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Encouraging Innovation: Drug Discovery and Clinical Trials

Service Design

Orchestrating experiences in context

A column by Laura Keller
December 5, 2016

As experience designers, we love solving messy, wicked problems. Therefore, many experience designers are now focusing on fixing problems relating to healthcare. We’ve made great progress in improving the healthcare experience. We’re using journey mapping to streamline and improve healthcare providers’ processes—for example, hospitals’ check-in and discharge processes and pharmacies’ processes for dropping off and picking up prescriptions. We’ve designed new channels that let healthcare providers communicate with their patients. We’ve helped make clinics’ physical spaces more warm and welcoming.

No doubt such improvements have made the experiences of being a patient or caregiver better. In fact, many of us have experienced these improvements personally. But there is a healthcare process that, while much less visible and tangible to the average person, offers the possibility of dramatically improving people’s health once we solve it: clinical trials.

Clinical trials and the drug-discovery process overall enable pharmaceutical companies, medical-device companies, doctors, hospitals, and researchers to innovate new and improved ways of treating and caring for people. However, the clinical-trial process is significantly flawed—both for the organizations driving such trials and for patients—so much so that innovation has stalled.

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In this column, I’ll first describe the current challenges of the drug-discovery process—focusing primarily on clinical trials. Then, I’ll explore how we can apply more holistic, people-minded, design-thinking approaches and emerging technologies to such a highly scientific and research-driven field to improve the clinical-trial process, encourage innovation in pharmaceutical treatments, and improve health outcomes.

Understanding Clinical Trials

The purpose of clinical trials is to add to our medical knowledge. Common reasons for conducting a clinical trial are to evaluate drugs, medical devices, or new approaches to surgery; find ways of preventing the initial development or recurrence of diseases; find new approaches to identifying or diagnosing specific diseases; or explore ways of improving quality of life for people with chronic illnesses. [1]

A principal investigator is the stakeholder who leads a clinical trial and is usually a doctor. Other stakeholders, or investigators, include a research team that usually comprises doctors, nurses, social workers, and other healthcare professionals. Organizations of various types may sponsor or fund clinical trials—for example, pharmaceutical companies, academic institutions, or government agencies. [1]

During the early discovery, development, and research phases that precede clinical trials with humans, investigators explore and finalize a treatment, device, or approach. Their research ensures that any treatment, device, or approach that proceeds to clinical-trial phases will have no toxic or otherwise harmful affects on humans. [2] Nevertheless, despite these early research phases, clinical trials are still scientific experiments whose outcome is unknown at the start, so they must follow the U.S. Food and Drug Administration’s (FDA’s) rigorous, phased approach to ensure the safety and efficacy of a drug or device both prior to and after its reaching the market. [3] During clinical-trial phases, the research team follows a detailed research plan, or protocol, which is based on what they’ve learned during the initial discovery, development, and research phases that precede a clinical trial. [2]

Once the investigators and developers think they’ve gathered sufficient data—usually through multiple rounds of research—to validate that their drug, device, or treatment is safe and effective, they can apply to the FDA for approval to market the product for its intended use by the population they’ve studied. [2]

The Causes of Stagnant Innovation

While the clinical-trial process is rigorous—thus, helping to ensure the safety and efficacy of new treatments—tremendous challenges exist in the management of clinical trials. This has led to a stagnant pipeline of derivative treatments, so there has been very little innovation. Specifically, regarding drug discovery and development:

“Making new medicines is a difficult business. The drug development process is risky, expensive, and time consuming: fewer than 20% of drugs tested in clinical trials win FDA approval, and it costs approximately $1.2 billion to produce a new drug in a process that spans 12 years, on average. Together, these factors may contribute to the somewhat conservative nature of drug development today, one that too often delivers me-too drugs that use an established approach to fight disease….

