Sponsors and CROs agree that integrating statistical modeling and knowledge of past performance into feasibility analyses improves accuracy of results
Informing the pharmaceutical drug development, manufacturing and commercialization industry.
A new report, Best Practices in Study Feasibility, from Industry Standard Research (ISR) reveals insights into how to successfully navigate many of the challenges - medical, clinical, logistical and regulatory - associated with establishing the feasibility of a clinical trial. A key area of interest for readers of the report will be the "Top Techniques and Innovations" for conducting feasibility analyses, where both sponsors and CROs report that the integration of statistical modeling and past performance into feasibility analyses is the number one technique positively affeccting the industry right now.
"ISR surveyed stakeholders from sponsors, CROs and sites to gain insight into feasibility analyses, and with the degree of differences between these groups on objectives and approaches for conducting a feasibility analysis, it is somewhat surprising to see the same concept mentioned as a top technique or innovation from both sponsors and CROs," explained Kate Hammeke, Vice President of Market Research at ISR.
In addition to findings on the top techniques and innovations used when conducting a feasibility analysis, respondents also shared their awareness of feasibility analysis service providers and frequency of use, the percentage of trials that require a feasibility analysis, whether the analysis is conducted in-house or outsourced, the data sources utilized and a ranking of which data sources contribute to the accuracy of the estimate. The report includes key statistics on the characteristics that comprise a predictive feasibility estimate, impressions on the industry's approach to feasibility analysis and the use of SOPs (standard operating procedures) and the accuracy of the estimations received from CROs, sites and specialized feasibility analysis firms as well as the potential value to be gained by engaging a specialized feasibility analysis firm under specific circumstances.
Both sponsors and CROs shared feedback on their experiences working with 23 different specialized feasibility analysis firms,
Related News
-
News Pharmaceutical Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain.
-
News Merck KGaA to buy US biotech SpringWorks for US$3.9 billion
The German multinational pharmaceutical company Merck KGaA have signed a deal to buy US biotech company SpringWorks Therapeutics at an equity value of US$3.9 billion in a move to add rare cancer therapeutics to their pipelines.
-
News Cassava Sciences halts Alzheimer's drug trial after limited progress
Cassava Sciences have drawn a close to their investigations and development of the drug simufilam, which they intended to be used for the treatment of Alzheimer’s disease.
-
News US FDA adds haemodialysis bloodlines to devices shortage list
On March 14, 2025, the US FDA published an open letter to healthcare providers citing continuing supply disruptions of haemodialysis bloodlines, an essential component of dialysis machines.
-
News Vertex Pharmaceuticals stock jumps as FDA approves non-opioid painkiller
UK-based Vertex Pharmaceuticals saw their stock shares soar as the US FDA signed off on the non-opioid painkiller Journavx, also known as suzetrigine, for patients with moderate to severe acute pain, caused by surgery, accidents, or injuries.
-
News Lessons from CPHI Milan 2024: Sunny Intervals for Pharma Manufacturing?
As the 2024 CPHI conference wrapped up in Milan, we caught up with L.E.K. Consulting – a global strategy consulting firm with deep expertise in pharma manufacturing – to discuss evolving market perspectives and business outlook. -
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement.