Evidence-based medicine has proven its worth. So, how do we now apply it to toxicology?
Get the right people talking together about a problem and you might come up with a new approach, if not a solution. That is the idea behind InnovationWell, Douglas Connect’s new Knowledge Café. “Informal conversation may be the best technology ever invented for sharing knowledge,” says Dr. Barry Hardy, CEO, Douglas Connect. “It’s a great way to spark new thinking about old problems.”
For one of its first InnovationWell events*, Douglas Connect chose one of the most taxing – yet, promising - issues facing the toxicology community: How can we apply evidence-based medicine to toxicology?
For the InnovationWell event at Cambridge on May 11, two heavyweights in the toxicology community opened the discussion by presenting the facts to date. Dr. Katya Tsaioun, Director, Evidence-based Toxicology Collaboration, Johns Hopkins Bloomberg School of Public Health, spoke about the history of evidence-based medicine. Dr. Kris Thayer, Director, of the EPA’s Integrated Risk Information System (IRIS) Division, followed with a portrait of Systematic Review and how it works in the regulator field. Full presentations are available here.
Big question for 21st Century toxicology
Dr. Tsaioun explained the origins of Evidence-Based methodology in clinical medical trials and how the Cochrane Collaboration took the methodology to the next level. “The Cochrane Collaboration made Evidence-Based methodology the standard in the pharmaceutical industry,” she explained. “In 10 years, from 1993-2003, the failure of drugs due to pharmacokinetic (PK) reasons dropped from 40% to 7% because large pharma started en masse doing high throughput screenings ADME. Can we do the same with toxicity?”
The Cochrane Collaboration has had tremendous impact on clinical medicine. The problem, Dr. Tsaioun said, is transfering what has been learned for medicine to toxicology. “When you start doing systematic reviews in the toxicology space, you quickly realize that there actually are no methodologies, or that some of the methodologies developed under clinical trials are not applicable or have to be significantly adapted.”
To improve reproducibility, systematic reviews are needed across the board, she added. “Look at the literature and you see missing data, incomplete methodologies and lack of primary data. So, there is a lot of work to do.”
The video below is a discussion between Barry, Kris, and Katya on supporting community initiatives concerning data and trust. The full list of recordings from our May webinars is available here.
Study the studies
Taking up this theme, Dr. Kris Thayer followed with an explanation of how the Systematic Review process brings transparency to analysis. “The idea of Systematic Review is that your criteria for study eligibility are transparent and clear enough that someone else can understand them.”
As a study of studies, she added, Systematic Review puts a premium on being clear about the method. “When you start a Systematic Review, you ask: What is the question? What is the decision-making context? You also do problem-formulation: Has somebody else already done the assessment? Can I build on somebody or do I have to start from scratch? So, you have this whole process of trying to focus your question. And, through that process, it starts to set up how you are going to find studies to address your question.”
Dr. Thayer laid out the complexities of the process, both technological (“Electronic data capture for full-text is really hard, even for simple content and especially when you’re thinking about content that might help you get quality.”) and human (“If we could just agree on common terminology…”), but she also demonstrated the promise. “When you encourage the field to collect information in this way, it’s more accessible, it’s easier to look at patterns, and it’s shareable. When we finalize an assessment, we would make available an extraction in a way that, if you wanted to do quantitative analysis on it, then it’s set up that way.”
Coffee and conversation
After the two presentations, Dr. Barry Hardy opened the floor for questions and, then, participants broke into small groups, with Dr. Thayer and Dr. Tsaioun rotating between the tables.
Frank Hollinger, Douglas Connect: Your impressions: Any ideas or anecdotes that came out of discussion at the tables?
InnovationWell hopes to catalyze progress on this important issue, as well as other important areas in the toxicology field. But Dr. Tsaioun reminds us of the size of the undertaking. “It took us 30 years to reach the Cochrane Collaboration. In toxicology, we are just at the beginning of the process.”
*In May, Douglas Connect relaunched its Knowledge Café, InnovationWell, with three events in the US at three different sites: Bryn Mawr College in Philadephia, Cambridge Innovation Center in Boston and Frontier Park in the Raleigh-Durham Research Triangle. “We chose these locations because all three have an important concentration of experts in the toxicology field,” says Dr Barry Hardy, CEO, Douglas Connect.
Subsequent articles here will focus on the issues discussed at the other two events in Philadelphia and Raleigh-Durham. During October 2018, Douglas Connect will hold three new InnovationWell events at the same locations. In addition, it will launch events in Amsterdam, Munich and Basel also in October.