The clinical trial system for biopharma and medtech has several flaws, and, for digital health, is virtually non-existent.
Testing your product in humans to demonstrate its safety and effectiveness is a critical step in getting regulatory approval, investor interest, and customer-patients. The clinical trial system for biopharma and medtech, however, has several flaws, and, for digital health, is virtually non-existent.
Those of us who have sat on dysfunctional Institutional Review Boards (IRBs) on either side of the table, participated in trials, or have had to deal with the administrative, clinical, and regulatory hassles, feel the pain.
A recent summary of a workshop designed to recommend solutions to the barriers highlighted the fact that "cooperation among a diverse group of stakeholders—including research sponsors (industry, academia, government, nonprofit organizations, and patient advocates), clinical investigators, patients, payers, physicians, and regulators—is necessary in conducting a clinical trial today. Each stakeholder offers a different set of tools to support the essential components of a clinical trial."
The working group identified the following main challenges:
1. Prioritization of clinical research questions
2. The divide between clinical research and clinical practice
3. Globalization of clinical trials
4. The cost of clinical trials
5. Narrow incentives for physician participation in clinical trials
6. The shrinking clinical research workforce
7. The need to navigate administrative and regulatory requirements
8. Recruitment and retention of patients
Not mentioned were:
9. The lack of a digital health trials ecosystem
10. How to find money to conduct clinical trials
Of note is that one of the participants in the group, Dr. Robert Califf, formerly at Duke doing cardiovascular clinical trials, is now the Commissioner of the Food and Drug Administration.
As noted, “the poor rate of adoption of effective clinical practices is reflected in one study that examined adherence to 439 indicators of healthcare quality for 30 acute and chronic conditions and preventive care.
Results indicated that American adults receive on average only 54.9% percent of recommended care.”
Another result is that few of the 165,000 mobile medical apps are clinically valid.
So, other than lobbying for federal regulatory and administrative reform, what can bioentrepreneurs do locally to facilitate clinical trials?
1. Contact the closest Translational Science Institute or the National Institutes of Health for information and guidance.
2. Include courses in clinical trials in the curriculum of bioentrepreneurship education programs
3. Build a digital health ecosystem that includes an eCRO (electronic clinical research organization) to streamline digital health trials
4. Build better bridges between the stakeholders
5. Find a better way to fund clinical trials, given their exceedingly high-risk nature
6. Educate and inform clinical investigators about executing clinical trials outside of the US and the issues concerning using the data to get FDA approval
7. Address the issues concerning conducting clinical trials on the medicinal use of marijuana at the state and federal level
8. Make patient and physician participation in clinical trials a public health priority
9. Streamline the IRB process, particularly for digital health trials
10. Break down academic-industry-community translational research barriers
Funding, designing, executing, analyzing, and deploying the results of trials in patients is a critical success factor for almost every biomedical and clinical innovation. The various stakeholders need to come together to create an infrastructure that is better, faster, and cheaper instead of making every entrepreneur re-invent the wheel.