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Investigator-Initiated Studies, IIS: An Opportunity for Research Sites

Investigator-Initiated Studies-IIS

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Investigator-Initiated Studies (IIS) are studies where an individual investigator, a research site, or a group of research sites carry out the research from the protocol design until regulatory submission. This means they perform both roles, as a sponsor and as an investigator. 

This type of clinical research also has been known as investigator-initiated trials, independent studies, investigator-sponsored Studies, and investigator-initiated research, among others. It demands demonstrating high-performance capabilities while carrying extensive responsibilities, like proper staff selection, enrollment, financial disclosures, monitoring, control, reports, and documentation. 

According to Mahanjit Konwar, from the Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital in Mumbai, the benefits of conducting Investigator-Initiated Studies (1) are:

  • Data are generated in the real-world setting
  • Applicable to the population where the study is conducted
  • Assist in developing hospital/state/nation-specific policies
  • Learning tool for site staff to enhance their research skills and helps in team building
  • Helps in the repurposing of licensed drugs and can convert off-label use into a guideline or policy recommendation.
  • Generates more safety data and aids in benefit-risk assessment, mainly if pragmatic trials are conducted as IISs.
  • Greater generalizability as the studies are conducted in real-world conditions, unlike regulatory studies, which are conducted in relatively homogenous populations.
  • Fewer commercial conflicts of interest 
  • Answer research questions that plague physicians in their day-to-day practice.

Investigator Initiated Studies (IISs) in low and middle-income countries (LMIC) would help to generate local evidence, which may be more likely to influence health policies and practices rapidly (3); due to this, trials tend to be more clinical practice driven. Additionally, to the benefit of engaging local communities, the experts outstand that low and middle-income countries could take advantage of IISs by taking more responsibility for their research activities, building capacity, and developing sites to run international trials.

According to Viraj Suvarna, Medical Director of Boehringer Ingelheim India, what is driving the need for IISs is that clinical trials are not, and cannot be, designed to determine all the potential uses of a medication (4). Consequently, the proper conduction of IISs expands the knowledge, safety, and data, which can be used to improve patients’ access to better treatment, vaccines, drugs, or devices.

Fuente: Producido por EC and OECD basado en la clasificación del Banco Mundial

When the investigator assumes full responsibility for the study, this impacts the budget as the investigator performs all the tasks; does operative costs management, and has flexibility regarding the trial design. However, this also represents some challenges for the investigator or site, like ensuring compliance and non-scientific and administration burden. Also, some IITs (Investigator-Initiated Trials) have experienced challenges associated with initial trial implementation and database management (2).

Technology as an enabler of Investigator-Initiated Studies IIS

Developing IIS with the help of technology in low and middle-income countries can substantially benefit the local science and research field and drug access. Studies by Kansas University Cancer Center (5) have shown the positive impact of systematically using informatics tools like e-CRF and CTMS along with process standardization in IISs. Monitoring tools helped to achieve more innovative study designs and faster and more efficient trials. As well as collect more rigorous data to provide evidence supporting the stated hypotheses. See the graph below:

Investigator Iniciated Studies
Fig. 2. IIS realizados en el KU Cancer Center entre 2012 y 2018.

Investigators or research sites in LMIC tend to have additional barriers related to capacity, safety, budget management, and regulatory risks. They can overcome these challenges with robust internal policies, adherence to regulatory requirements, resource optimization, and technology as the great enabler.

Integra IT experience in supporting IISs in emerging markets has shown a group of limitations regarding the proper performance of IISs, but has also encountered through technology, the precise way to overcome them:

Risk

Mitigation through technology

Non-compliance with regulations

  • Use validated systems (GCP, FDA’s 21 CFR Part 11, HIPAA)
  • Compliance with data protection and security standards through CSV (Computer System Validations). 

Increase times due to paper use and traditional operations practices

  • Minimize manual processes with an all-in-one software platform.
  • Use electronic signature
  • Fill out electronic reports like visits

Dependence on sponsors and CROs systems

  • Invest and choose a site software system that adapts to the site necessities. 
  • Increase multi-study capabilities.
  • Run different types of trials (decentralized, hybrid, remote). 

Overcapacity, align the business strategy and budget

  • Use digital tools that make efficient the critical stages like; enrollment, monitoring, and laboratory.
  • Start with a scalable/modular solution in order to begin the transition with less impact. 
  • Use performance metrics to fix capacity issues.

