The realm of clinical research is grappling with a major crisis

Introduction:

A patient in their 70s with nonsmall cell lung cancer, unresponsive to chemotherapy and immune checkpoint inhibitors, joined a clinical trial for sotorasib, a KRASG12C inhibitor. This led to a partial response lasting over two years, and sotorasib was later FDA-approved.

This breakthrough showcases advancements in molecular biology and medicinal chemistry, leading to new anticancer drugs. Despite progress, inefficiencies in oncology clinical trials are slowing the development of life-saving treatments and increasing costs.

The slowdown in clinical research, worsened by administrative and regulatory burdens, outdated data collection, and flawed business models, is a national crisis. The Society for Immunotherapy of Cancer (SITC) hosted a summit to address these issues, noting that the COVID-19 pandemic amplified existing problems. Key concerns and solutions were discussed to sustain clinical research.

The Complex Path of Clinical Trial Regulation

Drug approval takes about 8.3 years, with a surge in clinical trials and new anticancer drugs. However, inefficiencies in trial activation, due to complex protocols and regulatory processes, slow down drug development and increase costs. Centralizing review processes and harmonizing regulations across regions could improve efficiency and reduce timelines.

The Flawed Clinical Trial Business Model

The current clinical trial business model is unsustainable and ineffective for patients. Staffing is a major issue, with the number of protocols increasing but not the trained personnel. The COVID-19 pandemic worsened this problem. Most clinical trial staff are trained on the job, with few dedicated educational programs. There is a need for professional pathways in colleges and nursing schools for regulatory science and clinical research careers. Physicians also face similar shortages and inadequate compensation structures.

Clinical research organizations (CROs) often act as intermediaries between sponsors and trial sites, but misaligned goals can lead to longer timelines, higher costs, and slower trial completion. A new model prioritizing speed and quality is needed.

The cost of enrolling a patient in a trial has increased significantly, limiting the scope of research and hindering the development of promising treatments. This is largely due to the flawed business model, trial complexity, slow activation timelines, and inefficiencies in trial conduct and oversight.

Tackling the Clinical Research Crisis

The speed of drug discovery is increasing, with numerous promising first-in-class drugs ready for clinical trials. Technological advancements, like better patient selection using biomarkers, could improve drug development. However, the infrastructure for clinical trials has not kept pace with lab discoveries. Reforming the current system is more urgent than ever. A collaborative meeting led by the FDA, NCI, international agencies, and other stakeholders to streamline clinical research processes should be a top priority.

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