Trials without Tribulations
As medicine grows more precise and personal through genomic intervention, drug development finds itself challenged by traditional, inefficient approaches to clinical trials. Indeed, innovation and medical understanding have outpaced the processes set in place long ago by regulators.
What’s a pharma company to do?
One effective way to drop-and-drag drug development into the 21st century: decentralized clinical trials (DCTs). The FDA defines DCTs as clinical trials that are “executed through telemedicine and mobile/local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model.” DCTs have been discussed widely for at least a decade, but for many years the FDA was at best indifferent to their potential value, due to various concerns about patient data privacy and security.
However, any lingering reticence the FDA may have harbored about using DCTs was eliminated in March 2019, when a statement from then-FDA Commissioner, Dr. Scott Gottlieb, was issued advocating for their increased use.
In collaboration with the Clinical Trials Transformation Initiative, these DCT benefits were highlighted:
- Increase recruitment speed
- Improve participant retention
- Make trials more convenient, comfortable and empowering for participants
- Improve diversity of participant groups
But, as the FDA stated, these benefits can be elusive. “[T]hese opportunities can be delayed or stymied by a clinical research enterprise that is often extraordinarily complex and expensive,” said Gottlieb. “Efforts to streamline medical product development based on advancing science can be frustrated by legacy business models that discourage collaboration and data sharing and the adoption of disruptive technologies that make clinical research more effective.”
So, what can sponsors and CROs do to increase their chances of capturing the range of benefits that DCTs can potentially offer? The following potential actions and behaviors should be considered as part of a successful DCT program deployment.
Collaborate. While the FDA likely was referring to collaboration and data sharing among various organizations across the public and private sectors, it’s important that sponsors start collaborating within their own organizations across therapeutic areas. Note that the positive effects of DCTs are not aligned to a specific therapeutic area; these benefits are applicable, at varying degrees, to all disease units. Disease units can learn from each other how changes in process, new training programs and new software deployments have affected their programs—and other areas can take note as they deploy a DCT program within their own unit.
Think Beyond Technology. Implementing what may be considered a disruptive technology has far-reaching implications, apart from deploying the advanced systems. These technologies will affect the way key stakeholders perform their jobs. They can require a thoughtful organizational change management program, including robust training programs tailored uniquely towards various personas in the clinical trial journey.
Consider HCP and Clinician Adoption. A quick web search on ‘patient centricity in clinical trials’ yields dozens of results that detail how a focus on trial participants is essential for success. If, however, you swap out the word ‘patient’ with ‘provider’ or ‘HCP,’ the results are dismal. In the industry’s drive to make clinical trials more patient-friendly, is it possible that the needs of HCPs and other clinicians have been neglected?
A recent conversation I had with a researcher-physician on this topic provoked the following, strong response. “I did not get into the healthcare profession to engage patients over video conferences,” she said. “I want to see and hear patients in my office and expecting a large portion of our community to embrace this technology without adequate training and education on how these technologies can best be deployed and assist both doctors and patients, is simply too big of an ask.” The bottom line: While achieving patient-centricity is important, other key constituents in the clinical trial journey cannot be left behind.
Reach Out to Minority Populations. During a time when pharmaceutical executives are hauled before Congress and asked to explain and defend drug pricing policies, how can the industry expect a greater willingness and participation in clinical trials, especially from minority communities? You know the problem is severe when even though heart conditions disproportionately affect the Black population, they are accounted for only 2.5% of clinical trial participants in a global trials report by the FDA. Outreach programs that start at recruitment and engage community leaders, not just potential participants, and include digital and traditional channels, are a critical exercise if the clinical trial participant population ever hopes to be representative of the actual larger population demographics. An absence of these programs may limit any potential benefit DCTs may have in reaching diverse populations.
DCTs, in conjunction with other major advances in the drug development journey such as artificial intelligence and machine learning, have the potential of providing sponsors an enormous amount of benefits that translate into significant cost and time savings. A thoughtful, holistic and comprehensive DCT deployment program can provide sponsors an excellent chance to realize these benefits and significantly reduce the time it takes to deliver life-enhancing and life-saving drugs to the market.
