Access to Patients - The Hardest Part of Clinical Research
When people think about clinical research, they often imagine the science, the technology, the cutting-edge molecules being tested. Very few think about the most basic challenge: how do we find the right patients to participate in the study?
It sounds straightforward, but it’s not. Patient access is often the number one bottleneck in drug development. Without patients, there is no study. Without studies, there is no data. And without data, there is no new treatment.
Why Access Is So Complicated
Every clinical trial is designed around a protocol. These protocols are extremely detailed, with strict inclusion and exclusion criteria. We need this precision, because to measure safety and efficacy, you must study the right patient population.
But the stricter the criteria, the smaller the pool of eligible patients becomes. That means if we want to recruit 100 patients, we may need access to several thousand. In oncology, for example, sometimes we screen ten patients to find one who qualifies.
This is why timelines so often break. It’s not that the science doesn’t work. It’s that we can’t bring the right patients through the door fast enough.
The Traditional Sources
Over the last two decades, I’ve seen what works and what doesn’t. Patient access comes down to three main sources:
Your own patient database
This is gold. When you’ve built a large database over time, you can respond quickly to new trials. You don’t need to start from zero with every project. A strong database gives you predictability and speed.Referral networks
No single center can do everything alone. That’s why partnerships with general practitioners, specialists, and referral hospitals are so powerful. When networks are strong, they become an extension of your own patient pool.Direct-to-patient outreach
This has changed the landscape. Social media, digital platforms, and patient communities allow us to connect directly with people who want to participate in research. Regulations still limit advertising in many countries, but this channel is growing, and it reflects a broader trend: patients are more informed and proactive than ever before.
More Than an Operational Challenge
For me, recruitment has never been just an operational task. It goes to the heart of why we do this work.
I remember one of our oncology patients very clearly. She came to us with late-stage cancer and was given only a few months to live. Through a clinical trial, she received an investigational therapy that went on to become one of the world’s leading cancer drugs. Instead of a few months, she lived more than seven years.
Seven years is not just more time, it’s birthdays, graduations, holidays, and moments her family would never have had without access to that trial.
Stories like this remind me every day that access is not about filling a spreadsheet or meeting a recruitment target. It is about giving people the chance to benefit from innovation years before it reaches the market.
The Way Forward
So how do we improve? There is no single answer. The reality is:
Databases must be built continuously. You can’t start building them the day a trial begins.
Referral networks require trust. Doctors need to know that when they refer a patient, that patient will be treated with the highest care.
Direct-to-patient outreach must be done ethically. Patients need transparency, support, and respect.
At CRU, we use all three. That is why we can deliver faster timelines and higher-quality data. But even more importantly, that is why patients and families trust us.
Why This Matters
Every delay in recruitment means a delay in bringing new therapies to patients who desperately need them. And in medicine, time is everything.
Access to patients is not just a challenge of logistics, it is a challenge of responsibility. If we solve it, we don’t just run faster trials. We bring hope to people earlier. We give them more time. And sometimes, as I’ve seen firsthand, we give them a second chance at life.
That is the real reason patient access matters.
Peter M. Kovacs
References
Desai T, et al. (2020). Recruitment and Retention of Participants in Clinical Studies.
More than 80% of clinical trials fail to enroll on schedule.
https://pmc.ncbi.nlm.nih.gov/articles/PMC7342339/Laaksonen R, et al. (2022). Success and Failure Factors of Patient Recruitment for Industry-sponsored Clinical Trials in the Nordic Countries.
Only about one third of trials recruited as planned.
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06144-9Shadbolt NL, et al. (2023). Rates of Completion, Delays, and Participant Recruitment Shortfalls Among Surgical Trials.
Only 14.6% of trials were completed on time and with full enrollment.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800488Briel M, et al. (2021). Exploring Reasons for Recruitment Failure in Clinical Trials.
Recruitment failure is the most frequent reason RCTs stop early.
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05818-0CancerNetwork (2021). Overcoming Obstacles to Clinical Trial Recruitment and Retention.
Up to 20% of clinical trials fail due to insufficient enrollment.
https://www.cancernetwork.com/view/overcoming-obstacles-to-clinical-trial-recruitment-and-retention