Clinical Trials are Expensive

We are no doubt in an exciting time as more clinical trials of promising treatments come to fruition. But as we have been reporting in recent years, clinical research brings a whole new financial challenge to the Foundation and our supporters. Human studies cost several million dollars each and are many times more expensive than laboratory studies.

We feel it is important for you — our donors and volunteers who are working so hard to support our mission — to understand why human studies are costly. So we’d like to provide you with an overview of the services and resources that drive clinical trial costs. 

First and foremost, clinical trials are labor intensive, requiring the time and effort of many highly trained medical and technical professionals. Clinical tests and exams of trial participants often consume many hours. A clinical evaluation can last an entire day with physicians, ophthalmic assistants and technicians, and testing experts all taking part in the process.

A trial participant may be evaluated six or more times a year, and may be in the study for as long as three years. When you consider that each participant visit can cost thousands of dollars — and hundreds of participants may go through the clinical trial process — it isn’t surprising that expenses add up quickly. And these costs are often not covered by insurance. 

A large portion of clinical trial expenses also comes from complying with FDA regulatory requirements. The agency protects the American public by regulating the planning and conduct of clinical research. The FDA also ensures there is substantial evidence that the benefits of the treatment or intervention far outweigh the risks.

The FDA mandates that the participant data gathered throughout the trial is thoroughly monitored for accuracy — a process that requires extensive resources. In addition, any serious adverse events must be reported in an expedited manner. Ultimately, all data must be analyzed and reported to the FDA.

While the FDA is recognized as one of the world’s leaders in regulating clinical trials and medical treatments, there is a global effort to harmonize regulatory practices to ensure that clinical trial participants are strongly protected, regardless of the study location. In the short term, as the Foundation expands its clinical trial initiatives globally, we need to meet the regulatory requirements of other countries, which will inevitably increase our development costs.

Companies and organizations conducting clinical trials often obtain the services of a clinical research organization (CRO) to help with various study processes and compliance with the FDA’s extensive regulations and documentation requirements. CROs provide services such as data collection and management, statistical analyses, and medical writing and reporting. CROs also maintain the latest in information processing technology to store and manage the huge amounts of data generated from each study.

And finally, in addition to the cost of people and technology, a company also incurs the expense of producing the drug or treatment being studied. The FDA mandates that companies follow current good manufacturing practices in the production of the therapy. These procedures are stringent to ensure safety and quality, and include guidelines for storage and distribution of the drug or therapy. While the Foundation does everything it can to manage the costs of clinical research, there aren’t any shortcuts when it comes to conducting a clinical trial. Good science — whether it is in the lab or the clinic — doesn’t come cheaply. But good science is what delivers vision-saving treatments and cures, and we at the Foundation are committed to funding the world’s best and most promising retinal research.