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Clinical Trials Access Barriers Delay & Derail New Treatments

Clinical trials access starts with awareness. A new white paper from the Global Alliance for Patient Access examines this access issue and the policy solutions to address low enrollment in medical research studies. 

Enrollment Issues

Today, there are more than 400,000 clinical trials underway globally. These trials have the potential to improve health and life quality for countless people. But enrollment challenges can jeopardize patients’ ability to benefit from innovative treatments and cures.

Nearly 80% of clinical trials are delayed, and some shut down, because of enrollment issues. Delays have serious ramifications for patients and researchers alike, the paper notes.

  • Potentially life-saving treatments take longer to reach patients, if they reach them at all.
  • Costs rise for an endeavor that is already expensive. Some estimates place total costs of developing a new medicine at $2 billion – and that’s with no recruitment delays.

With nearly two in five clinical trials reporting under-enrollment, it is critical that stakeholders find ways to improve recruitment.

Roadblocks to Patient Participation

Addressing barriers that complicate participation is a good place to start.

Significant access challenges keep patients from enrolling.

  • Many patients don’t have a clear understanding of what clinical trials are, and patients may have fears and anxiety about trials.
  • Many patients’ primary care providers say they don’t have access to current information about trial opportunities.
  • Patients from historically underserved populations are frequently under-prioritized in recruitment outreach efforts.
  • Participation can be a financial burden to many patients. Patients may still face indirect costs, including lost income from time off work, childcare and out-of-pocket medical costs.

Policy Solutions

Participant recruitment can be aided by policymakers’ support, the paper explains.

Places where policymakers can make a difference include:

  • Making the clinical trial enrollment process more navigable for patients by creating user-friendly online databases and making trial navigators more accessible.
  • Educating primary care providers about clinical trial opportunities and making it easier for providers to match patients.
  • Fostering increased investment in research through public-private partnerships and protection of intellectual property.

Every year, more than $160 billion is infused in research and development for clinical trials. Each dollar represents the promise of better health and life quality for people worldwide. Realizing that promise, however, will require overcoming the barriers that keep patients from enrolling in clinical trials.

Learn more by reading “Clinical Trials Access: Overcoming the Earliest Barrier to Treatment.”

This piece also appeared on the Global Alliance for Patient Access blog.


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