Fixing the Clinical Trial Bottleneck by Making Patients a Priority


Xconomy San Diego — 

The world of medicine and drug development has transformed dramatically over the past 50 years. Today, we have biologic medicines, genomic sequencing technologies, and digital health tools that help patients become more engaged in their care.

But one part of the equation hasn’t seen very much change at all: clinical trials.

Clinical trials are a necessary component of bringing any drug to market. It’s during this process that investigational medicines are tested in controlled studies with patients. It’s also where a large chunk of a pharmaceutical company’s drug development budget is spent. A recent analysis in Nature Reviews (password required) put the median cost of a three-phase clinical program at $33.4 million.

Yet even as the medicines themselves have grown more sophisticated, clinical trials have stayed pretty much the same. Paper forms and manual data-collection are still the norm, and patients often must make lengthy trips to clinical trial sites.

These are some of the reasons drug companies struggle to enroll patients in clinical trials. While many patients simply aren’t aware of opportunities to be a part of a clinical trial—or don’t know what their participation would entail—others simply feel that the personal “costs” outweigh the benefits. They feel that their voices aren’t accounted for in the way trials are designed and conducted.

Finally, the drug industry is recognizing that much can be done to innovate clinical research and reduce the patient burden. Smart changes could lower trial costs and help bring drugs to market faster.

Technology is a big part of the solution. We’re seeing a number of startup tech companies— and Clariness, for example, that have built a business around making information about ongoing clinical trials more accessible. Some even offer to pre-screen patients against study criteria, helping to find a match.

Even if these programs succeed in finding more patients for studies, which I hope they do, challenges will remain in connecting patients with study center sites. These sites will need to become familiar with the new Web-based route of patient acquisition, as well as the timely follow-up that’s needed to secure participation.

Once enrolled in a trial, the challenge then becomes keeping the patient enrolled—industrywide dropout rates are estimated at around 30 percent. Technology also is helping to address this part of the equation. Today we have digital sensors that can collect patient data from afar, and teleconferencing options that can save participants a car ride to a trial site. We have online tools that can track trial supplies, and video-based educational materials that help patients understand their role without having to wade through thick pamphlets.

But as all of these tech-driven answers emerge, we must remember that improving clinical trials isn’t just about having the right technology. After all, some of this technology has been around for years, and it’s still not used as standard protocol in trials. The real hurdle is the time and effort needed to validate, reiterate, and implement new solutions at scale—and importantly, in a way that will be embraced by the FDA and other regulatory bodies.

As the pharmaceutical and biotechnology industries look to modernize clinical trials, one principle will keep these decisions centered: Patients are our most important partners.

Perhaps this doesn’t seem like a ground-breaking philosophy. But it is. Patients don’t want to be treated like study subjects. They want to be treated like people with busy lives and family obligations. They want to be recognized for their efforts to participate, often while managing a difficult disease, and acknowledged for doing their part to bring forth a viable treatment.

Whenever a new technology is implemented, it must be done in a way that respects the patient’s preferences and maintains a personal touch. Janssen, for example, is collecting patient input through a variety of means, including patient interviews, surveys, listening socially, and full-on simulated trials that solicit feedback throughout. Based on our learnings thus far, we’ve been able to address pain points in our quest to improve the patient experience.

In one trial, we identified the need for transportation to take patients to their doctors. We’ve also heard that patients want access to their lab results and other health data, so we’ve developed a process for sharing as much as we can as early as we can, without jeopardizing clinical trial results.

The industry consortium Transcelerate Biopharma Inc., which includes nearly 20 biopharmaceutical organizations with a shared vision of innovating clinical research, also continues to pool knowledge to create consistency across the trial spectrum. The spirit of collaboration is a testament to the urgency and commitment we all feel for this cause. We know that if a patient has a negative experience in a trial with one pharmaceutical company, that person likely won’t participate again—and he or she may influence the decision of dozens of other potential clinical trial participants.

Without courageous volunteers in clinical trials, we would not have any of the medicines introduced during the past 50 years. Pharmaceutical innovation would be for naught. If we’re going to fix the clinical trial bottleneck that’s slowing down drug development and adding to costs, we first need to make an investment in our most important stakeholder.

Relationships are everything, even in clinical trials. If we can create more positive patient experiences, enrollment challenges will dissipate.

Andreas Koester is vice president and global head of Janssen Clinical Innovation, part of the Janssen Pharmaceutical Companies of Johnson & Johnson. At Janssen, he is leading industry-wide efforts to modernize trials by prioritizing the patient experience. Follow @

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