It’s no secret pharmaceutical companies face a long, uphill battle to bring new drugs to market. And one of the biggest challenges is finding and engaging the right clinical trial participants.
In fact, almost half of all clinical trials are delayed because of patient enrollment issues. And a staggering 94% of trials aren’t completed on time.
Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), knows as well as anyone the roadblocks involved in drug development. “If a pharmaceutical company can’t recruit enough participants and follow them through to completion of the trial,” Kremedis said, “the product can’t be fully tested, approved by the FDA and go to market.”
At Javara, that’s why we built our integrated research organization (IRO) model to transform the clinical trial process for everyone involved. And in order for it to work for pharmaceutical companies, we knew it had to address this core challenge of improving clinical trial participation.
“If a pharmaceutical company can’t recruit enough participants and follow them through to completion of the trial – the product can’t be fully tested, approved by the FDA and go to market.”
Jim Kremidas, ACRP
Pharmaceutical Clinical Trial Trends: Expanding Access to Participants
Traditionally, clinical research has been siloed from the rest of healthcare and patient treatment, making it hard to identify the right patients for clinical trials. The Integrated Research Organization (IRO) model fixes this right from the start by embedding an innovative clinical trials infrastructure within health systems – providing access to select trials that meet the specific needs of the system’s patient population.
In other words, pharmaceutical companies are no longer limited by the reach of an investigator and the providers they know. Instead, they can cast a wide net and find patients that fit a trial’s profile when health systems commit to offering clinical trials as a care option.
However the big win is not only access to a bigger pool of patients, but access and partnership with a healthcare system. Since the IRO is integrated into the whole health system, it increases awareness of ongoing trials among the system’s physicians and providers. They can more confidently educate and advocate patients to consider clinical trial participation as an option for care, knowing the IRO will handle the heavy lifting of taking care of the patient volunteer needs, impeccable data collection requirements all while efficiently managing the overall conduct of the trial.
Reaching the Finish Line
Finding and enrolling the right patients is a huge step, but it’s not the end goal. Many clinical trials see significant loss to follow-up rates as patients drop out of the trial before completing it.
Again, this roadblock is inherent in the current clinical trial system: Many patients are sent to a separate site to manage their clinical trial, and there may be a lack of continuity in care with their provider. The IRO model reduces loss to follow-up rates by being fully embedded in the health system. Patients’ overall trial experiences are managed on site, and they receive a consistent, comprehensive care experience as the IRO works seamlessly with their providers.
If a patient misses an appointment or show signs of non-adherence to their trial, the IRO is embedded and onsite so they can easily follow up to keep the patient volunteer from slipping through the cracks. As a result, patients stay engaged in the trial and are more likely to follow it to completion.
Many clinical trials see significant loss to follow-up rates as patients drop out of the trial before completion. The IRO model addresses this by being fully embedded in the health system to follow patients through the process.
Shorter Trials Lead to Better ROI
When you combine a bigger patient pool and a larger network of referring physicians with lower loss to follow-up rates, you see an exponential impact as clinical trial timelines shrink.
But the benefit doesn’t end there.
By partnering with an experienced IRO that understands clinical research inside and out, you can come away with larger, more dependable data sets, which can help with FDA and compliance approvals and influence clinical decisions. New drugs are able to reach the market faster and faster.
And once a drug is approved, marketing is easier because you already have relationships with a large pool of physicians who were involved in the trial and have seen the benefit to their patients first-hand.
At each one of these steps, the IRO removes roadblocks and improves efficiency, simultaneously increasing your ROI and introducing invaluable treatment options for people around the world.
IROs and You
Want to learn more about how Javara’s Integrated Research Organization (IRO) model can impact drug development? Contact us today.
To learn more about the power of our IRO model, read how it also benefits hospital systems and improves the patient care experience.