Communication to Health Institution Leadership
We appreciate this opportunity to deploy a model for achieving Therapeutic Equity for American patients.
Routinely, the racial and ethnic diversity of American patients who are burdened by disease is poorly represented in the clinical trials data that support drug approvals and inform caregivers for the safe and effective use of drug treatments. The consequences of this data shortfall are rarely studied but can be dire. Consequences include ineffective treatment for some patients, prolonged or repeat hospitalizations, and delayed recognition of adverse events that can perpetuate health disparities and negatively impact the quality of patient care. Patients, however, have already spoken on this issue. Surveys indicate most of them recognize the value of clinical trials and the benefits of participation.
While mistrust is always an important issue, the data indicate mistrust is not insurmountable. Furthermore, patients identify their physicians as the preferred conduits through which they receive trustworthy information that can influence their willingness to participate in clinical trials.
It may appear appropriate to assign the responsibility to regulators, policymakers, or global biopharmaceutical industry sponsors for the failure of the clinical evaluation of new medicines to routinely reflect the needs of a diverse American population. However, an important part of the solution may rest not with these entities, but in the trust relationship that exists between patients, their physician-caregivers and the health institutions that often employ them. This trust relationships carries with it significant responsibility for supporting, if not establishing, pathways for providing physicians and patients the essential knowledge and tools that allow them both to exert their best desired influence over the clinical trials processes that impact their daily lives. This requires that physicians gain the knowledge, understanding and current information to share with their patients.
All medical professionals have the mission to deliver the best quality of patient care they can provide. Therefore, all medical professionals who have earned the trust of patients should recognize their responsibility for knowing enough about clinical research to adequately inform their patients. Unfortunately, lack of involvement by many physicians and affiliated institutions inevitably leads to lack of involvement for thousands of underrepresented patients who trust them. This circumstance helps to sustain an unintentional barrier to patient knowledge of trials, limit their well-informed participation, and can thus perpetuate the status quo of health disparities.
In the effort to prepare every trusted physician as an informed resource for patients on clinical research participation, the rapidly changing environment of physicians as employees must be addressed. Over 70% of physicians practicing in the U.S. now do so as employees of a health institution or other corporate entity. Practicing in this capacity often limits their ability to make the decision and/or perform the functions required to participate in clinical trials. Such institutions may be inhibited by the traditional barriers of concerns about loss of patients to clinical trial referrals outside the institutions, concerns about loss of patient trust, lack of recognition of the issues of underrepresentation, concerns for workflow disruptions and allocation of physician time, as well as concerns about actual or apparent conflicts of interest. These same institutions in service to a diverse population will often have the elimination of health disparities as a part of their mission. However, they may be unaware of their role as a barrier to clinical trial participation by the many thousands of patients who trust their physician employees.
We seek the help of individuals, and institutions like yours who share the vision for eliminating health disparities attributable to inadequate clinical trials data. We seek collaboration with those who are willing to work with us to address the institutional barriers and establish the mutually beneficial model for health institution involvement in the pursuit of Therapeutic Equity. Beyond the significant clinical research impact, our model claims utility in educating patients, nurturing the physician-patient trust relationship, and empowering physician and patient influence on clinical research as well as empowering patient self-care. We welcome the benefit of your broad perspective in assuring that the needs of institutions such as yours are met in expediting the integration of inclusive, efficient clinical research into better patient care.
Contact us here to request a meeting.
James H. Powell, M.D., Chief Medical Officer