The value of life-saving drugs for patients suffering from serious diseases is priceless. But the current economic environment is stifling the biopharmaceutical pipeline of up-and-coming clinical trials. Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics and the visionary behind Jeeva eClinical Cloud, appreciates the significant innovations that emerging biotech companies bring to the pursuit of early clinical development of novel therapeutics. He recommends an active front-loading strategy to maximize operational efficiency of clinical trials
TYSONS CORNER, VA. (PRWEB) APRIL 25, 2023
Aspirin, the original wonder drug, and its use as an analgesic and fever reducer can be traced back to 500 BC. Over the decades of the 20th and 21st centuries, the U.S. Food and Drug Administration (FDA) has approved the use of aspirin to manage and treat several health conditions, including in the prevention of strokes, heart attacks, and colorectal cancer.(1) But the next miracle drug can't come quickly enough for patients suffering from chronic illnesses, cancers, rare diseases, and other debilitating health disorders. In 2022, the FDA approved 37 novel drugs, the lowest number to pass the regulatory rigors of the FDA's Center for Drug Evaluation and Research (CDER) since 2016.(2) According to Deloitte, the cost of the research and development (R&D) of one new drug rose 15% ($298 million) in 2022, to approximately $2.3 billion per therapy among the top 20 global biopharmaceutical companies.(3)
Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics and Jeeva™ eClinical Cloud, understands the persistent challenges and pitfalls of bringing new drugs to market. "For proper planning and risk mitigation," Rajasimha says, "the clinical trial operational strategy needs to begin six to nine months BEFORE the trial begins. It needs to be a front-loaded effort to minimize the biggest risk factors first."
Clinical trials comprise 6 to 7 years of the average 10-year span for the successful research and development of a drug from the initial discovery phase to its release into the healthcare marketplace. Unfortunately, less than 12% of candidate drugs make it that far.(4)
While patient enrollment has been historically difficult for Big Pharma, small and emerging biopharmaceutical sponsors of clinical trials are particularly challenged with significantly lower capital to work with when coordinating recruitment efforts.
In order for emerging pharma and biotech companies to achieve more with less money and resources, they need to begin by recognizing and addressing the biggest risk factors first. Studies indicate that 85% of all clinical trials are delayed due to difficulties with patient recruitment.(5) With an average dropout rate of 30%, each day of delay can cost approximately $600,000 to a staggering $8 million in indirect cost of the lost revenues of the drug/biologic/device.(6)
Some common barriers to patient recruitment and retention are:
- a lack of awareness and disjointed communications;
- too narrow inclusion and exclusion criteria; and
- logistical burdens for participants, such as the distance and frequency of travel to investigator-site.(7)
Clinical trial decentralization, when implemented right, has been instrumental in accelerating the recruitment process, increasing enrollment diversity, and encouraging continued participation and patient engagement with reduced burdens.(8)
Dr. Rajasimha cautions, “The risks are highest at the beginning. Persistent pain points plague every clinical trial, such as the inevitable protocol amendments that need to be planned for rather than reacting to them as a surprise—which can exponentially delay the process and increase the costs.”
On average, a clinical trial goes through about 2 or 3 protocol amendments. Such amendments can suspend patient enrollment eligibility, and sponsors and contract research organizations (CROs) don’t often have a plan or budget for them. The Tufts Center for the Study of Drug Development estimates that protocol amendments implementation costs pharmaceutical and biotechnology companies $7 billion to $8 billion annually across phase II and III clinical trials.(9)
Frantz Viral Therapeutics (FVT), a joint venture of Georgetown University Medical Center and Frantz Medical Group, recently selected the Jeeva eClinical platform to effectively execute a multi-site phase 2 clinical trial focused on the treatment of anal squamous intraepithelial lesions (anal HSIL—abnormal cells in the lining of the anus).
“During the different phases of a clinical trial, as we evolve in our knowledge of the product, the disease, and patient population, amendments need to be implemented on a regular basis. [Jeeva] has been able to implement requested amendments to its compliant system within 24 hours.” says Mihaela Plesa, BA, CCRP, Director of Clinical Operations at FVT.
Dr. Rajasimha explains, “Clinical Trial operations need to be focused on the right aspects at the right time, especially up front.”
Jeeva eClinical Cloud helps biopharmaceutical and medical device clinical trial sponsors to achieve more with less money and fewer resources.
To continue the discussion regarding these considerations with clinical research professionals, Rajasimha will be at the ACRP conference at Sheraton, Dallas, TX April 29 - May 1, 2023 and at Philadelphia for the outsourcing clinical trials east conference on May 23, 24.
About Jeeva Informatics
The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology in itself is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company's modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. Visit https://jeevatrials.com/
References
1. Ugurlucan, M., M. Caglar, I., N. Turhan Caglar, F., Ziyade, S., Karatepe, O., Yildiz, Y., Zencirci, E., Gungor Ugurlucan, F., H. Arslan, A., Korkmaz, S., Filizcan, U; Cicek, S. (1970, January 1). Aspirin: From a historical perspective. Latest TOC RSS. Retrieved April 15, 2023, from ingentaconnect.com/contentone/ben/prc/2012/00000007/00000001/art00009
2. Craven, J. (n.d.). CDER approved 37 novel drugs in 2022, its lowest number since 2016. Regulatory Affairs Professionals Society (RAPS). Retrieved April 15, 2023, from raps.org/news-and-articles/news-articles/2023/1/cder-approves-37-novel-drugs-in-2022-its-lowest-nu
3. Philippidis, A. (2023, February 28). The unbearable cost of drug development: Deloitte Report shows 15% jump in R&D to $2.3 billion. GEN. Retrieved April 15, 2023, from genengnews.com/gen-edge/the-unbearable-cost-of-drug-development-deloitte-report-shows-15-jump-in-rd-to-2-3-billion/
4. Pharmaceutical research and Manufacturers of America. (n.d.). Retrieved April 15, 2023, from phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf
5. Stevenson, K. (2022, January 14). 85% of clinical drug trials face delays. what's the true cost? MarketScale. Retrieved April 15, 2023, from marketscale.com/industries/healthcare/85-of-clinical-drug-trials-face-delays-whats-the-true-cost/
6. Mdgroup. (2023, February 16). The true cost of patient dropouts in clinical trials. mdgroup. Retrieved April 15, 2023, from mdgroup.com/blog/the-true-cost-of-patient-drop-outs-in-clinical-trials/#:~:text=Approximately%2030%25%20of%20patients%20drop,to%20non%2Dcompliance%20is%20%2419%2C533
7. PMGroup Worldwide Limited. (2020, November 6). What are the biggest barriers in patient recruitment? PMLive. Retrieved April 15, 2023, from pmlive.com/pmhub/clinical_research/couch_integrated_marketing/white_papers_and_resources/what_are_the_biggest_barriers_in_patient_recruitment
8. Mdgroup. (2023, February 16). Why decentralisation is the future of clinical trials. mdgroup. Retrieved April 15, 2023, from mdgroup.com/blog/why-decentralisation-is-the-future-of-clinical-trials/
9. Tuesday, M. 1. (2022, March 1). Doubling down on protocol amendments and Deviations. Pharmaceutical Outsourcing. Retrieved April 15, 2023, from pharmoutsourcing.com/Featured-Articles/584137-Doubling-Down-on-Protocol-Amendments-and-Deviations/