“A 2013 report from the FDA suggested that only 40% of new drug approvals over the past two and a half decades represent truly innovative medicines. These so-called first-in-class therapeutics have the greatest potential to transform patient outcomes because they establish new approaches to fighting disease. The remaining 60% work through pre-existing approaches and are, therefore, likely to yield only incremental improvements.” [4]

Contributing to these risks are the very real, tangible challenges of patient recruitment into clinical trials. The Coalition for Clinical Trial Awareness exists to address this very issue. They cite compelling research that demonstrates the significance of this problem, as follows:

“A recent study conducted by the Tufts Center for the Study of Drug Development, involving 150 clinical trials and nearly 16,000 study sites, found that 11% of sites fail to enroll even one patient and 37% do not meet their enrollment goals.” [5]

The financial impacts of recruitment delays on the timelines of sponsoring organizations are severe.

“It is a poorly kept secret in the world of clinical trials that issues with patient recruitment and enrollment are the primary causes for missing clinical-trial timelines…. We know that, for each day a company goes beyond the planned deadline for a clinical trial, that company could be losing as much as $600,000 in foregone sales of similar products and as much as $8 million on blockbuster drugs.” [6]

These delays just add to the already volatile nature of clinical trials for companies that are trying to innovate.

I want to emphasize the human impact of such statistics: The severity of a company’s financial risk for the failure of a treatment during its clinical trials has become so high that many companies are no longer willing to take the risk. When companies stop trying to advance our medical knowledge, they limit everyone’s overall health and quality of life.

Digging more deeply into the stagnant state of innovation in drug discovery and development, we can see that the field is ripe for disruption. We need to optimize the clinical-trial process in a way that safeguards patients, but also decreases the risk of an unknown outcome for a trial. We need to use better technology to improve the quality and availability of the data R&D teams need to complete their work. We need to consider patients not as the objects of our experiments, but as individuals with unique needs and concerns.

Fortunately, organizations have begun to recognize the need to change this status quo and are realizing that focusing on design thinking, open access to reliable data, and the use of emerging technologies are key to making this transformation.

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Emphasizing Failing Early and Sharing Data

Current shifts in the clinical-trial process include more emphasis on the earlier, preclinical phases of drug discovery and on understanding the biology behind health conditions. The hope is that, by focusing on earlier, preclinical stages of treatments, we may be able to quickly test concepts, increasing R&D productivity and alleviating financial risk.

“The time and cost of drug development can only be reduced through making the preclinical phase more effective by predicting which compounds will succeed and which will fail in the clinical phases. This preclinical phase is where innovation occurs, and it has been demonstrated that creating more optimized leads that can be tested faster to deliver proof of concept is likely to increase the probability of phase 2-clinical study success by 50 percent…. The likelihood of success may well be dependent on a quick-win, fast-fail model, requiring the ability to analyze and model data effectively and accurately. Pharmaceutical companies can significantly improve innovation and reduce their attrition rates by learning from previous experiments, gleaning insights from the massive body of scientific data available to researchers today.” [7]

This approach should sound familiar to any UX professional: test early, fail fast, develop proofs of concepts. Companies are now applying core components of design thinking to the drug-development process—without their necessarily realizing it. The outcome is that we’re seeing amazing disruption in an otherwise rigid, scientifically driven, linear endeavor.

However, this new approach to drug discovery relies upon the sharing of data across different companies’ R&D teams, allowing greater access to diverse sources of information than individual teams could otherwise leverage. Historically, pharmaceutical companies have been very secretive about their R&D activities and insights.

But, in 2014, the Accelerating Medicines Partnership (AMP) established cooperation between the National Institutes of Health (NIH), the FDA, ten biopharmaceutical companies, and multiple non-profit organizations. Their goal is as follows:

“To transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets for therapeutics…. Partners are sharing expertise and resources—over $230 million—in an integrated governance structure that enables the best-informed contributions to science from all participants. A critical component of the partnership is that all partners have agreed to make the AMP data and analyses publicly accessible to the broad biomedical community.” [8]

Thus, not only are R&D teams disrupting the process of drug discovery, they are fundamentally changing their attitudes about transparency regarding their insights and cooperation among competitors.

Leveraging Technological Innovations

Obviously, investment in emerging technologies is necessary for any organization’s development efforts to succeed. The adoption of this new drug-discovery model and the changing behaviors of research teams and pharmaceutical companies represents the attainment of a huge milestone, but we also need technology innovations that support these new ways of conducting research. One very exciting technology some pharmaceutical companies are using is 3D printing.

