Kate Heffernan, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Boston office, was featured Clinical Leader, in “3 Clinical Research Attorneys Talk 2026 Trends,” by Abby Proch.
Following is an excerpt:
2025 was a year of fast-paced change for science and clinical innovation, with both positive and negative consequences. 2026 brings the opportunity to embrace new trends that work and to say goodbye to those that did not. Trends clinical research should "say goodbye" to in 2026:
- An expectation of the availability of federal funding. If there was one theme for clinical research in 2025, it was a constriction in the federal funding that supports both the upstream early development of funding as well as clinical trials. In 2026, a resurgence of creative partnerships between industry and academia (and healthcare investors) should be explored to ensure continued diversified resources to support scientific innovation.
- Administrative inefficiency. In the new year, clinical research should lean into AI solutions to reduce the need for human capital expenditure on purely administrative and systems operations, both to allow for increased focus by research teams on the strategy and execution of the research, as well as to reduce the cost of trials. Identifying those tools that strike an appropriate balance between introducing efficiency and maintaining appropriate human involvement (the "human in the loop") will be key to the successful deployment of these new technologies.
- Lack of reproducibility and/or scientific integrity. 2025 (and the preceding five years) saw an unprecedented number of allegations of data manipulation (falsification and fabrication) in the published literature, fueled in part by online "integrity sleuths" deploying AI tools to search the literature for image duplications. While the uptick in public allegations certainly does not necessarily establish an uptick in problematic research practices, there has been an ongoing national (and international) conversation about the lack of reproducibility in science, including remediation efforts promoted by the NIH and other international organizations. With the Office of Research Integrity's new regulations on research misconduct becoming applicable on January 1, 2026, the time is ripe for the research community in the United States and abroad to work collectively to elevate the culture of research data integrity and validity.
People
- Board of Directors / Member of the Firm