Never in our lifetimes have we experienced such rapid, monumental change—everywhere, globally. From the COVID-19 pandemic to social unrest, the world is reverberating with revolutionary shock waves demanding every industry and sector of society to do one thing: Reimagine. This includes life sciences, clinical trials and how we deliver new medicines—particularly a treatment for the coronavirus gridlock—to the world. We must reimagine new pathways.
Pandemic Puts Studies on Pause
A GlobalData study reports that 70% of clinical trials around the world have been disrupted since April 2020 due to COVID-19. Think about it. Clinical trials disruptions are not only bottom-line losses for the life sciences companies that sponsor these trials, but they also inflict incalculable losses for patients awaiting cures. What’s worse is in the case of cancer clinical trials, volunteer patients often depend on the investigational product for survival—which may be their last hope. For these and many other scenarios, continuing clinical trials and reducing time-to-market bottlenecks and inefficiencies are imperative. We must reimagine new pathways.
The probability of a drug making it to market after three complex phases of clinical research is less than 10%. In fact, the success rate is closer to a mere 3-7%.
Whether we’re talking COVID-19, a new beta blocker for heart conditions, or a cutting-edge immunotherapy for cancer, there’s a striking reality for all clinical trials: The probability of a drug making it to market after three complex phases of clinical research is less than 10%. In fact, the success rate is closer to a mere 3-7%. We must reimagine new pathways.
What are the key root causes for decade after decade of such high drug development failure rates continuing to hover at a dismal 93–97%? There are multiple contributing culprits, but the primary impediments include:
- Patient recruitment and retention: 85% of clinical trials fail to retain enough patients through to completion.
Scientific and operating efficiency: Over 50% of clinical trials miss regulatory filing deadlines for completion and market approval.
- Escalating cost: The average cost to bring a single drug to market has escalated to nearly $2 billion, with clinical trials incurring an average burn rate of $1 million per day, per study. Any delay in trials can increase the chances of a study being discontinued—not necessarily for scientific or medical reasons—but for operational, cost-related reasons and how trials are managed.
These root causes then bring the spotlight back to COVID-19. While this pandemic has hurled devastating blows in disrupting clinical trials, it’s simultaneously swung open the door to innovation through virtual integration and optimization. Let’s consider how through the lens of three key levers:
Patient Access and Experience—Making Trial Participation Easier
All too often, the key to a successful clinical trial is engaging participants through completion of the study. In too many cases, onsite participation involves multiple logistical hurdles—juggling schedules, transportation, etc.—which eventually contribute to that 85% retention failure statistic. Add an infectious pandemic to the mix, and things get even worse.
Now, imagine telemedicine where patients use cyber-secure, HIPAA-compliant video platforms for virtual clinical office visits. Via telemedicine, clinical patients can interact in real-time with their clinical physicians and inform of updates—improvements, side effects, adverse reactions, etc. Imagine mobile labs going to the patient’s home to conduct blood draws and third-party imaging vendors doing the same to perform an MRI or CT scan for the patient’s convenience.
Lastly, imagine a drug supply chain logistics system where the trial medicine or medical device is delivered directly to the patient’s home through trackable Interactive Response Technology (IRT). At the same time, imagine wearable technology collecting vital signs including blood pressure, heart rate, temperature and oxygen levels and transmitting that data securely to clinical physicians.
When more can be done virtually from home, fewer onsite visits are required. This results in higher patient retention, increased trial continuity and enhanced patient access and experience. We must reimagine new pathways many of which today aren’t just wishful thinking—they’re real-world possibilities.
Cross-Functional Optimization—Reducing Inefficiencies
Redesigning clinical trials processes (e.g. trial design, investigator site selection and clinical data analysis and reporting, etc.) can result in significant cycle time and cost reductions and eliminate bottlenecks. Modeling and simulation of these and other clinical research workflows can render nearly unimaginable advances through predictive and clinical data modeling.
“Optimization through modeling and simulation resulted in $125 million in avoided R&D costs for a leading, global pharmaceutical company’s clinical program.”
Imagine taking years of research effort out of clinical processes by predicting the outcome in advance through next-level analytics and technology integration. Now, imagine designing clinical trials protocols that eliminate delay-inducing errors and rework. What about devising the most optimal regulatory strategy that increases probability of approvals to market your drug—all through process redesign and optimization and with improved GCP and GDP?
Amazingly, these are all possible. In fact, optimization through modeling and simulation resulted in $125 million in avoided R&D costs for a leading, global pharmaceutical company’s clinical program. We must reimagine new pathways.
Data Management and Compliance—Better Filings Mean Greater Success
There are many good reasons why it’s hard to bring a drug to market—safety, efficacy, adverse reactions, etc. No one argues with that. But from a business standpoint, there are no good reasons to operate inefficiently and fail to meet FDA and other regulatory requirements.
There are ways to bridge the gap, however. For example, virtual regulatory audits and inspections can reduce travel and physical footprint through video walkthroughs. They can also enable quicker audit and inspection documentation. Imagine remote data and document management systems that centrally house electronic records, ensure virtual access and reduce paper-based forms. Ultimately, these all lead to higher quality inputs and compliance for greater filing success.
More Efficient Clinical Trials Benefit Everyone
Finally, the next time you take a pill from your medicine cabinet, think about what went into making that therapy possible: clinical trials, doctor’s visits, regulatory filings, data accuracy, good documentation, and more. Now imagine the diseases and conditions still out there with no cure. If they face the same obstacles the pill in your hand faced, inefficiencies may mean they never make it to market.
“The doorway to disruptive innovation is open to us along with needed tools to revolutionize clinical trials.”
But now, reimagine a more sophisticated use of tools, technologies and processes that can make clinical trials more efficient so that ideas born in the lab can more seamlessly and cost-effectively be realized in the world.
The doorway to disruptive innovation is open to us along with needed tools to revolutionize clinical trials. For so many patients looking for hope, however, their priority is much simpler. All they want is a cure, whether a pandemic persists or not. Reimagining and creating sustainable clinical research solutions can help make this a reality. We should all commit to do so through new, available and very possible pathways available to us today. Contact us to learn how RGP can be your partner in reimagining clinical trials.