From Protocol to Publication: Reducing Costs and Maximizing Efficiency for Investigator-Initiated Trials

From Protocol to Publication: Reducing Costs and Maximizing Efficiency for Investigator-Initiated Trials

Dr. Harsha Rajasimha, Founder and CEO of Jeeva Trials, highlights the importance and value of Investigator-Initiated Trials (IITs) in gathering real-world data on the efficacy, alternate uses, treatment comparisons, and cost-effectiveness of licensed drugs. Led by non-pharmaceutical researchers in academic settings, IITs benefit doctors, patients, and the research community by addressing practical drug- or device-use questions and influencing policies by converting off-label uses into guidelines or recommendations. IITs generate diverse population data, enhancing drug safety insights. However, IITs face similar operational challenges associated with clinical trial execution as industry-sponsored clinical trials but receive significantly lower budgets. Principal investigators of IITs can benefit greatly by partnering with a cost-effective protocol-to-submission solution provider centered around AI-powered unified platform technologies that automate research workflows and data management.

MANASSAS, Va., Sept. 12, 2023 /PRNewswire-PRWeb/ — Investigator-Initiated Trials (IITs) address the practical questions that arise for clinicians utilizing pharmaceuticals in their daily practices, but today, more than ever, these vitally important trials are being hindered by the high cost of the clinical trial process.

IITs are so vital because they are independently led and managed by non-pharmaceutical researchers, such as academic medical centers (AMCs), clinical researchers, public health institutions, or collaborative study groups or consortia. They focus on inquiries that go beyond Phase III trials, exploring aspects not covered in a drug development’s earlier phases.(1) Dr. Harsha Rajasimha, Founder and CEO of Jeeva Trials , is drawing attention to the need to support this essential (yet neglected) group of researchers by helping them overcome the complexities of the clinical trial process, which escalates costs and inhibits their ability to scale.

IITs vs. Industry-Sponsored Trials: Same Challenges, Different Budgets

The cost of clinical trials can range from $100,000 to well over $30 million, with significant variations based on factors such as the trial type, development phase, and focus of treatment.(2) Dr. Rajasimha explains, “The end product of an IIT is a publication, whereas, in a pharmaceutical industry-sponsored clinical trial, the end result is a marketing approval for the drug or device by the Food and Drug Administration (FDA) or the regulator. That’s the main difference. But operationally, the challenges are still the same, which means the budgets have to be the same — but they’re not. IITs have significantly lower budgets compared to industry-sponsored trials because there are potential revenue-generating sales soon after industry-sponsored clinical trials, or at least after phase III. IITs don’t have that. There is no immediate revenue benefit for IITs — with the exception of drug repurposing trials.”

The Real-World Significance of IITs

IITs are particularly valuable for exploring questions that fall outside the scope of pharmaceutical industry interests, such as off-label uses, comparing treatments from different companies, and assessing cost-effectiveness. The concept of repurposing drugs has emerged as a particularly viable approach in the quest to create treatments for rare diseases. A recent study revealed that 75% of the initiatives to develop repurposed drugs for rare conditions, approved between 2016 and 2020, were initiated through IITs within academic institutions.(3)

IITs represent the majority of all clinical trials conducted.(4) Currently, there are a total of 91,519 active studies.(5) The National Center for Biotechnology Information (NCBI) analyzed interventional clinical trials worldwide, using data from between January 01, 2015, and December 31, 2021. This allowed them to compare IITs with industry-sponsored studies based on funding type. Their analysis covered all four phases of drug development. Phase I trials were primarily industry-sponsored (over 70%). Phase II trials were evenly split between academia and industry, while Phase III trials were nearly equal (IIT: 47%, industry: 53%). Academia predominantly sponsored Phase IV trials (75%).(6)

An investigator’s role in an IIT mirrors that of other clinical trials. Their essential duties include ensuring compliance with regulations, safeguarding subjects’ rights and safety, and managing investigational product use. Specific responsibilities encompass adhering to the investigational plan, maintaining case histories, reporting progress and safety data, obtaining informed consent, overseeing drug usage, and facilitating Institutional Review Board (IRB) reviews and FDA inspections.(7)

