Five Critical Qualities for Identifying a Partner to Globally Scale Ophthalmology Clinical Trials

Commentary
Article

Amplifying the size and diversity of participant pools in clinical trials enhances statistical power and increases the generalizability of study findings.

Image credit: ryanking999 | stock.adobe.com

Image credit: ryanking999 | stock.adobe.com

Biopharmaceutical companies developing vision-improving therapeutics are increasingly focused on drugs to target rare eye diseases. As a result, it is more essential than ever to expand the global reach of ophthalmic clinical trials. But finding the right partner to help you scale can seem like a daunting challenge.

Which capabilities are the most important to consider? How do you strike the right balance in the cost-benefit analysis? Is it even possible to find a partner who can adapt and expand their support alongside you and your study?

Reasons to expand the global reach of ophthalmic clinical trials

Let’s start at the beginning and explore why expanding the global reach of ophthalmic clinical trials is so beneficial. The most compelling—and obvious—reason is that amplifying the size and diversity of participant pools enhances statistical power and increases the generalizability of study findings.

That’s because including participants from a broad range of geographical areas helps capture different genetic backgrounds, lifestyles, and environmental factors, which then increases the likelihood that study findings are more representative and applicable. This is particularly important for rare diseases or conditions for which enrolling an adequate number of study participants may be challenging.

Other reasons to expand the global reach of ophthalmic clinical trials may be somewhat more obscure, but they are still consequential. For example, conducting trials in multiple countries requires researchers to navigate diverse regulatory environments and approval processes, which can expedite market access and commercialization down the road. There could also be cost efficiencies in certain countries or regions, due to factors such as lower labor costs, reduced administrative expenses, or more favorable economic conditions.

Five critical qualities of the right ophthalmic clinical trial partner

Understanding why you need to expand the global reach of your ophthalmic clinical trials is the first step. Next, you’ll need a clinical partner to operationalize and support your efforts. As you evaluate various clinical partners, keep these five critical attributes top of mind:

1. Knowledge and expertise supporting clinical trials and ensuring patient safety

The partner you choose must offer expert support throughout the trial lifecycle, beginning with the training and qualification of sites and readers, and then moving on to clinical project and data management, image QC and analysis, and finally, regulatory submission. Your partner should have deep clinical expertise—and not only in ophthalmology, but also in other therapeutic areas, indications, and modalities.

Why is cross-therapeutic area study experience important? Because adaptability and problem-solving prowess are indispensable for mitigating risks, addressing unforeseen issues, and optimizing trial processes to ultimately deliver reliable and impactful results. In clinical research, how your partner adapts and responds to adversity is as important as their ability to anticipate risk.

2. Capacity for global reach

Beyond having knowledge and cross-therapeutic clinical expertise, the partner you choose must have proven capabilities for international work in the field of ophthalmology. After all, to identify and select appropriate research sites in different countries, you and your partner will have to evaluate factors such as the prevalence of the target eye condition, regulatory environments, and the availability of investigators and site staff who specialize in ophthalmology.

In addition, there may be challenges related to a wider range of image acquisition scanner makes, models, ages, and software that vary widely from country to country. You’ll also need to obtain approval from local ethics committees or Institutional Review Boards (IRBs) so that the trial protocol aligns with the specific regulations and ethical standards of each region.

Additionally, your team will need to consider cultural and linguistic differences to ensure effective communication across all aspects of protocol design, site management, and patient support. Finally, you should ask your potential partner if they offer 24/7/365 global multi-lingual technical support for clinical trial study sites.

3. Advanced technology, including artificial intelligence (AI)

Advanced quantitative image analysis is now an essential part of ophthalmology trials. To expand your global reach, look for a clinical trial partner that uses artificial intelligence (AI) to not only expedite image analysis and streamline workflows, but also to facilitate remote patient monitoring, promoting accessibility, and real-time data collection.

For example, today’s most sophisticated AI technology can accurately identify and segment retinal tissue layers to improve image reader accuracy and data quality. Further, your ophthalmic clinical trial partner’s AI should be able to rapidly assess optical coherence tomography (OCT) and fluorescein angiography (FA) image quality and immediately notify sites if a rescan is required. You’ll also want a cloud-based image and data management platform that is 21 CFR Part 11 and GDPR compliant, has a contiguous audit trail, and comes with 24/7 global IT support and deployment.

4. End-to-end continuity and integration

Optimally, your clinical partner can provide fully customizable, proprietary quantitative image analysis incorporated within a completely configurable, study-specific workflow. You’ll want a consolidated closed-loop imaging management system that works end-to-end from site upload, image quality control, and read to data cleaning and delivery—all without cobbling together third-party vendors and software.

This level of continuity helps ensure there are no breaks in your study audit trail and that you have complete transparency and visibility across all processes. Without it, your study is at increased risk for data inconsistencies, quality headaches, and regulatory non-compliance.

5. Trust

You must be able to rely on your clinical trial partner to adhere to rigorous protocols, prioritize participant safety, and uphold regulatory standards. A trustworthy partner instills confidence in the trial process and ensures the responsible handling of sensitive data, maintaining confidentiality, and compliance. Whichever partner you choose, expanding the global reach of your clinical trial is a collaborative endeavor, and mutual trust cultivates open dialogue, support, and innovation—all of which are foundational to study success.

Moving forward with global, AI-driven ophthalmology clinical trials

The development of new ophthalmic therapeutics increasingly requires global, AI-enabled clinical trials. Although these trials will undoubtedly lead to improvements in eye health, they also pose significant challenges for their sponsors.

That’s why choosing the right clinical trial partner is so critical. Your partner must have the knowledge, expertise, and capabilities to expand your reach internationally and deploy the right combination of traditional and AI technologies efficiently and effectively. Your partner should also have the necessary experience to help you plan for the global success of your new drug by supporting your clinical trial journey from Phase I all the way through Phase III and beyond.

Ultimately, the right ophthalmic clinical trial partner will enable your research team to focus on the nuanced aspects of your ophthalmic drug development program, enhancing the overall success of your trial even more.

About the Authors

Amit Vasanji, PhD, is Vice President of Medical & Scientific Affairs at Clario, a leading healthcare research and technology company that generates clinical evidence for pharmaceutical, biotech and medical device partners.

Brett A. Hoover is Global Management Team Site Lead (CLE) and Director of Global Project Management for Medical Imaging at Clario.

Related Videos
© 2024 MJH Life Sciences

All rights reserved.