The entire research, development, and approval process of a new drug by the Food and Drug Administration (FDA) can range between 12 to 15 years.
Drug companies seeking to sell a drug in the U.S. must first test it and then send it to the Center for Drug Evaluation and Research (CDER), following which a team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling, and subsequently approves the drug if the benefits outweigh the risks. After approval, the researcher can begin clinical trials on volunteers.
Phase 1 trials determine medication safety and dosing in 20-100 individuals, while Phase 2 trials assess safety and performance in several hundred individuals. Phase 3 trials further assess safety, performance, and side effects in 300-3,000 individuals. Only about 25% of medications move forward in the FDA approval process after Phase 3 trials.
“There are several persistent challenges and pitfalls in bringing new drugs to the market. For proper planning and risk mitigation, 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,” says Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, a company that specializes in significantly accelerating the process of bringing new medicines or vaccines to patients who need them.
Based on studies, patient recruitment issues are the cause of 85% of clinical trial delays, with 80% of trials being delayed by at least a month. Each day of delay potentially costs between $600,000 and $8 million in lost revenues.
Clinical trial recruitment faces several challenges at the site level, such as outdated patient databases, and failure to enroll patients because of complex eligibility criteria. Other challenges include unqualified or unresponsive patients, patient location, and lack of interest.
“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. Clinical Trial operations need to be focused on the right aspects at the right time, especially up front,” explains Dr. Rajasimha.
Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics can speak on the following:
- What are the different phases of the drug approval process by the FDA?
- What are the challenges in bringing new drugs to market?
- What are the persistent challenges faced in clinical trials for the testing of drugs?
- What are the factors that affect clinical trial recruitment and participation?
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/
To speak with Dr. Harsha Rajasimha, contact me via khelms@jotopr.com or call 727-777-4619
Media Inquiries:
Karla Jo Helms
JOTO PR™
727-777-4619