Source: BioSupply Trends Quarterly
CLINICAL TRIALS are the linchpin for bringing new medications to market, and they depend on patient participation. However, stalled patient recruitment is a significant, ongoing problem that leads to unwanted trial delays. In fact, a recent review and meta-analysis of online patient recruitment for clinical trials revealed that patient recruitment is the primary cause of trial delays. “Around 80 percent of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as $8 million per day for drug developing companies.”1
The extent of the problem is no secret. According to Attila A. Seyhan, PhD, director of translational oncology operations at the Cancer Center at Brown University, “The crisis involving the translation of basic scientific findings in a laboratory setting into human applications and potential treatments or biomarkers for a disease is widely recognized both in academic and industry.”2 Harsha Rajasimha, PhD, founding member of the Organization for Rare Diseases in India, concurs. In fact, Dr. Rajasimha revealed that the difficulty of getting candidate drugs approved by the U.S. Food and Drug Administration (FDA) is so well-known that the regulatory review process is colloquially referred to as the “Valley of Death.”
“The FDA’s process averages about seven years in the clinical development phase, but for a total of 12 to 15 years, with only an average of about one out of every 10 candidate drugs, or 12 percent of the candidate drugs, actually receiving regulatory approval and making it to market,” Dr. Rajasimha explained.3 Further, the process is also very expensive. “It can cost over $2.5 billion to bring one successful candidate drug to market because pharmaceutical companies have to underwrite the cost of the nine drugs that failed to receive FDA approval,” he added. “The burden of getting that one successful drug to market means that there are nine potential failures before that happens.”³
Further, travel and logistical burdens, restricting search to a five-mile radius of selected investigator sites due to expectation of in-person visits each time, high screen failure rates demanding higher number of potential subjects, and effort involved for participants during the active period of the clinical trial all cause costly delays in clinical trials.
To solve the mulitfaceted challenge of addressing clinical trial delays and getting more drugs to market, patient recruitment needs to be accelerated. And, software developers may be part of the answer: They have entered the digital health technology space to address the challenges of online patient recruitment so pharmaceutical companies can efficiently start and successfully complete their clinical trials. Here are three companies that are working to help pharmaceutical companies accelerate clinical trial patient recruitment.
Jeeva Clinical Trials Inc.
Jeeva Clinical Trials Inc. is a clinical trial software company that developed the Jeeva eClinical Cloud, a software as a service (SaaS) platform driven by artificial intelligence (AI), to accelerate clinical trial timelines, electronic data capture efficiencies and remote clinical outcome assessments of participants in therapeutic areas such as oncology, rare diseases and chronic conditions by eliminating the bottlenecks commonly found in the clinical trial process.
According to Dr. Rajasimha, who is also the founder and chief executive officer of Jeeva Clinical Trials Inc., “The Jeeva eClinical Cloud platform effectively tackles the challenges of patient recruitment and retention in clinical trials through a multifaceted approach integrated into a single modern technology platform. It expedites patient recruitment timelines by three times while cutting costs by 50 percent and minimizing user burden by 80 percent. With an integrated calendar scheduling system, Jeeva minimizes the risks of missed participant appointments and the burden of appointment management.”
This is achieved with:
- Streamlined processes. Restructuring configuration of study databases, enabling rapid remote eligibility screening, and facilitating electronic informed consent, electronic clinical outcomes assessments and electronic patient-reported outcomes all contribute to a more efficient process.
- Efficient design. The eClinical Cloud is protocol-fit, disease-neutral, device- agnostic, flexible and modular to support patient-centered, modern clinical trials that are significantly more efficient and accessible to most patients. It was designed for ease of use, efficiency and collaboration among sponsors, and for investigator teams and participants to have real-time access to the same centralized study database.
- Unified platform. The eClinical Cloud allows sponsors to conduct efficient trials at single or multiple centers with central institutional review boards (IRBs) or site-specific IRBs on a unified clinical trial management platform to engage, screen and enroll participants remotely from the convenience of their homes from multiple channels such as social media advertising, online ads, email campaigns, SMS campaigns and other connected networks. With one unified platform, the eClinical Cloud configures versatile trial protocol designs and minimizes manual effort with the ability to make remote clinical assessments, televisits and intelligent automation built into the platform. “The platform supports remote and hybrid clinical research models, allowing for greater flexibility and accessibility for participants. Thus, Jeeva has become a crucial solution for enrolling and engaging diverse patients in clinical studies,” explained Dr. Rajasimha.
- Personalized engagement. The eClinical Cloud enables personalized patient engagement for minimizing drop- out rates, especially in long-term clinical trials. The platform fosters a strong connection with participants, thereby improving patient retention rates. This emphasis on the patient-centric approach contributes to the success of long-term trials, ultimately enhancing the quality and reliability of the research conducted on the platform.
Results are promising. According to Dr. Rajasimha, “Since the Jeeva eClinical Cloud was commercially launched in the fourth quarter of 2021, 16 clinical studies are successfully running on the platform, including one approved CAR T cell/gene therapy for B-cell lymphomas. All clinical trials are renewing year-on-year and new studies are onboarding with confidence as we achieve significant software quality, validation and compliance. Jeeva is thrilled to note that all clinical studies are achieving their patient enrollment goals and are well-positioned to be completed successfully.”
Looking Forward
According to Dr. Seyhan, some progress has been made across the preclinical and clinical divide. Pharmaceutical companies are now using open innovation models to address research and development challenges; a new breed of pharmaceutical companies from emerging economies are using research and development and business models that challenge U.S. and European models; and, perhaps most importantly, using AI in biomedical research and development will affect the future of pharmaceutical research and development.2
In fact, Rejuve Biotech Chief Executive Officer and senior biologist Kennedy Schaal says that AI in biomedical research is revolutionizing drug development and clinical innovation by predicting clinical trial outcomes. “AI algorithms can analyze data from past trials to predict the outcomes of new clinical trials better. This can help improve trial design and recruitment.”4
If pharmaceutical companies can solve their clinical trial delays by accelerating patient recruitment and retaining their participant population throughout the trial process, more drugs could potentially be more successful in surviving the Valley of Death and go on to receive FDA approval. This would result in more drugs becoming available to more patients in a timelier manner to treat or cure their illnesses and diseases.
