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A Framework for Patient-Centered Clinical Trials

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Nov 15, 2013

“People don’t want a quarter-inch drill, they want a quarter-inch hole.” -Theodore Levitt

According to Harvard Professor Clayton Christensen, people hire products or services (like a quarter-inch drill) to accomplish a goal (like a quarter-inch hole). When evaluating opportunities for innovation, improvements need to be considered in the context of helping customers accomplish their goals, or “Jobs-to-Be-Done.”

Does this concept still hold beyond traditional products and services? For example, are Clinical Trials a “product”? Who are their “customers” and for what “jobs” are they currently “hired”? How well do they help their customers accomplish their “jobs” today, and how can the experience of clinical trials be improved to attract more customers and maximize value to them?

Using Christensen’s “Jobs-to-be-Done” framework, we will see that clinical trials are “hired” by both patients and clinical trial sponsors for two very different “jobs” but fail to adequately address the needs of both “customers.” These “jobs” are inextricably linked; trial delays, additional costs, and risk arise for Sponsors because of frictions in the Patient experience. By fully integrating around Patient Jobs to Be Done, Life Sciences companies will enjoy faster and less costly trials with lower risk and higher probability of success.

 

The “Jobs to Be Done” Framework

Christensen often tells a story about milkshakes, which he suggests can be “hired” for multiple “jobs”:

Truck drivers may “hire” milkshakes to “make my morning commute more tolerable,” or a father might “hire” a milkshake to “help me do something nice for my son during our long afternoon car ride.” In the morning, milkshakes compete against bagels, bananas, and even boredom, but milkshakes “win” because they last longer, are more flavorful, easier to consume while driving, and less boring. In the afternoon, milkshakes compete against iPhone apps and other alternatives to do something nice for a child, but milkshakes “win” because apps cannot satisfy a young boy’s food cravings (Apple may be wrong in this case — there’s not “an app for that”).

 

The Challenge of Multiple “Jobs to Be Done” in Clinical Trials

A problem arises when one product is hired for more than one job. For a product to “win” in both circumstances, it needs to excel at helping both sets of customers do their “jobs,” while also exactly providing the desired functional, social, and emotional experiences that each customer desires.

Like milkshakes, clinical trials face this dual-job challenge. Life Sciences companies “hire” clinical trials to get their drugs to market, while patients “hire” clinical trials to improve their health.

For milkshakes, Christensen suggests that something as simple as a straw could bridge the gap to tailor the experience of a milkshake to the unique needs of two customers. Smaller straws could be offered in the morning so milkshakes take longer to drink for truck drivers (making long drives tolerable), while a larger straw could be used in the afternoon so milkshakes would take less time for the son to drink (satisfying his hunger faster).

By understanding the jobs-to-be-done of both life sciences companies and patients in the context of clinical trials, we can begin our search for the “straw” to bridge the jobs and provide a perfect, seamless experience for both.

Why Do Patients Hire Clinical Trials?

In a previous article, Satisfying the Patient’s Jobs to be Done, we suggest that patients have three fundamental jobs related to their health:

  1. “Tell me what’s wrong.” I think I might be sick. Please diagnose me and figure out what’s wrong.
  2. “Fix what’s wrong.” I know I’m stick. Please give me the treatment I need to get better.
  3. “Keep me well.” I have a chronic condition to manage or just want to avoid getting sick again in the future. Help me stay well.

There is evidence that patients “hire” clinical trials to satisfy Jobs #2 and #3, particularly when they perceive that they would receive more effective treatments through the trial than the existing standard of care. According to a survey from ECRI, 72% of patients choose to participate in a study because of potential health benefits or physician influence. In this sense, clinical trials compete with the standard of care or doing nothing as alternative approaches to disease management.

Patients may also hire clinical trials to satisfy altruistic desires, as 18% choose to participate because of the potential to benefit others. In this sense, clinical trials also compete with donating blood, volunteering time to a worthy cause, or contributing money to charity.

Cost, convenience, and reliability are not patients’ “jobs” by themselves. Rather, they are part of the experience of “tell me what’s wrong,” “fix what’s wrong,” and “keep me well” . . . as fast, inexpensively, and reliably as possible. Products and services that satisfy the core jobs with the best experiences will be the ones that consumers and those in their health network will ultimately choose to provide their care.

 

Why Do Life Sciences Companies Hire Clinical Trials?

