We offer tailor-made diversity solutions to sites and Sponsors/CROs. Some of our services include Diversity Plans, remote Spanish and Creole speaking CRCs, translation of study materials to Spanish, and access to a highly diverse patient population.
Increasing diversity in clinical trials is a critical priority for the pharmaceutical industry and for government regulators. Ensuring that trial data properly represents the demographics of the consumer market has become more important than ever.
At MplusM Consulting we are strongly committed to increasing diversity in clinical trials and in making trial participation more representative of the country’s population. Having a more diverse trial population ensures that a trial’s efficacy is improved and potentially identify effects on safety or efficacy that may occur more frequently in these populations.
Participation of ethnic and racial minorities in clinical trials is still well below their share of the population in the United States. In some therapeutic areas like oncology, participation of ethnic and racial minorities is lower than half of their share of the percentage of their population in the United States.
Having quick turnaround times is a critical part of our business and we offer a guaranteed 48-hour turnaround time for Feasibility Questionnaires (FQs) and a guaranteed one week turnaround time for Budget and CTA negotiations.
To address this disparity in diversity in clinical trials, we work in close collaboration with our research sites to develop their diversity strategies and specifically assist them in two critical areas:
Individuals from diverse racial and ethnic populations in the United States are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.
A fair representation of these diverse populations helps ensure that the data outcomes from a clinical trial reflect the racial and ethnic diversity of the expected to use the medical product that is being tested. Unless a more diverse population is represented in clinical trials, we will not be certain about a medical product’s safety and efficacy with these underrepresented populations.
Our Diversity Plans help your site meet your study diversity targets. Increasing diversity in clinical trials is a top priority for the FDA and the pharmaceutical industry.
We offer sites remote Spanish speaking CRCs that can help them communicate with diverse patients and improve their enrollment.