PAASP US receives SBIR award

PAASP US receives a $1.47M Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to develop tools to evaluate nonclinical biomedical research quality

The PAASP Network, a global group of independent organizations with a common goal of promoting research quality standards, is thrilled to announce that Network member PAASP US, LLC has been granted a Phase II award through the Small Business Innovation Research (SBIR) program supported by the United States National Institute on Drug Abuse (NIDA) at the NIH.  This grant follows a successful Phase I SBIR award and will lead to the development of a robust web application with proprietary analytics supporting project-specific and research unit-specific certification of nonclinical research data quality.

“Robust nonclinical data is an absolute requirement for building an effective translational strategy and developing clinically safe and effective medications,” said Daniel Deaver, Ph.D., CSO of PAASP US and one of the Principal Investigators of the grant. “Most current efforts to facilitate generation of robust nonclinical research data focus on producing guidelines and checklists pertaining to study design and data analysis, but do so mainly from a reporting perspective, rarely consider processes other than study design and data analysis (such as compliance of data records with FAIR principles), and are at risk of triggering normative responses, whereby research teams simply satisfy the guidelines at a time when it is too late to take corrective actions.”

The PAASP US team will work on a novel research evaluation tool – PAASPort® – for early identification of potential risks of bias related to nonclinical research practice. “PAASPort® was created by industry and academic scientists working with business professionals,” said Andre Der-Avakian, Ph.D., COO of PAASP US and the other Principal Investigator of the SBIR award. “It will allow funding organizations such as private investors, non-profit foundations, and corporate and non-corporate VCs to inform both financial (investment) and portfolio (science) decisions by supporting research with low risks of bias, thereby improving the probability that basic nonclinical discoveries will translate into safe and effective clinical treatments.”

During Phase I of the project, the PAASP US team converted an existing paper-and-pencil PAASPort® prototype into a web-based, interactive digital tool.  During Phase II, the team will focus on developing and implementing analytical mechanisms to support semi-automated processing of data quality information collected from the online assessment and demonstrating economic benefits of improved nonclinical research practice quality assessments for research investors.

The project will draw on the expertise of a highly motivated and collaborative team of PAASP US employees, advisors and consultants across multiple locations in the US and Europe.

About the PAASP Network

The PAASP Network (Partnership for Assessment and Accreditation of Scientific Practice; www.paasp.net) is an unincorporated association of legally and operationally independent entities (one of which is PAASP US, LLC) acting in different countries, but united in the global goal to promote research quality standards. The Network’s membership includes in vivo and in vitro scientists across several biomedical disciplines, business professionals, and entrepreneurs. As of July 2020, the Network includes members and member organizations in the US, Germany, Benelux, Italy, Russia, Baltic States, and France.

About SBIR

The Small Business Innovation Research (SBIR; www.sbir.gov) program is a highly competitive program that encourages US domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential. By including qualified small businesses in the nation’s R&D arena, high-tech innovation is stimulated and the US gains entrepreneurial spirit as it meets its specific research and development needs.

Media Contacts

PAASP US, LLC:

Patricia Kabitzke, Ph.D., CEO

patricia.kabitzke@paasp.net

The PAASP Network:

Anton Bespalov, M.D., Ph.D.

anton.bespalov@paasp.net

Data analysis – Issues, challenges and solutions

The first official meeting of the Preclinical Data Forum took place in Berlin in 2014 and one of the central seminars was given by Viswanath Devanarayan, head of Discovery Biostatistics at AbbVie at that time. And the first thing Devan did was to tell us the following story:
A biologist and a statistician are in the death row, and are to be executed around the same time. They are each granted one last request. The statistician: “I want to give one last seminar”. The biologist: “I want to be executed first”.
We invited Devan to explain the famous Ioannidis 2005 paper “Why Most Published Research Findings Are False”. Devan did a great job. Explanations were at our, non-statistician, level, simple and yet professional, convincing and leaving no doubt about the importance of the claims made in that paper.

In the ideal world, biomedical researchers would always go to professional statisticians for help. But we know that this is usually not possible for most preclinical scientists, who nevertheless need help and cannot get such simple answers from attending yet another statistics course or reading yet another book or other resource that is actually not meant for non-statisticians.
We would like to collect typical data analysis problems that scientists often face and for which solutions are not readily available. We will approach professional statisticians and, with their help, try to develop answers and examples that could help our peer scientists.

The first such piece is in the following section.

https://test2.paasp.net/wp-content/plugins/biological-vs-technical-replicates-now-from-a-data-analysis-perspective/

New Author Guidelines for Displaying Data and Reporting Data Analysis and Statistical Methods in Experimental Biology

To improve the robustness and transparency of scientific reporting, the American Society for Pharmacology and Experimental Therapeutics (ASPET), with input from PAASP’s Martin Michel, T.J. Murphy and Harvey Motulsky, has updated the Instructions to Authors (ItA) for ASPET’s primary research journals: Drug Metabolism and DispositionJournal of Pharmacology and Experimental Therapeutics, and Molecular Pharmacology. The revised ItA went into effect on January 1st 2020. Details and the underlying rationale are described in an editorial/tutorialthat appeared in all three journals.
Key recommendations include the need to differentiate between pre-planned, hypothesis-testing on the one, and exploratory experiments on the other side; explanations of whether key elements of study design, such as sample size and choice of specific statistical tests, had been specified before any data were obtained or adapted thereafter; and explanations of whether any outliers (data points or entire experiments) were eliminated and when the rules for doing so had been defined.
 
Importantly, Molecular Pharmacology has established a dedicated review process for each manuscript received to check compliance with the new guidelines. This is in contrast to JPET and DMD, which do not have similar policies in place (yet).
 
It will be interesting to analyze the impact of Mol Pharmacol’s additional review of manuscript and guideline compliance after a certain period of time.
Indeed, Anita Bandrowski and colleagues have recently shown that identifiability of research tools like antibodies was dramatically improved in journals like eLife and Cell since 2015/2016 compared to e.g. PLOS ONE. The reason identified was that both journals (eLife and Cell) not only changed their guidelines to make them more visible but also proactively enforced them. PLOS ONE also changed their ItA to improve how they describe research tools, but without the same level of active enforcement.
 
We do hope that the ASPET’s new instruction to authors will have a positive impact and will set an example for other journals and learned societies to follow. We also hope that the efforts by ASPET will further demonstrate the role of enforcing the guidelines and instructions.