How Learning and Persistence is Changing Clinical Trials for Better

Smiling woman scientist in lab with arms crossed looking at camera

Technology changes healthcare. From the earliest vaccines and antibiotics to using artificial intelligence to predict the antibacterial function of a molecular structure and the development of CRISPR gene editing, there can be no doubt that technology has always, and will continue to always play a pivotal role in the healthcare fields of diagnostics, treatment, and many others.

Despite all of these areas in which technological advancements and breakthroughs have improved healthcare, however, a confounding issue arises in the field of 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, and 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, and nine out of ten first-time submissions to the FDA still fail. Now, however, 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 all of the various new technologies throughout those forty years, have clinical trial timelines and outcomes remained the same? Why have costs increased? One would think that, with so many more efficient technologies and methods of communication, from computers and the internet to cellphones and apps, there would have been dramatic improvements across many, if not all, aspects of the clinical trial process. 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 why clinical trial timelines, outcomes, and costs have not improved. The answer is not found in trying to figure out what new or existing technology or platform to develop or to use, but rather it is found in determining who should use that new or existing technology or platform. Understanding this key difference has allowed RxE2 to create a new service that can actually address these longstanding issues in a way that no other technology or platform has been able to.

RxE2’s answer to the question of the stagnation or worsening of the clinical trial process is, simply, the pharmacist and the practice of pharmacy. RxE2 incorporates the practice of pharmacy into clinical research, using its service to connect all pieces of the clinical trial team with pharmacies, pharmacists, and participating patients.

From the inception of modern clinical trials, the practice of pharmacy and their pharmacist have been sidelined in clinical trials, their roles relegated to incidental use, at most. Instead, investigators, doctors, nurses, and other healthcare professionals have taken the lead in managing and performing clinical trials. The existing 40-year-old clinical trial model uses large scale manufactures to package and label clinical trial drug. Then, those manufactures ship that drug to the investigators, doctors, and nurses who are performing the clinical study at research sites. Finally, those healthcare professionals either administer or dispense the drug product to patients at the research sites.

While these other healthcare professionals can have important roles to play in clinical trials, the purpose of pharmaceutical clinical drug research is to provide investigational new drugs to patients to determine if they are safe and if they work. Who better to oversee these determinations than pharmacists? After all, they are the medication experts. Pharmacists already see patients regularly for drug fills, they already answer patient questions, and they are already the perfect healthcare professional to provide patients with information on the latest drug trials and how those patients can enroll. RxE2’s services build on this natural fit for pharmacists in clinical trials.

Including pharmacist stakeholders

Incorporating pharmacists into the clinical trials, as RxE2 has done, not only leads to a better alignment of professional training, education, and experience with clinical trial drugs, but also dramatically simplifies the entire clinical trial process. RxE2’s first service offering, E2 Dispensing, moves the packaging and labeling of clinical trial drug from existing packaging and labeling companies to local pharmacies, where pharmacists will package, label, and dispense clinical trial drugs supplies according to the practice of pharmacy. Gone are the middlemen that drive up study costs. Gone are the multitude of outdated trial touchpoints that only lengthen timelines and introduce more potential for poor data or errors. With E2 Dispensing, every single piece of the clinical trial process post-manufacture can be performed by a single actor: the pharmacist.

E2 Dispensing is a new platform that promises to change the clinical trial process. Unlike other technologies and platforms that have come before, however, E2 Dispensing will deliver upon that promise, because, unlike the others, E2 Dispensing answers the most fundamental question: who is best suited to perform clinical trials? The answer is clear, the pharmacist. To accomplish that goal, RxE2 is building a network of pharmacists and pharmacies to provide E2 Dispensing worldwide.

The next RxE2 service, E2 Recruitment, will address the long-standing recruitment issues that have delayed and even cancelled many clinical trials in the past.  Once again, with the trusting, personal relationship that exists between pharmacists and their patients as its backbone, RxE2 will bring clinical trials to everyone, everywhere.


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