Phase 2 clinical trials are of vital importance in the drug development process as they usually gather preliminary evidence of efficacy of potentially new therapies and support the go/no-go decision for Phase 3 pivotal trials. Topline results of Phase 2 trials are typically first disclosed through press releases so that key stakeholders (patients and their advocacy groups, physicians, clinical trials practitioners, investors, etc.) can have timely access to a high level summary of the important findings. The sponsors of the trials often will save more detailed findings for future medical conference presentations and/or peer-reviewed journal publications, and as a result there may be an extended period of time where only the topline results are available on which stakeholders can rely. It is therefore critical for trial sponsors to release objective findings and avoid selective disclosure of favorable results.
Press releases for Phase 2 clinical trial topline results: Have the objective pre-specified efficacy results been disclosed?
Message from Deerfield Managing Partner, James E. Flynn
Over the course of the last few months, images of unimaginable human loss in the midst of a pandemic have been continuously in front of us. The impact, however, has not been evenly distributed. Here in Upstate New York, over 17% of the deaths from Covid-19 have been among Black people, despite the fact they represent less than 10% of the population.
These data serve to highlight the deep biases that remain embedded in society that relate to access to care. The imbalance in the composition of leadership and boards of healthcare companies demonstrates clearly that this bias is just as strong when considering access to opportunity.
Recent disturbing acts of violence have brought added focus to how Black people and other minority groups are treated, even in the hands of those whose job it is to protect. While these acts have gained greater attention in recent weeks, partly because of the outrage expressed by people of every demographic, each day there are uncountable acts of this nature that go unnoticed.
We must capture this moment of raised awareness and heightened energy to effect real change. We must do better. Not only because we have to, but because we want to.
At Deerfield, we are strong advocates for diversity of backgrounds and ideas, and we are deeply committed to maintaining an inclusive work environment for people of all races, ethnicities, genders, religions, and sexual orientations.
Through our Deerfield Fellows program, we have proactively engaged a diverse group of students from the City University of New York (CUNY) to create opportunities to learn about careers in healthcare finance and entrepreneurship. We now count many of these talented individuals as our colleagues.
Through the Deerfield Foundation, we’ve made investments that address the social determinants of health in communities of color, both here in the U.S., as well as in Africa and Asia. In addition, we have created Break into the Boardroom and Women in Science programs to drive change in gender diversity in the boardroom and entrepreneurship.
However, we, too, must do more, and will. We believe that providing platforms for the voices of a diverse set of stakeholders introduces new, and better ideas. And in the case of healthcare, it could spark more inclusive and creative solutions to the industry’s complex set of challenges.
We must address society’s social inequities, including in patient care. We must partner with our local communities in the fight against racism and other injustices. We must acknowledge the pain, grief, and fear that many families are feeling now, and we must listen to those families. Only then can we begin the path toward sustained structural change and healing.
The times ahead will be tough, as our nation continues to face many public health, economic, and social challenges. Despite these challenges, we must find a way to use this time of despair as an opportunity to come together and create solutions.