Four Keys to Successfully Supporting Ophthalmology Clinical Trials

Preparing for an upcoming ophthalmology clinical trial? Explore four critical pieces of advice from our expert team.

1. Putting Yourself into the Patient’s Shoes

As you plan your ophthalmology clinical trial, it’s essential to place yourself into your patients’ shoes and consider their journey and potential challenges.

A 2019 article in the Osteopathic Family Physician noted that 2-3% of primary care office visits are eye-related complaints. Conditions commonly seen by PCPs include conjunctivitis, strabismus, uveitis, entropion, ectropion, pterygium, stye, and chalazion. (Kaur et al., 2019)

If your ophthalmology study includes pediatric populations, the consent process must be especially clear, with procedures in place for any possible situations that may arise. For example, what happens if the patient’s parents separate or divorce during the study? What happens if guardianship changes?

2. The Importance of an Excellent Medical Monitor

Medical monitors are always essential assets to a study team, as they have an intimate knowledge of study protocol and robust clinical and academic experience as physicians. A specialized medical monitor with experience in ophthalmology is especially important for these clinical trials.

3. Qualifying Site Staff

It’s important to look closely at the qualification of treatment administrators and staff members. For example, if retina injections are required for your ophthalmology study, a qualification process may need to be created to distinguish between qualified staff (whether they are retina specialists or non-retina specialists) and unqualified staff who may not perform injections in the study. Similarly, if your study includes imaging, it’s critical to qualify each site’s technicians to confirm that images are comparable.

4. Limitations During Site Selection

Unlike many clinical trials in non-ophthalmology indications, equipment for ophthalmology is typically not supplied due to cost limitations. This adds an additional layer of assessment as sites are evaluated.

During the feasibility process, exam rooms must be qualified to see what equipment is available at each site. Sponsors may opt to work with large vendors to encompass the standard equipment used across all sites.

Exploring Standard CRO Timeline Benchmarks

Preparing to work with a top biometrics contract research organization and wondering how their promised data management, biostatistics, and medical writing timelines match up to the industry average? To help sponsors dig into these details and ensure the timelines they’re receiving are competitive, we’re providing PharPoint’s typical timelines alongside research that calculates industry standard timelines, when available.

Our hope is that this document can help sponsors set realistic expectations, confidently ask the right questions of their vendors, and ultimately, partner with a top biometrics CRO that keeps their study moving: because patients are waiting.

eBook contents include:

PharPoint’s short eBook, Standard Clinical Trial Timelines: A Sponsor’s Guide to Evaluating Biometrics CROs, includes the below information.

• Standard database build timeline
  • The bigger picture: Considering site identification and study start-up
• Standard mid-study database change timeline
• Standard database lock time
  • Six strategies for a faster database lock
• Evaluating database lock to top line results timeline
  • Ensuring a rapid delivery
• Evaluating database lock to delivery of tables, listings, and figures (TLF) timeline
• Standard clinical study report delivery timeline
• About PharPoint Research