New Study Addresses ‘$28 Billion Problem’ of Research Fidelity
In the U.S. alone, around $28 billion a year is spent on preclinical research that is not reproducible, and low reproducibility rates contribute to both delays and costs of therapeutic drug development.
In the U.S. alone, around $28 billion a year is spent on preclinical research that is not reproducible, and low reproducibility rates contribute to both delays and costs of therapeutic drug development, according to a study published on June 9th, 2015 in the PLOS Biology journal by the Global Biological Standards Institute (GBSI) and two economists.
Analysis of past life science research studies indicates that the cumulative prevalence of irreproducible preclinical research exceeds 50%, and action is now required, noted the three authors, Drs. Leonard P. Freedman, Iain M. Cockburn and Timothy S. Simcoe.
"To achieve greatest levels of reproducibility, The Economics of Reproducibility in Preclinical Research offers tangible solutions - providing guidelines for advancing education and training and applying best practices in life science research. The valuable time, money and resources saved will mean finding faster treatments and cures," stated Freedman, who is president of GBSI.
Reviewing publicly available data from government sources, industry and analyst reports and scientific articles, the authors conducted an in-depth analysis of the key components of irreproducibility and used secondary research to benchmark the potential impact of improved standards. They think the causes of irreproducible research can be grouped into four categories: biological reagents and reference materials, study design, data analysis and reporting, and laboratory protocols. Of these, errors in biological reagents and materials (36% of total) and study design (28% of total) are the two largest factors.
By categorizing the root causes of irreproducibility and estimating their relative importance, it is possible to prioritize potential solutions, and ultimately, increase the overall return on public and private investments in research and development, they explained.
"Improving reproducibility levels will require a measured investment in time and resources," noted Cockburn. "We recommend investing in practical solutions and taking immediate steps in the areas where there will be the greatest return on investment."
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
