As patients across the globe clamor for new therapies, research into why treatments take so long to develop invariably highlights the deep-seated inefficiencies of the drug development process.

There have been great strides in technology implementation, but product development is still constrained by stubborn bottlenecks often linked to study startup (activities that occur before a study begins) — widely considered the leading cause of long cycle times, which have stagnated for the past 20 years.

Drug development is a brutally competitive industry, with the total capitalized cost of developing a successful new drug exceeding $2.5 billion. The bumpy road to new therapies is littered with failures, but every once in a while, individuals and groups with passion, drive and a fierce commitment to innovation bring a new perspective that moves the needle.

Why Innovation Is Necessary

Study startup is the foundation and starting point of clinical trials. Too often, if a study is improperly started, it requires “rescue,” which is the costly practice of adding more investigative sites to complete enrollment targets. This is a big challenge as an estimated 80% of clinical trials fail to meet enrollment timelines. This degree of inefficiency leads to a 94% rise in study timelines.

Given this tough scenario, it’s time for innovators who understand the business of clinical trials and have a passion for change to step forward and bring new innovations to the table. Here are some of the ways I believe we can achieve this:

• Anonymization of electronic medical record (EMR) data using blockchain technologies to improve access to targeted patient populations based on study protocols

• Adoption of “best of breed” eClinical applications with integrations based on open industry standards