Designing therapies that change the status quo is a complex balancing act. Clinical trials are at the heart of this endeavor, a gateway between the ever-accelerating pace of basic research and thoroughly vetted therapeutic strategies that have a positive impact on patients.
In many ways, clinical trials are the real-world application of the paradigm-shifting discoveries made in the lab. They are an absolutely vital — and required — component of transforming a basic finding into a usable and effective therapy that changes the standard of care for diseases such as cancer, Parkinson’s and other devastating conditions. Rigorously designed, conducted and regulated, these trials tell us if a particular drug is safe, if it is effective and if it has side effects. Importantly, clinical trials also help fine-tune the drug regimen, ensuring that recommended doses are appropriate, in addition to other guidelines.
At the same time, clinical trials also present some obstacles. Currently, it is estimated to take roughly a decade and more than $2 billion to move a new drug from the lab to the clinic, a cost that can stymie or delay much-needed treatments. These challenges are augmented by the time and capital required to make the initial discovery and conduct the massive amount of required testing before beginning a clinical trial.
Given the facts, it is absolutely imperative that we find new and innovative ways to improve and streamline the process in order to get novel, effective and safe therapies to patients in a timely manner.
Put simply: People with these devastating diseases don’t have time to wait, and neither do we.
Numerous efforts are underway nationally and locally to make this process more efficient while also maintaining its integrity and critical safeguards. It’s a delicate balance. Trials must be efficient, but they must also be effective.
One way we are working to accomplish this is through strong collaborations among scientists, clinicians, patients, industry and philanthropy. The Van Andel Research Institute-Stand Up To Cancer Epigenetics Dream Team brings together these stakeholders to compete against cancer rather than against each other.
The first trial conducted under the auspices of the team is now enrolling patients at Johns Hopkins University, Memorial Sloan Kettering Cancer Center, University of Southern California and at VU University Medical Center in the Netherlands to evaluate a promising new drug combination for metastatic colorectal cancer. It is, we hope, the first of many.
This particular trial is representative of a growing trend: combination therapies that tackle cancer on multiple fronts rather than with a single, one-size-fits-all drug. In the current colorectal cancer trial, a novel agent has been paired with a standard chemotherapy drug. Early results have demonstrated that this has made resistant tumors more likely to respond to traditional treatments.
Developing these therapies usually is the result of a different kind of innovative combination, one that merges expertise from the best scientific minds in research and in medicine with intricate insights into drug development and drug mechanisms from industry partners, all backed by a strong infrastructure and a collaborative spirit.
Reducing the time and cost required to bring a new therapy to the clinic is crucial to enhancing the trial process.
Many medications already in the marketplace that have passed crucial safety and efficacy trials for treating a particular disease also show promise in lab experiments as potential therapies for other conditions. Called drug repurposing, this approach offers an innovative avenue for finding the therapies of tomorrow while saving precious time and resources.
It is exemplified by the Linked Clinical Trials initiative, a collaboration between the Institute and The Cure Parkinson’s Trust, which repurposes drugs that have shown favorable lab results for treating Parkinson’s disease. In addition to LCT, a team of VARI and Michigan State University scientists is investigating a cardiovascular drug’s potential to protect neurons and reduce inflammation associated with Parkinson’s disease. Their team is working to move this promising therapy into a clinical trial.
These endeavors illustrate that optimizing the clinical trial process through streamlining, collaboration and creative thinking can — and should — be done.
In recent years, we have crystallized our commitment to moving new and more effective therapeutic strategies into clinical trials through our collaborators in Grand Rapids and across the U.S. and abroad.
As members of the city’s thriving health and biomedical research community, we have a unique opportunity to leverage innovative thinking and orchestrate more effective clinical trials, in order to provide new therapies to the people who need them most: the patients.
David Van Andel is chairman and CEO of Van Andel Institute.