“Using 3D bioprinted tissues, pharmaceutical companies can speed up the drug-discovery process, allowing R&D teams to test new and promising drugs on functional human tissues during early stage and preclinical phases.… While the current drug-discovery process typically takes between three and six years, this innovation would help pharmaceutical companies reject an ineffective or dangerous drug in a matter of months.” [9]

As we better understand the biology of diseases and the importance of individuals’ unique DNA, next-generation genome sequencing will advance treatment innovations.

“In recent years, a crop of companies [has] emerged that are using genomic sequencing to detect diseases in order to prevent the negative outcome of those diseases. It’s led to a budding ecosystem of startups that are crunching the data, as well as the cost of that sequencing coming down … and … applying machine learning to get a better analysis of the genome and catch potential problems earlier.” [10]

So, while innovation is happening on the R&D side of drug development, technologies with which patients interact directly are both aiding the scientific process and improving the patient experience. In particular, apps that monitor a user’s health—employing the sensors of mobile and wearable devices—are providing tremendous value.

“One of the most exciting capabilities of mobile health technology is the real-time data collection feature of some wearable devices and mobile apps. These features make data collection of everyday activities, such as exercise and sleep habits, more continuous and likely more accurate. Mobile apps allow participants to complete surveys in real time, reducing recall bias. Patients can also self-track health-related items like blood pressure, diet, and more using commercial wearables or FDA-approved medical devices.

“These mobile health capabilities could ultimately lead to a decrease in clinic visits or follow-up phone calls for participants, making it easier and more cost effective for people to participate in a clinical trial. It could also increase the scope of a trial by allowing individuals to participate from a greater distance, as travel requirements are reduced. This can lead to a more representative population by making it easier for people from rural areas to be involved in a study.” [11]

With the emphasis on sharing information across organizations, advances in 3D printing and genomic sequencing, and the move to mobile health monitoring, clinical-trials teams need ways to store and manage all of this data.

“Cloud-based platforms, for example, offer unified operating models that can facilitate the processes of designing and managing clinical trials, as well as knowledge sharing and collaboration among users, sponsors, CROs [Contract Research Organizations], and other trial partners…. Such platforms can aggregate patient data across studies and drug programs, allowing life-sciences companies to benefit from quick and easy access to relevant, high-quality, and analysis-ready data. And as we move beyond the clinic to incorporate data gathered from patients’ mobile devices, a single technology platform can capture richer data sets—without increasing the cost of monitoring and data cleaning or the burden on clinical trial sites.” [12]

Taking a Holistic View of Clinical Trials

While these clinical-trial process improvements and technological advances have been impressive and should facilitate greater innovation in drug discovery, their ultimate ability to transform the industry is limited because they do not consider the human side of the process. Only when the drug-discovery industry looks at the challenges of its clinical-trial process from the perspective of the patients and healthcare professionals who are its key stakeholders can real transformation happen.

As I mentioned earlier, the enrollment of patients in a clinical trial presents significant challenges to the company leading the effort. The predominant reason for this is a general lack of awareness of clinical trials among potential patient participants. Physicians are the key to creating such awareness.

“In a nationwide survey of approximately 1,000 adults, 40% did not fully understand the concept of a clinical trial…. Healthcare providers play an important role in raising awareness about the option of clinical-trial participation. By having a focused conversation about treatment options, including clinical trials, a patient can be made aware of and invited to enroll in a clinical-research study: 77% of patients who participate in a trial learned about it from their healthcare provider, [and] 32% of patients who participated in clinical trials reported that their healthcare providers took the time to explain the trial clearly” [13]

However, by digging deeper and doing some root-cause analysis, we’ve discovered that physicians themselves experience barriers in trying to enroll patients in clinical trials. Many are unfamiliar with active clinical trials. Some feel that the research protocols are too rigid, unnecessarily limiting the patients who could be candidates. Others express ethical conflicts between their serving as the clinical-trial participant’s doctor and their patient’s risk in trying a new treatment. Finally, they sometimes feel unprepared to speak knowledgeably about clinical trials and, thus, unable to provide the complex information they must convey to obtain their patient’s consent. [14]

