Translational research needs a different model.
Translational research involves human subject trials to determine the safety and efficacy of a biomedical or health technology. The results can make or break a technology, product, or company. Designing, executing, and reporting the results of clinical trials is a key step in the life science innovation roadmap and is one of the most expensive and risky parts of drug, device and digital health development.
Drug and device companies and biomedical and health entrepreneurs are searching for ways to make clinical trials better, faster, and cheaper and more accessible for patients who want to enroll in them. For example, only 3% of adult cancer patients enroll in clinical trials and there are many reasons why. While the challenges are big, so are the opportunities. Here are some trends:
1. Outsourcing the nuts and bolts of clinical trials to clinical research organizations.
2. Partnering with global medical travel sites to enroll patients from around the world.
3. Using electronic medical records to improve data access, analysis and reporting.
4. Creating integrated data repositories to break down the silos that presently exist across the continuum of care.
5. Creating digital health eCROs to demonstrate the safety and efficacy of not just drugs and devices, but digital health products, like remote sensors, apps and wearables as well.
6. Building mobile apps and programs to decentralize enrollment and execution of trials at the point of care.
7. New clinical trial business models, allowing private practitioners or any other provider to be part of a community-based clinical trial network with minimal work flow disruption and a potential opportunity to generate additional revenue.
8. Breaking down the barriers between entrepreneurs, principal investigators, and the guardians of patient data at hospitals.
9. Creating educational and training programs for those interested in a career in clinical trial execution.
10. Mandates that require reporting not just the good, but the bad and the ugly as well, along with conflict of interest disclosures.
Scientists, engineers, computer scientists, and health professionals aren't interested in clinical trials because: 1) They don't have the knowledge, skills, or abilities to participate in clinical trials. 2) They don't have enough incentives to participate. 3) They are already time constrained and don't see the value. 4) They think the costs of participating outweigh the benefits. 5) They don't want to assume the risk and deal with even more administrivia.
One big biomedical and health innovation bottleneck is our ability to demonstrate that something works in patients in a way that won't break the bank. Like almost every other innovation, that will require new rules, ecosystems, and business models that will allow clinical trial innovation to see the light of day.