In another article, Defining Disruptive Innovation in Clinical Trials, we note that Life Sciences companies sponsor clinical trials to help them obtain approval for their new therapies. In this context, they face four fundamental challenges related to Patient Management:

  1. Recruitment: “Help me identify and enroll the right patients.”
  2. Adherence: “Help me ensure that patients follow my protocol.”
  3. Retention: “Help me prevent patients from dropping out of the study.”
  4. Data Capture: “Help me gather reliable patient data quickly and cost-effectively.”

Interestingly, nowhere in these goals is any mention of improving patient health outcomes.

 

Is There an Intersection?

Like milkshakes, clinical trials are hired for two sets of jobs that seem quite disparate. None of the sponsor jobs directly helps patients “get better,” and none of the patient jobs directly helps sponsors “get my drug to market as fast, inexpensively, and reliably as possible.” In other words, life sciences companies need patients to get their drugs to market, but patients do not participate in a trial to help pharmaceutical companies accomplish this objective. Instead, most participate with the sole job of improving their health.

However, there is a “straw” that links these two jobs. As a result of helping patients get better and more effectively manage their diseases, life sciences companies can reduce development costs, conduct faster trials, lower risk, and enhance the expected effectiveness of their therapies. When patients are recruited to a study because a new therapy is predicted to improve their health, they will be less likely to drop out and be more motivated to take their medicines. Consequently, fewer patients will be needed in trials, fewer delays will result from better retention, and the trial will have a higher probability of success.

This suggests that improvements to the patient experience in clinical trials would be sustaining to both life sciences companies and to patients. They are actually hiring each other, in a sense, and clinical trials offer common ground. As long as new therapies get to market and patients gets better, both sides should be motivated to come together.

 

Framing a Patient Management Solution for Clinical Trials

There is a mindset in the life sciences industry that “engaging” patients during a trial can improve adherence, retention, and data quality. We need to be careful not to take a sponsor-centric view of “patient engagement.” Improvements to the patient experience in clinical trials need to be framed according to the patient’s Job-to-Be-Done — to genuinely help them get better, not just to get a drug to market.

Today, only the patients who are most altruistic, in the greatest medical need, or who coincidentally live near investigative sites participate in clinical trials. Only 5% of cancer patients participate in clinical trials, according to Adam Dole (from the White House) and Jennifer Wulff (from Pfizer). Also, the previously-mentioned ECRI survey found that patients did not enroll in (or dropped out of) a study because of high patient burden/inconvenience (25%), concern over experimentation (20%), potential lack of health benefit (19%), and physician influence (14%). These statistics suggest that “clinical trials” as a “product” do not adequately satisfy the jobs-to-be-done of patients.

There are two potential approaches to improving the patient experience:

  1. Focus on improving the experience of patients who are already most likely to participate in a clinical trial (e.g., 5% of cancer patients)
  2. Make clinical trials more accessible and responsive to the needs of people who do not participate in trials (e.g., 95% of cancer patients)

From a sponsor’s perspective, the second approach is likely to have a greater impact on cost, speed, risk, and therapeutic effectiveness but may be more challenging to implement. Clayton Christensen’s theories suggest that addressing non-consumers can only be done through disruption, which often involves a radically new approach. To fully integrate around patients’ jobs-to-be-done, the clinical trial model might need to be “turned on its head” (but that is a topic for another blog post).

For example, one of the greatest challenges for sponsors is recruiting patients. 11% of studies fail to enroll a single patient, and 37% under-enroll. Regarding patient burden, Komathi Stern (from Genentech/Roche) said that only 30% of patients live near current investigative sites, but 80% of patients would join a trial if the site were within 30 minutes of their home. Disrupting sites and running trials in more convenient settings is just one way clinical trials can become more accessible to non-participating patients. We would welcome your ideas in the comments below.


Closing Thoughts on Patient-Centered Trials

If life sciences companies fully integrate around the Patient Jobs to Be Done, we are confident that they will, in turn, address Sponsor Jobs to Be Done. When clinical trials are better able to “fix what’s wrong” or “keep me well,” more patients will be drawn to participate in trials, take their medications, and remain enrolled in their studies. When sponsors can more reliably gather comprehensive patient data, they can conduct less expensive, more targeted trials with lower risk and higher probability of success.

After all, therapies are designed to help patients improve their health. Clinical trials should also be designed with this same objective in mind.

 

Evan Shore is an Adjunct Fellow at the Christensen Institute and Director of Strategy at Medidata. There is no financial relationship between Medidata and the Christensen Institute.  

 

Evan Shore