Technology changes healthcare. From the earliest vaccines and antibiotics to using artificial intelligence, technology predicts the antibacterial function of a molecular structure. The development of CRISPR gene editing further showcases technological influence. There can be no doubt that technology has always, and will continue to play a pivotal role in learning and persistence in diagnostics, treatment, and many other healthcare fields.
Key Takeaways
- Despite technological advancements, clinical trial timelines and costs have remained unchanged over the past forty years.
- RxE2 identifies a key issue: the exclusion of pharmacists from clinical trial processes.
- Incorporating pharmacists improves clinical trials by simplifying processes and reducing costs through services like E2 Dispensing.
- E2 Dispensing allows pharmacists to manage the packaging, labeling, and dispensing of trial drugs, eliminating unnecessary middlemen.
- RxE2 plans to enhance recruitment in clinical trials with its upcoming E2 Recruitment service, leveraging relationships between pharmacists and patients.
Despite all of these areas in which technological advancements improve healthcare, a confounding issue arises in clinical research. In 1980, according to the Tufts Center for the Study of Drug Development, a new drug took seven to fourteen years to develop. Nine out of ten of those drugs failed to get FDA approval upon first-time submission.
Each of those drugs, successful or not, required an estimated development cost of $500 million. Forty years later, it still takes seven to fourteen years to develop a drug. Nine out of ten first-time submissions to the FDA still fail. Now, each of those drugs takes an estimated $2.6 billion to develop, whether successful or not.
Technology advancements don’t always mean improvements
Why, with the introduction of various new technologies, have clinical trial timelines and outcomes remained the same? Also, why have costs increased? One would think that, with efficient technologies and methods of communication, there would have been improvements across many, if not all, aspects of clinical trials. However, not so, as our collective clinical trial experience and the Tufts Center studies above show. Why is that?
It is that question, “Why?” that led RxE2 to uncover the root cause of unchanged trial timelines, outcomes, and costs. The answer is not figuring out what new or existing technology or platform to develop or use. Rather, it is in determining who should use that technology. Understanding this key difference has allowed RxE2 to create a new service to address these longstanding issues uniquely.
RxE2’s answer to the stagnation or worsening of the trial process is simply the pharmacist and the practice of pharmacy. RxE2 incorporates the practice of pharmacy into clinical research. They use their service to connect all pieces of the clinical trial team with pharmacies, pharmacists, and participating patients.
From modern clinical trials, pharmacists have been sidelined in clinical trials. Their roles are incidental at most. Instead, investigators, doctors, nurses, and other professionals take the lead in managing and performing trials. The existing 40-year-old clinical trial model uses manufacturers to package and label trial drugs. Then, they ship drugs to investigators, doctors, and nurses at research sites. Finally, those professionals either administer or dispense the drug product to patients.
While other healthcare professionals play important roles, the purpose is to provide investigational drugs to determine safety and efficacy. Who better to oversee these determinations than pharmacists? After all, they are the medication experts. Pharmacists already see patients regularly, answer patient questions, and provide trial information. RxE2’s services build on this natural pharmacist role in clinical trials.
Including pharmacist stakeholders
Incorporating pharmacists into trials leads to better professional training, education, and experience with trial drugs. It also simplifies the clinical trial process. RxE2’s first service, E2 Dispensing, moves packaging and labeling to local pharmacies. Here, pharmacists will package, label, and dispense clinical trial drugs according to pharmacy practices. Gone are the middlemen driving up study costs. Gone are outdated touchpoints lengthening timelines. Every piece of the trial process post-manufacture can now be done by pharmacists.
E2 Dispensing is a new platform to change the trial process. Unlike other technologies before, E2 Dispensing will deliver upon its promise. This is because E2 Dispensing answers the fundamental question: who is best suited to perform trials? The answer is the pharmacist. To accomplish that, RxE2 is building a pharmacist and pharmacy network for E2 Dispensing worldwide.
The next RxE2 service, E2 Recruitment, will address recruitment issues delaying many trials. Learning and persistence will be key. With the trusting relationship between pharmacists and patients as its backbone, RxE2 will bring trials to everyone, everywhere.
