The landscape of drug development is fraught with escalating costs and formidable challenges. Lengthy timelines, exorbitant expenses, and regulatory hurdles often impede progress, hindering the timely delivery of life-saving treatments
CLINICAL TRIALS are the linchpin for bringing new medications to market, and they depend on patient participation. However, stalled patient recruitment is a significant, ongoing problem that leads to unwanted
In recent years, transformative strides in the treatment of sickle cell disease (SCD) have materialized with the FDA’s approval of groundbreaking cell-based gene therapies. Notably, in December 2023, the FDA
In the fast-paced world of biopharmaceuticals, emerging and mid-market companies face significant challenges when bringing innovative drugs to market. One major obstacle is the costly delays in clinical trials, which
Gender gaps, with consistent underrepresentation of females, present a substantial challenge in clinical research.1 Achieving a balanced representation of both genders has proven exceedingly difficult, necessitating solutions to address this
Patient recruitment is a major barrier in clinical trials. This involves the identification of patients, screening them for inclusion/exclusion criteria of a given clinical trial, and enrolling eligible patients into
Patients’ directly reported outcomes in certain rare and chronic diseases are considered reliable for understanding the disease’s natural history, palliative treatments that focus primarily on symptom control, and quality of
Clinical trials (CT) are the long and complex processes for bringing novel medical products to patients through the regulatory process of evaluating the safety and efficacy of treating specific medical
The COVID-19 pandemic brought a new sense of appreciation for clinical trials as masses watched clinical trials closely while pharmaceutical companies raced against the clock to find viable vaccines and
Traditional clinical guidelines, and stand-alone patient study and care pathways are proven to be increasingly inadequate, especially in a post-pandemic world with low clinical adherence, disrupted workflows, and stay-at-home orders. Disrupted
Disparities related to diversity, equity, and inclusion (DEI) are common and well-known in clinical trials. It is well-documented that racial minorities, underprivileged, and non-white ethnic groups are much less represented
Evidence linking interventions with health outcomes is vital for healthcare decision-making. Making sound choices about healthcare requires the best possible and quality evidence from clinical research. However, some of the
