As the year comes to a close, we are reminded how deeply important great clinical trial oversight is to both the clinical trial ecosystem and to the world. COVID has pushed us all to be more thoughtful, resilient and efficient in the work we do, and what we are all living through is truly a turning point for how clinical trials happen.
Improving clinical trials and clinical trial oversight for the benefit of every stakeholder -- from sponsors all the way through to patients -- is one of the most compelling opportunities of our time. Nothing less than the future of healthcare is on the line, and every step in the process counts. As creators of breakthrough trial oversight software, we are committed to making clinical trial oversight more efficient and effective, and we see ways to support stakeholders at every level of the process.
Today we zoom out and take a look at some of the statistics behind clinical trials and oversight work to see how devastating delays and disruptions can be, opportunities to address those problems, and explore what all of this may reveal about the future of clinical trial oversight.
CLINICAL TRIAL OVERSIGHT STATISTICS -- THE BIG PICTURE
Providing safe and effective treatments has never been more important, and that demands focus on improving the effectiveness of oversight. In the short term, we continue to see the critical importance for addressing COVID-19, but in the longer term it’s clear that we must address the growing healthcare needs of an aging global population.
1967: The year that an NIH external advisory group “first introduced the concept of a formal committee charged with reviewing the accumulating data as the trial progressed to monitor safety, effectiveness, and trial conduct issues in a set of recommendations to the then-National Heart Institute.” While DMC’s had been a part of some clinical trials since the 1960’s or earlier, it has been about 55 years since they were formally recommended by the NIH. (source: https://www.fda.gov/)
$198 billion: Estimated global spending on Pharma R&D in 2020. (source: statista)
18,582: The number of drugs currently in the R&D pipeline as of October 2021. (source: statista)
Oversight innovation through smart software means that the hundreds of billions spent in drug development will be used as efficiently and effectively as possible. The post-COVID oversight world will live online, and we are already shaping how it can build the future on top of the first 50 years.
CLINICAL TRIAL OVERSIGHT STATISTICS -- COST OF DRUG DEVELOPMENT
It is shocking just how costly study delays and disruptions are, and a major challenge is how normalized study disruptions are. Smart software in clinical trial oversight will continue to grow and expand as an effective tool for mitigating those risks and costly delays and disruptions.
$2.6 billion: The average cost of developing a drug in the United States, as of October 2021. (source: statista)
$600,000 and $8 million: What each day of trial delay during a product’s development and launch can cost sponsors. (sources: pharmafile and antidote)
9 out of 10: Number of trials that require the original timeline to be doubled in order to meet enrollment goals. (source: antidote.com)
Smart software is an easy-to-implement, powerful tool for efficient oversight that has immediate impact on data security and oversight committee communication. There is no going back to how things were before COVID, and we are thrilled to be driving innovation across the clinical trial oversight ecosystem that will impact stakeholders and processes across the board.
CLINICAL TRIAL OVERSIGHT STATISTICS -- THE IMPACT OF COVID
New study launches took a massive hit in 2020 when the initial COVID outbreak happened, and the ripple effect is still making an impact across the clinical trial oversight ecosystem right up through the end of 2021. What we see is that COVID-19 slashed the number of active studies, pushing everything back, and making the queue for new studies even longer.
57%: The percentage of studies initiated in the U.S. from February to May in 2020 vs. what would have been expected had the pandemic not occurred. (sources: pubmed.ncbi.nlm.nih.gov and nature.com)
77%: The percentage of studies initiated outside of the U.S. from February to May in 2020 vs. what would have been expected had the pandemic not occurred. (sources: pubmed.ncbi.nlm.nih.gov and nature.com)
40,000: Number of already-enrolled patients impacted by the disruption of trials by COVID-19 (source: centerwatch.com)
44%: Percentage of the more than 2,600 clinical trials stopped in the first five months of the 2020 that cited the COVID-19 outbreak as the cause. (source: centerwatch.com)
Moving forward, the clinical trial ecosystem will need newer, better and ever more efficient ways to oversee studies, both to make up for lost time and to manage the ever-growing number of new studies. Smart software is the answer, and the way forward.
With all of this in mind, shouldn’t your clinical trial oversight team use the best possible oversight software?
Learn more about how Cloud Concinnity can support your clinical trial oversight