P4C—R&D Remodel: Building Trust and Changing the Culture in Research
During this session, moderator Kathy Hudson asked panelists to identify some of the barriers that prevent the culture of research from being a culture of innovation, what some of the solutions may be, and, in a changed culture, what the field will be empowered to do and achieve. Panelists Jason Bobe, Matthias Evers, Allan Jones, Richard Pops and Kaitlin Thaney provided diverse answers from several of the many sectors at play in this ecosystem.
Hudson suggested that many barriers are formed by traditionalism or a “the way we’ve always done things” mentality. In her experience at the National Institutes of Health (NIH), many methods of operation are said to be founded in the law, when in reality there is only a decades-old memo or no evidence of the reasoning for operating that way. An exceptional area in which traditionalism is holding back the field is in data sharing, not only among scientists but also among scientists and research participants. For example, 60 percent of clinical trials completed more than 2 years ago have not published their results or made them publicly available. This culture of hoarding data and results while waiting for publication prevents patients and other researchers from learning about current endeavors and building upon innovative, sound science.
Thaney, who has worked on openness and access issues throughout her career, noted that the biggest issue holding back data sharing is the lack of a participatory framework to support development of better data-sharing practices. In her experience, maybe one or two individuals are tasked with effecting such a culture change in an organization; however, what is needed is overwhelming buy-in and mapping of how the culture change will be operationalized in the everyday activities of the organization and individuals.
Kaitlin Thaney, director of Mozilla Leadership Networks
Pops declared that the largest risks are those necessary to develop new drugs and that failure in biotech is punished. Earlier this year, Pops’ company, Alkermes, reported on the failure of two drugs in development, resulting in a 60 percent decrease in stock prices in just one day. He said this intense reaction to so-called “failure” was unfounded because Alkermes gained valuable information about these drugs, even though they would not make it to market. Pops said that risk-taking needs to be embraced for the benefit of patients because drug development is “not really for the faint of heart.”
Looking to learn from other scientific fields with a culture of openness, Jones pointed to the physics community, which has developed a strong culture of sharing. He echoed the opinion that limited data sharing is a major barrier, and added that sharing of three essential resources is needed for medical research: the data itself, reagents and resources, and information and knowledge. Jones noted that resources for data sharing are often the first to be cut from budgets and that the Allan Institute has collaborated with partners for distribution of mice and cell lines in an effort to share those valuable resources with the scientific community. He finished his comments by saying, “We still have a problem with our vital work product, which is knowledge, being behind paywalls,” a sentiment echoed by others throughout the session.
Jason Bobe, executive director of PersonalGenomes.org
Evers began by stating that hope should not be lost: we’ve seen progress in collaboration and culture change, we can see the light at the end of the tunnel, and innovation is coming our way. He quickly broke down the largest barriers to collaboration into four areas: a snobbish attitude in scientific fields, the need for an impact mindset, a lack of risk taking, and a closed information system. He made this suggestion for change: “For every piece of research, ask if this will have relevance for the patient,” which will create an impact mindset and focus researchers on generating innovation, rather than satisfying themselves with incremental progress.
Bobe focused on what he terms the Participation Paradox: If you ask people what they care about, they will say health is at the top of the list, but participation in research is extremely low. He is working on creating health research experiences that individuals are excited to be involved in, because “research is a first step in solving the health issues of our families and communities.” Bobe noted that a patient-centered research approach requires more than just good science, and today’s scientist are not poised to provide this. Staying engaged with patients and designing a study around the needs and values of participants places a significant burden on design.
Hudson explained that this was a critical consideration during development of the Precision Medicine Initiative Cohort Program All of Us, for which all research questions must be founded in sound scientific evidence and either build or not erode trust with the experiences that participants are receiving. Other panelists echoed the value of building and sustaining relationships with research participants to capture data that are relevant to their disease areas. Pops highlighted an example of developing parallel tracks of more naturalistic experiments for depression to better understand the taxonomy of mental health conditions.
In the closing minutes, Hudson granted each participant an imaginary magic wand that could change one aspect of the R&D ecosystem and asked what change they would create. Thaney chose to use her magic on building capacity for scientists to develop essential skills for researchers, including design thinking, data-sharing practices and patient engagement. Pops’ focus was to build a strong, well-funded regulatory system with the best and brightest in the field cycling in and out. He noted that porosity throughout the system is important because of the central role that regulators play in getting medications to patients. Evers said that efforts to align the goals and actions of the public and private sectors could make a lasting impact on culture change. Breaking up the monoculture of academic medical science was Jones’ choice for his magic wand. He added that researchers fear going to an institution that conducts research differently, which could affect their ability to return to academia. Encouraging more research institutions to try innovative ideas would push the field forward. Finally, Bobe highlighted the federally protected right for individuals to access their health records, which should also apply in research settings.
If these magic wands really did exist, it is clear that the culture of the biomedical R&D ecosystem would change for the better. However, in their absence, concerted efforts to spread innovation and adoption of new practices throughout the sectors must continue to bring impactful culture change to this field.