How to Increase Clinical Trial Success Probability with Efficient Designs

Deepak Khatry
Deepak Khatry discusses devising optimal strategies for increasing the probability of success in clinical trials.

Clinical trials are expensive propositions with high failure rates. In fact, only 1/4 of trials progress to Phase 3, and the cost of bringing a drug compound to market can range between nearly $1 billion to $3 billion. To reduce costs and increase success probability, more efficient clinical trials must be designed, says Deepak Khatry, Ph.D., a Westat Biostatistics Lead and Associate Director for Clinical Trials.

“For years, I’ve been devising optimal strategies for increasing the probability of success in clinical trials by using carefully chosen clinical endpoints, often matched with appropriate biomarkers and diagnostics,” says Dr. Khatry. “And I can report that an expedited, optimized study with these factors is essential to ensuring clinical trial efficiency.”

Dr. Khatry says the first step in the design process is clearly understanding how the drug works and what the appropriate clinical endpoint should be. Next the margin of clinically meaningful difference must be determined to demonstrate the superiority, equivalence, or non-inferiority of the new drug versus the standard of care, depending on the type of study design to be used. That margin of difference must be acceptable to clinicians, patients, and regulators such as the U.S. Food and Drug Administration (FDA), he adds.

“Appropriate biomarkers and diagnostics can assist in stratifying patient subsets and in choosing optimal statistical methodology and tools,” says Dr. Khatry. “Identifying the right statistical methodology and tools will ensure robust data analysis for evidence generation, interpretation of study results, and communication of study findings. Other factors we consider are the required sample size, which will affect the trial’s length and cost, and how best to recruit participants.

“Also, to increase success probability, part of the design is to run computer simulations of the studies to ensure that they are adequately powered to succeed with the sample sizes proposed and they are using realistic assumptions related to the chosen clinical endpoints,” explains Dr. Khatry. “The computer simulations provide assurance for trial success. Where relevant, Westat builds in provisions for interim analysis of study data to allow us to increase study sample size if necessary to maintain study power for success.

“When clinical trials are efficiently designed and conducted, they are less costly and promise a higher success rate,” continues Dr. Khatry. “This means the drug can come to market sooner, and insurance companies are more likely to pay for it. It’s a win-win for the patient and all stakeholders.”

When clinical trials are efficiently designed and conducted, they are less costly and promise a higher success rate.

- Deepak Khatry, Ph.D., Associate Director, Clinical Trials

Want to work with us?
You’ll be in great company.

About Us Careers

Westat Employees.
Westat Employee.
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Substance Abuse and Mental Health Services Administration
The National Institutes of Health
AAA Foundation for Traffic Safety
The Johns Hopkins University
University of Maryland Baltimore Campus
University of Denver
U.S. Department of Veterans Affairs
U.S. Department of Transportation
U.S. Department of Justice
U.S. Department of Health and Human Services
U.S. Department of Education
U.S. Department of Agriculture
Toyota
The Verizon Foundation
Texas Education Agency
Baltimore Metropolitan Council
Teach for America
Social Security Administration
SiriusXM
Robert Wood Johnson Foundation
Organization for Economic Cooperation and Development
NYC Mayor’s Office for Economic Opportunity
National Science Foundation
Michigan Department of Health and Human Services
Maryland Cancer Registry
Internal Revenue Service
Georgia Department of Transportation
DC Public Schools
ClearWay Minnesota
Chicago Metropolitan Agency for Planning
University of Michigan
Explore Our Clients

Please wait...

Forbes 2020 The Best Employers for Diversity Powered by Statista Copyright 2019 Forbes Media LLC. Used with permissionForbes 2019: The Best Employers for Women Powered by Statista Copyright 2019 Forbes Media LLC. Used with permission

Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law. Notices to Employees & Applicants.