Poor technology knowledge and literacy 

  • Increase staff expertise and technology literacy with local training, support, and change management.
  • Use technology in the site’s local language. 

Delays in milestones, deliverables, and reports

  • Run faster recruiting, enrollment, engagement, and retention with the tracking features of digital tools. 
  • Access to real-time data and get early evidence with web-based data management services.

Surpassing these challenges can make LMICs research sites more competitive, attracting research and innovation investment. With software solutions, they can broaden organizational capabilities and support the scientific performance of investigators, for example, with data management services and electronic data capture (EDC).

Additionally, according to Julio Martinez-Clark, CEO of Bioaccess (6), regions like Latin America have taken advantage of the recruitment crisis in the U.S and its high healthcare costs by having a reduced cost model, easier and faster subject recruitment and faster regulatory approvals. Therefore, foreign investment has increased in Latin America to run clinical trials.

Integra IT Solutions for Sites

To address common barriers when running an IIS, Integra IT has developed an accessible software solution for research sites. The solution’s core is Trial 360, the best cost-benefit ERP (Enterprise Resource Planning) in the industry, tailored-made to address the challenges IIS brings to sites, including emerging market challenges, especially in Latin America, where vaccine clinical trials are growing.

Trial 360 is designed so sites can conduct end-to-end clinical trials seamlessly, allowing them to perform from the recruiting and enrollment processes to the scheduling, visit management, including a validated EMR (Electronic Medical Record) and lab samples management system. 

The Integra IT solutions include TrialPal App (eCOA and ePRO) to collect data directly from the patients. This TrialPal App integrates with Integra IT EDC/eCRF component reducing manual data entry efforts and errors while making data management easier and faster.

Integra IT solutions ecosystem makes site operations efficient under high-quality standards; systems validated following the International Conference on Harmonization (ICH)-Good Clinical Practices (GCP), and FDA 21 CFR Part 11.

Integra IT solutions ecosystem makes site operations efficient under high-quality standards; systems validated following the International Conference on Harmonization (ICH)-Good Clinical Practices (GCP), and FDA 21 CFR Part 11.

Learn more about Integra IT’s dedicated solutions for research sites here:

References:

  1. Konwar M, Bose D, Gogtay NJ, Thatte UM. Investigator-initiated studies: Challenges and solutions. Perspect Clin Res. 2018 Oct-Dec;9(4):179-183. doi: 10.4103/picr.PICR_106_18. PMID: 30319949; PMCID: PMC6176691. [Cited: September 19, 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6176691/#:~:text=What%20are%20investigator%2Dinitiated%20studies,group%20or%20a%20cooperative%20group 
  2. Vermeersch K, Demeyere B, Denaux K, De Nys K, Troosters T, Brusselle G, Janssens W.Challenges and threats of investigator-initiated multicenter randomized controlled trials: the BACE trial experience. 10-19-2019. [Cited: September 19, 2022] https://www.ijclinicaltrials.com/index.php/ijct/article/view/350 
  3. Franzen SR, Chandler C, Enquselassie F, Siribaddana S, Atashili J, Angus B, Lang T. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia. BMJ Open. 2013 Nov 27;3(11):e003616. doi: 10.1136/bmjopen-2013-003616. PMID: 24285629; PMCID: PMC3845054. [Cited: September 19, 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3845054/
  4. Suvarna V. Investigator-initiated trials (IITs). Perspect Clin Res. 2012 Oct;3(4):119-21. doi: 10.4103/2229-3485.103591. PMID: 23293757; PMCID: PMC3530977.[Cited: September 21, 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3530977/
  5. Mudaranthakam D, Phadnis M, Krebill R, Clark L, Wick J, Thompson J, Keighley J, Gajewski BJ, Koestler DC, Mayo MS. Improving the efficiency of clinical trials by standardizing processes for Investigator Initiated Trials, Contemporary Clinical Trials Communications, Volume 18, 2020. 100579. ISSN 2451-8654. [Cited: September 21, 2022] https://www.sciencedirect.com/science/article/pii/S2451865420300636?via%3Dihub 
  6. Martinez JG. Latin America: A Compelling Region To Conduct Your Clinical Trials. Guest Column. Clinical Leader. 2022. [Cited: September 28, 2022] https://www.clinicalleader.com/doc/latin-america-a-compelling-region-to-conduct-your-clinical-trials-0001

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