06Jun

The amazing speed with which the pharmaceutical industry developed, tested and won emergency approval for the COVID-19 vaccine was not just surprising, but in at least one way, misleading.

As the new report, Clinical Development Success Rates and Contributing Factors 2011 – 2020 from Bio.org makes clear, the COVID vaccines and therapeutics that became available mere months into the pandemic were a dramatic and rare exception.

On average, the report tells us it takes almost 11 years to go from a Phase I program to regulatory approval. And that’s only for those drugs and therapies that make it through. Over the 10 years from 2011, the likelihood that a drug in a Phase I trial would ultimately win approval was 7.9%.

That may be better odds than winning the Powerball lottery, however, the investment in a drug’s development can dwarf all but the largest jackpots. Making it even more of a gamble for a pharmaceutical firm is that the average success rate has declined since Bio’s 2016 report. Then the average for the previous 10 years was 9.6%.

Heavy with tables, charts and graphs, the Bio.org report (in conjunction with Informa Pharma Intelligence and QLS Advisors) reviews success rates across 21 major diseases. It reports specifics on 14 of them, combining the balance into an “Other” category. The detailed diseases are: Allergy, Autoimmune, Cardiovascular, Endocrine, Gastroenterology (non-IBD), Hematology, Infectious disease, Metabolic, Neurology, Oncology, Ophthalmology, Psychiatry, Respiratory, and Urology.

Comparing the success rates in the current report to the previous one, Bio found 12 categories had a lower likelihood of progressing from Phase 1 to approval. The largest decline was in urology. In the 2016 report, therapeutics in this category averaged 11.4% success. In the recent report, the average fell to 3.6%.

Hematology has the highest likelihood of approval at 23.9%, though it too saw a decline from 26.1%.

Drugs to treat rare diseases fared better than other therapies. The report said these drugs had a 17% likelihood of success.

The decrease, explains a Bio.org discussion of the report, “Can be attributed to two main factors: A greater participation from smaller firms participating in drug candidate development and their willingness to disclose early failures.”

Said David Thomas, BIO VP, industry research, “That all ties into what we see, which is a lower success rate overall from our last paper in 2016.”

Drug development remains difficult with far less than 1 in 10 clinical drug programs ever reaching patients,” says the Bio.org account. “It usually takes 10 to 10.5 years to develop a vaccine, which makes the existing COVID-19 vaccines on the market all the more incredible.”

Success, adds Thomas, takes “many shots on goal.”

Photo by ThisisEngineering RAEng on Unsplash

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Green Key
Jun 6, 2023

Technology Is Transforming the Clinical Research Workforce

The clinical research workforce is facing a transformation brought about by the rapid changes in how clinical trials are conducted.

New roles are already emerging, while traditional roles are evolving as decentralization and the technology to support the trend require new skills to effectively manage a trial where researchers and patient may rarely, if ever, meet in person.

new whitepaper from the Association of Clinical Research Professionals details these trends, providing a glimpse at what it means for the workforce and what the industry – researchers and the companies that support them – must do to be ready for the fast arriving future.

“Spurred in part by the ongoing COVID-19 pandemic, [decentralized clinical trials] are bringing more technology to clinical research and along with it the promise of greater efficiency, productivity, and effectiveness,” says Jim Kremidas, ACRP’s executive director. “But to fully realize that potential, roles will need to evolve and operate differently to accommodate this new environment.”

Produced by a group that included representation from technology suppliers, contract research organizations, sites, and more, the whitepaper reached four major conclusions:

  • The majority of clinical trials that implement decentralization, at least in the short term, will be hybrid trials, and aspects of decentralization (e.g. virtual visits) will be leveraged more often and receive more overall acceptance by industry due to COVID-19.
  • Increased use of technology will impact nearly every role. But rather than being a threat to job roles, it will generate the need for the evolution of existing roles and bring unprecedented flexibility and efficiency.
  • New roles likely to emerge include Tech Trainer for CROs, Site Tech Support, Remote Trial Coordinator, Decentralized Investigator, Virtual Patient Guide, and more.
  • Technology training must be standard practice and written into each site manual and delegation log.

In addition to highlighting the growing use of technology – including remote monitoring devices — The Impact of Increased Technology Use on the Clinical Research Workforce defines fully decentralized and “hybrid” trials, discusses the impact of technology workforce roles and details the emerging new jobs.

Photo by Lucas Vasques on Unsplash

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Green Key

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