies and patient centric study design will not only make studies more convenient and accessible for patients, but also improve patient compliance with study procedures and IMP, generate higher data quality and ultimately shorten study duration and minimize cost impact.

References

http://www.appliedclinicaltrialsonline.com/why-are-cancer-clinical-trials-increasing-duration
Key cost drivers of pharmaceutical clinical trials in the United States, Aylin Sertkaya, Hui-Hsing Wong, Amber Jessup, Trinidad Beleche, Vol 13, Clinical Trials, Issue 2, pp. 117 – 126, First published date: February-08-2016
http://www.prnewswire.com/news-releases/clinical-trial-delays-cost-pharmaceutical-companies-55044607.html
Source of information used in this analysis for aggregated clinical trials and patient average data: www.clinicaltrials.gov via www.karmadata.com
Per patient costs, www.clinicaltrialbenchmarking.com: http://www.prnewswire.com/news-releases/phase-3-clinical-trial-costs-exceed-26000-per-patient-56447427.html
Smith, Dorothy PharmD, Patient Nonadherence in Clinical Trials: Could There Be a Link to Post Marketing Patient Safety?, Consumer Health Information Corporation, October 2011
Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Blaschke TF1, Osterberg L, Vrijens B, Urquhart J., Annu Rev Pharmacol Toxicol. 2012
http://medcitynews.com/2017/04/study-medication-adherence-ai-supported-selfies-highlights-potential-clinical-trials/

 

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

%d bloggers like this: