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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)
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:
- new treatments for patients hospitalized with COVID-19 (14 different studies)
- cystic kidney disease
- chronic heart failure
- non-small cell lung cancer
- lupus erythematosus
- lymphoblastic leukemia
- severe pneumonia(6)
The primary cause of trial failure is the inability to demonstrate that a drug or treatment will actually have a positive effect on the condition for which it was developed. A common reason for this inability, explains Dr. Rajasimha, is that the clinical trial had a sample size too small to produce projectible statistics. A recent study of 114 trials in the UK, for example, showed that only 31% had met their enrollment goals.(7)
What is needed, says Dr. Rajasimha, is a new approach, both to study design and patient recruitment. Traditionally, trials have been designed to make it as easy as possible for sponsors to conduct the study. Biotechnology and pharmaceutical companies would communicate directly with the community of physicians involved in the study, who would in turn share information with the patients.
The increasingly popular patient-centric approach turns this model on its head by placing the patient at the center of clinical trial communication. Decentralization of studies based on patient preferences when aligned with the ubiquity of the Internet, smartphones, personal computers, and integrated Software as a Service (SaaS) programs, makes it possible for research teams to communicate directly with the patient base. Another end result is recruiting participants up to three times faster than with a conventional approach, while at the same time lowering the dropout rate.
And minimizing the high dropout rate in certain therapeutic areas, he emphasizes, is essential. “Incomplete data is one of the worst things that can happen in a clinical trial,” he says. “Some data can be covered with a margin of error, but high dropout rates lead inevitably to incomplete data.” Sponsors and sites cannot over-recruit their way out of this problem.
The key to patient-centricity, Dr. Rajasimha notes, is the technological ability to communicate easily with anyone anywhere, on any internet-accessible device. “In developing software for this sector,” he says, “we seek to address patient recruitment, patient retention, and quality of evidence, while adhering to a multiplicity of national and international regulations and guidelines. We strongly believe that this work—as it stands now, and as it develops—will make life easier for all parties concerned and will make a meaningful contribution to the goals for which the clinical testing is intended.”
- Banks, Geoffrey. “Why Do Clinical Trials Fail?” PK / PD and Clinical Pharmacology Consultants, 13 Apr. 2020, nuventra.com/resources/blog/why-do-clinical-trials-fail/.
- “Decentralized Clinical Trials: Are We Ready to Make the Leap?” BioPharma Dive, 29 Jan. 2019, biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591/.
- “Trends, Charts, and Maps.” gov, clinicaltrials.gov/ct2/resources/trends.
- “How Much Does a Clinical Trial Cost?” Sofpromed, 8 Mar. 2021, sofpromed.com/how-much-does-a-clinical-trial-cost/#:~
- Disruption Interruption podcast; Dr. Harsha Rajasimha—Disrupting Clinical Trials—Episode #4 ; disruptioninterruption.com/e/dr-harsha-rajasimha-disrupting-clinical-trials/
- “Search of: Withdrawn STUDIES: Interventional Studies: Adult: Phase 3: Industry: Start Date From 04/01/2020 To 03/30/3021 – List Results.” Home – ClinicalTrials.gov, clinicaltrials.gov/ct2/results?
- Fogel, David B. “Factors Associated with Clinical Trials That Fail and Opportunities for Improving the Likelihood of Success: A Review.” Contemporary Clinical Trials Communications, Elsevier, 7 Aug. 2018, ncbi.nlm.nih.gov/pmc/articles/PMC6092479/.
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