Leveling the Playing Field With World-Class Software Solutions

IITs are beset by the prohibitive costs of clinical research, particularly broad-ranging monitoring processes that focus on irrelevant details.(4) Ongoing challenges to this invaluable research include financial constraints, regulatory hurdles, staff training, limited statistical expertise, and issues with data management and medical writing. A National Institutes of Health (NIH) study suggests establishing Clinical Trials or Research Units in decentralized academic centers that would have the necessary expertise in all aspects of the design and execution of the clinical trial. They could also involve investigators in other countries as clinical trial counterparts to engage in large-scale multicentric studies.(1) IITs can take advantage of decentralized tools such as remote video, e-consent, or capturing patient-reported outcomes data remotely through mobile-friendly apps and televisits.

IITs can benefit from the same world-class trial management software utilized by industry-sponsored trials but at affordable prices. That is why Dr. Rajasimha and his team recently launched their “protocol to publication” offering centered around the Jeeva™ eClinical Cloud, a purpose-built, unified SaaS platform with all the features and functionality to enable IIT hybrid or decentralized clinical trials under one login from any browser-enabled mobile device. Jeeva’s team assists academic investigator-initiated trials with study design and protocol writing, offering expert guidance and support, seamless eClinical solutions, enhanced study configuration, data management, biostatistics, and manuscript preparation.

Dr. Rajasimha attests, “Jeeva is proud to offer an affordable and comprehensive solution for academic principal investigators, supporting them from the initial protocol preparation phase to publication. Our end-to-end turnkey solution ensures a smooth and efficient workflow for investigator-initiated trials, assisting academic researchers conducting both interventional and observational cohort studies.

To learn more about Jeeva’s cost-effective solution for IITs, visit our website

About Jeeva Clinical Trials Inc.

The personal experience of losing a child born with a rare congenital disorder and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral research experience at the NIH and FDA to accelerate therapies for rare and common conditions. He founded Jeeva with the mission of lowering the cost of drug development and accelerating the speed of clinical trials by purpose-building a modern technology platform that empowers sponsors to run clinical trials, with fewer fragmented systems, fewer employees, with significantly less burden on clinical researchers and patients, which has allowed for a more globally diverse population to access clinical trials remotely.

Today the Jeeva eClinical Trial platform supports sponsors and CROs across the globe helping reduce the logistical burdens on patients and study teams by over 70%. Its complete suite of technology supports fully decentralized and hybrid clinical trials and has resulted in being selected by research hospitals, CROs, and sponsors developing pioneering therapeutics such as Frantz Viral Therapeutics and ImmunoACT. The Virginia-based company’s modular cloud-resident software-as-a-service is highly scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials from one login from any browser-enabled mobile device. Visit


1. Konwar, Mahanjit, et al. “Investigator-Initiated Studies: Challenges and Solutions.” Perspectives in Clinical Research, U.S. National Library of Medicine, 2018,
2. V. “What Should Be Included in a Clinical Trial Budget for 2022.” Mosio, 10 June 2022,
3. Aacute;lamo, Marta del, et al. “Identifying Obstacles Hindering the Conduct of Academic-Sponsored Trials for Drug Repurposing on Rare-Diseases: An Analysis of Six Use Cases – Trials.” BioMed Central, BioMed Central, 15 Sept. 2022,
4. Buyse, Marc, et al. “Central Statistical Monitoring of Investigator-Led Clinical Trials in Oncology.” International Journal of Clinical Oncology, U.S. National Library of Medicine, July 2020,
5. CTG Labs – NCBI, Accessed 7 Sept. 2023.
6. Hoffmann, Jean-Marc, et al. “Academic Clinical Trials: Publication of Study Results on an International Registry-We Can Do Better!” Frontiers in Medicine, U.S. National Library of Medicine, 24 Nov. 2022,
7. Meghan Hosely, Marketing Copywriter. “Beginner’s Guide to Investigator-Initiated Trials.” Advarra, 31 Oct. 2022,

Source: PRWeb