Clinical Trials And Drug Development Process

By Author: Kimberly Brue
Total Articles: 23
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Clinical Trials and Drug Development Process
We asked an experienced physician for a solid opinion on needed improvements in the clinical space and pharma’s pursuit of licensed drugs. Dr Kenyatta Cosby, MD, provided us with this perspective. He is a seasoned and published practitioner with many successful and highly-regarded trials under his belt – and someone who definitely understands the strategic and operational pursuits of the drug development process. We are proud to have Dr Cosby provide his expert opinion on today’s clinical climate and opportunities to streamline the drug development pipeline

Dear Colleagues,

If you are a pharmaceutical executive, senior health administrator, or public policy-maker, please indulge me for a moment to be reminded that continued investments into innovative ideas are what’s needed in order to transform current challenges within the drug-development and randomized clinical trial (RCT) process. For decades, scientific and business-centric stakeholders have struggled to produce a pathway that enables the transformation of intuitive workflows, advanced analytics, ...
... and smart devices (i.e., cloud-based connectivity) into a robust pipeline for discovering blockbuster medications like Keytruda1, Humira2, Eliquis3, Opdivo4, and Imbruvica5.

New vaccine operations being implemented by leading drug-makers and the federal government in response to the global COVID-196 pandemic have offered renewed hope about a new logistical framework to help accelerate RCT. Surprisingly, it was only in 2014, when a widely-held therapeutic reality was published in _the New York Times_7 which suggested that fewer blockbuster drugs were being produced and the financial requirements for a novel drug to enter the therapeutic marketplace in the United States was becoming too costly.

Today, however, the good news is that the former is no longer true; drug makers are now seeking more novel drug approvals8 from the Food and Drug Administration (FDA)9. The automation of many operations and the creation of specialized workflows via biometric and RFID enabled smart devices had a lot to do with integrating biotech labs with commercial organizations. Unfortunately, the part about high costs still holds, and in some regards is getting worse. A new study published by a team at MIT Sloan School of Management and the Laboratory for Financial Engineering10, suggests that the current cost to bring a new drug to the market is estimated to be as high as $2.8 billion11, with two-thirds of this cost going to the clinical trial process, and 90%12 of these trials failing.

Notwithstanding these hard facts and other frustrations throughout the drug commercialization process, there is an emerging consensus by key stakeholders to bet on leveraging artificial intelligence (AI)13 and machine learning capabilities to ensure scientific integrity and contain cost over time. Some of the newest platforms utilizing this technology are geared towards “site-less” clinical trials14 and the acceleration of time needed to receive FDA-approval. A leader in this space is Janssen Clinical Innovation (JCI)15, part of Janssen Research & Development, LLC.

JCI has demonstrated notable successes with clinical initiatives such as their utilization of direct-to-patient and real-world data platforms. Key examples of their business platforms are a large-scale observation and treatment program, mSToPS16 (short for mHealth Screening To Prevent Strokes), the use of digital technology to decrease paperwork and logistical challenges (i.e., eConsent17, registrational clinical trial18) and iSTEP19 (short for Integrated Smart Trial & Engagement Platform).

However, when it comes to making a significant change at the individual level and maximizing the workflow within a 24-hour work cycle, P360 is a clear leader in this space. They specialize in robust clinical trial management systems, which are easy to integrate and produce a seamless flow of functionality across operations (i.e., start-up, enrollment, execution, and tracking). P360’s most revolutionary tool is Curotrak, which is a cloud-based trial management software suite that allows the clinician centralized safeguards over multiple programs in terms of processes and data safety involved with planning, implementation and closeout activities. These innovative tools provide a broad change in the traditional clinical trial approach that gives corporations a customer-focus within regulatory guidelines.

To my knowledge, the current COVID-19 RCTs are focus on five clinical stages of the disease process: Pre-exposure prophylaxis, Post-exposure prophylaxis, Hospital admission, Late-stage critical care and Outpatient treatment. The outcome data for each area has been promising, but there is still a need for caution given that various studies have only demonstrated incremental reductions in patient mortality. This is where innovative solutions like Swittons, an loT powered smart device by P360, can use advanced analytics and AI deployment via automated messaging and push/pull data streaming to accelerate sales operations for pharmaceutical organizations. It is these types of solutions that will ultimately enhance commercial value to the “customer experience”.

Forward-thinking companies like Merck48, AbbVie49, Bristol-Myers Squibb50, Pfizer51, and Johnson & Johnson52 have always known the power of innovative-thinking, and such understanding will allow them to remain dominant global drug-makers with incredible therapeutic momentum. The odds are that their sales forecasts based upon investments in innovative ideas will eventually manifest as a great stock performance over the next several years.

The ultimate news for drug-development stakeholders is that the work to develop time-sensitive pathway for streamlining operations with intuitive workflows, advanced analytics, and smart devices has already begun. Bloomberg Press53 reports promising revenues for the RCT service markets, which are slated to grow 10% annually for the next 5 years and will be worth $150 billion by 2030. And this is why smart investments in solutions from companies like P360 is so important.

To learn more about all of P360’s innovative products, visit P360.com.