Assessing How Companies are Transitioning from Legacy, High Frequency to Risk Based Study Monitoring
In June 2023, the Food and Drug Administration issued a draft guidance for greater support of risk-based monitoring (RBM) / risk-based quality management (RBQM) – a systematic approach to managing the quality of clinical trials – throughout clinical trial planning and execution. Despite the increasing integration into clinical trial practices over the past decade, there is limited understanding of RBQM adoption across drug development.
Tufts CSDD is conducting a new study aimed at understanding how study monitoring and data management practices are changing and evolving. We are also looking at how sponsor organizations are approaching implementation of more centralized, adaptive, or risk-based monitoring approaches and how field-based monitors from sponsor and CRO companies are adjusting and adapting. We invite you to participate in this important new study.
As a thank you for your participation, we will share a special report on the benchmark results. As always, Tufts CSDD will also look to publish the study findings in peer-reviewed journals and in the trade press. Thank you in advance for your participation in this important research effort!
We plan to share the results widely with sponsors and clinical research associates to help inform decisions on how to adapt their practices, in part in response to ICH E6 (R3) and E8 (R1) guidelines. Thank you in advance for your participation in this important research effort!
Please also feel free to share the survey links with your network.
If you have any questions, please email Hana from the research team at @email.
Examining Barriers to Becoming a Physician Scientist Survey
Physician-scientists are crucial for translating scientific discoveries into medical advancements, but their numbers have been declining over recent decades, limiting innovation and clinical research. Physicians, particularly minority physicians, face a range of barriers, including financial constraints, lack of mentorship, systemic challenges, and underrepresentation. These obstacles hinder career progression and perpetuate a lack of diversity and equity in the field. Minority physicians, in particular, struggle to take on principal investigator roles in clinical research, including clinical trials funded by the pharmaceutical and biotechnology industries.
The study led by Tufts CSDD, aims to identify and address the drivers and barriers minority physicians face in entering research careers. By examining their unique challenges and experiences, this research will contribute to the development of new policies and approaches to improve minority physician involvement in clinical trials and research. Ultimately, the study seeks to foster a more diverse and inclusive physician-scientist workforce, strengthen the pipeline for future researchers, and promote health equity in both research and patient outcomes.
If you have any questions, please email Madison from the research team at
@email.
Examining the Impact of Racial Colorblindness Among Healthcare Professionals on Enrollment of Racial Minorities in Clinical Research Studies
Racial minorities in the United States (U.S.), despite making up more than 30% of the population are critically underrepresented in clinical trials. Black Americans, despite representing 12% of the population only made up 3% of the study population, while Asian Americans, a group that is often assumed to be overrepresented, only comprised 1% of pivotal drug trials in the U.S.
One contributor to the lack of racial representation is racial bias among gatekeepers – referring clinicians - who play a pivotal role in referring patients into clinical trials. Racial bias towards racial minorities can hinder decision-making processes, reducing the perceiver’s perception of trust, likeability, and competence of the target. These forms of racial bias are also likely to manifest in clinical research and affect the quality of healthcare patients receive. One common form of racial bias is racial color-blindness – “explaining racial matters as the outcomes of nonracial dynamics,” failing to recognize how racial minorities are discriminated against. This view fails to acknowledge the additional burden that racial minority communities face.
This study examines the impact of racial color-blindness on the enrollment of racial minority patients, demonstrating how racial bias can contribute to the racial disparity in clinical research. Study findings will inform clinical research stakeholders, including policy makers, on ways to reduce racially-color blind attitudes that can hinder equitable enrollment of racial minority patients.
If you have any questions, please email Madison from the research team at @email. 