Patient-Centric Approach to Clinical Trials Improves Outcomes for All Stakeholders

TYSONS CORNER, Va. (PRWEB) September 20, 2021 — Clinical trials of new drugs and treatments have a high failure rate. Better planning and technology-aided communication, says Dr. Harsha Rajasimha of Jeeva Informatics, can significantly reduce the number of participants who drop out, thus improving the chances of success—for the trials and the therapeutic product itself.

According to researchers at the MIT Sloan School of Management, the probability of FDA approval of an industry-sponsored drug entering Phase One of the clinical trial process is 13.8%(1). A major factor in a trial’s success or failure, notes Dr. Harsha Rajasimha, founder and CEO of Jeeva(TM) Informatics, is the trial sponsor’s ability to recruit and retain patients. Current statistics show that 85% of all clinical trials are delayed during patient recruitment, and 30% are terminated early due to failure to recruit enough patients. Those small proportion of trials that do enroll the required subjects experience 30% dropout rate on an average.(2) “This is bad news,” says Dr. Rajasimha, “not just for the sponsors of these trials and the participants, but for a world in serious need of new and better tools to fight disease.”

Improving the success rate of clinical trials, says Dr. Rajasimha, is an urgent matter on every level—recruitment, retention, testing, diversity and educating the patient, among others. The U.S. National Library of Medicine, he notes, currently lists 388,959 studies in progress, with locations in all 50 states and 219 countries.(3) While expenses vary from study to study, the estimated cost for bringing a clinical trial through all phases to FDA approval ranges from $44 million to more than $100 million.(4) However, according to Dr. Rajasimha, that number could actually reach into the billions of dollars.(5)

Missed opportunities
On the human and medical level, the loss incurred in a failed or canceled clinical trial can be significant. The U.S. Clinical Trial database, for example, has recently released a list of more than 50 clinical trials that were suspended or terminated during the year between April 1 of 2020 and March 30 of 2021. Among them were studies focusing on:

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