Next Stop on the Forgotten Mile: Clinical Trials

Clinical trials are the lifeblood of the pharmaceutical industry. Without successful new drug development, brands would become commoditized as patents expire and low-cost generics enter the market.

To understand where new drug development is concentrated, we must look at the leading causes of death. The 2016 CDC National Vital Statistics Report, Deaths: Final Data for 2013, calculates the 15 leading causes of death in the U.S. in 2013:

1. Diseases of heart (heart disease)
2. Cerebrovascular diseases (stroke)
3. Alzheimer’s disease
4. Diabetes mellitus (diabetes)
5. Influenza and pneumonia
6. Nephritis, nephrotic syndrome and nephrosis (kidney disease)
7. Intentional self-harm (suicide)
8. Septicemia
9. Chronic liver disease and cirrhosis
10. Essential hypertension and hypertensive renal disease (hypertension)
11. Parkinson’s disease
12. Pneumonitis due to solids and liquids.
13. Malignant neoplasms (cancer)
14. Chronic lower respiratory diseases
15. Accidents (unintentional injuries)

Graph from CDC National Vital Statistics Reports titled Deaths: Final Data for 2013

While deaths from some diseases have been trending slightly downward, ailments such as Parkinson’s, Alzheimer’s and kidney disease have risen. Add to that the need for new vaccines for age-old diseases like malaria and Ebola, and headlining epidemics like Lyme Disease and Zika, the need for new drugs has never been greater.

Development of new pharmaceuticals to treat these diseases is the focus of drug companies worldwide. This is evident when you look at the massive increase in the number of clinical trials in the past decade. A well-designed clinical trial is essential to assess the efficacy and safety of new drug candidates.

NIH data shows increase in the number of clinical trials in the U.S. from 2001 to 2009.

The more advanced medications become, the more likely they are to be temperature sensitive and to require proper cold chain storage. And because clinical trial drugs are often stored outside of normal hospital conditions, standard practices related to refrigerated medications may be overlooked. This is part of what we call The Forgotten Mile, the often missed portion of the cold chain where pharmaceuticals are stored for clinical trials, sales rep distribution, and pharmacy dispensing.

Typically for clinical trials, Investigational Medicinal Products (IMPs) are transported in totes from the manufacturer’s warehouse to the trial site or hospital. Continuous temperature monitoring presents an opportunity to help ensure trial success by providing visibility into storage conditions at remote sites. SmartSense’s unique Bluetooth sensors work in combination with any smartphone or tablet to log data in real-time. Every sensor reading is stored and accessible in Insights, our cloud-based remote monitoring platform. On our platform, you can see the current condition of your totes and receive actionable alerts and information that will help you improve operational efficiency and responsiveness.

Also included in the Forgotten Mile is the clinic or hospital refrigerator or freezer used to store the IMPs. Replacing paper logs with automated monitoring immediately improves your insight into the storage of your pharmaceuticals. Continuous monitoring ensures medications quality and trial success.