Biggest Risk Factors for Emerging and Mid-market Biopharma Companies, Costly Clinical Trial Delays

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.


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