But, even if a doctor is aware of a trial, believes a patient might be a good candidate, and successfully engages the patient in a dialogue about that treatment option, additional barriers to enrollment remain. Common concerns that clinical-trial participants have expressed include the following:

  • “I’m afraid of feeling like a guinea pig.”
  • “I fear the unknown—what are the benefits versus potential risks and side effects.”
  • “I’m unsure of the added cost of participating in the trial.”
  • “I wonder how much of a burden this will be on my family, my work life, and me.
  • “I don’t understand the language of the trial materials.”
  • “I don’t know what happens with my care after the trial is over.”
  • “I’m already dealing with this diagnosis and don’t want the added burden of a clinical trial.” [14, 15]

Patients’ emotions are very real and, if companies fail to consider their significance, focusing only on the science of drug discovery rather than appreciating the emotional complexities at play when patients are considering participation in a clinical trial, patient enrollment in such trials will continue to be a key problem.

Even once a patient has met the research-protocol criteria and decided to participate in a clinical trial, there are still challenges: Exact compliance with the prescribed treatment is critical to the integrity of the trial. Patients’ must feel that healthcare providers are treating them with respect—not looking at them as a subject in a clinical trial. This is important to keeping patients engaged, according to research by the International Society for Pharmaceutical Engineering:

“Patients perceive that the study is of high quality, the staff is professional, and they are a valued part of the process when study staff and/or the pharmacist take the time to review the clinical-trial medicine instructions and periodically check in on adherence. This can be crucial.

“More than one focus-group participant talked of feeling the study protocol was more important than how they were feeling; this seemed to translate into a perception of disrespect and negative experiences. One man said, ‘I think that, at some point, I realized that it wasn’t about my medical care.’ While he completed his study despite his feelings, another focus-group participant dropped out. Whether he would have completed the study had his experience with the staff been better is unknowable. What is known, though, is that those participants who praised the study staff and/or pharmacists generally completed their studies.” [16]

Ensuring that healthcare providers treat patients with respect, communicate with them clearly and empathetically, and give them sufficient one-on-one support throughout the process is critical to patients’ compliance during a clinical trial.

Capitalizing on Opportunities for Drug-Discovery Innovation

Sharing data openly across companies, testing ideas and failing early to improve long-term results, and making technological advances that support drug-discovery innovation are contributing significant momentum to such endeavors. However, the impacts of these gains in drug-discovery innovation will be severely limited if we fail to take into account the needs, behaviors, emotions, and preferences of the full ecosystem of people who are affected by drug-discovery efforts.

We need to consider the doctors, who are the gatekeepers to enrolling patients in clinical trials and own the relationships with patients. Therefore, when R&D teams are designing clinical-trial protocols, they should work with representative doctors, who can simulate patient scenarios and test their pragmatism for patients in the real world of healthcare. When publishing information about active trials, companies can’t expect doctors to be proactively looking for trials. Rather, with the abundance of data that exists today, we should automatically make matches between patient profiles and potential trials, then proactively notify physicians and staff about them.

We need to consider the patients, not solely as subjects in an experiment, but as important participants in the scientific process—as people whose needs, behaviors, attitudes, and emotions are as important as the research protocol itself. This means making sure patients are aware of possible clinical trials, clearly articulating their value to them; educating them on what it means to participate in a clinical trial, using simple, empathetic language; explaining what they can expect before, during, and after the trial; and giving them as much support as they need to stay compliant, by whatever means they prefer.

However, merely thinking about the patient experience of the drug-discovery process in this way will not push the industry far enough to deliver significant innovations. But, rather than just evaluating a trial’s results against a research protocol and predetermined metrics for safety and acceptable side effects that people who neither require nor take a drug themselves have defined, what if we sought the patients’ input on what a successful drug would look like to them? We could make the patients true contributors to the drug-development process and empower them by giving them a voice in the clinical aspects of the process.

“It is time to change this system that keeps patients out of the drug-development process and include the patient perspective in determining the type of drug side effects and risks [that make] going forward [worthwhile] due to overall health benefits. It is important for drug developers to take into account whether the potential advantages of a medication outweigh the risks and incorporate the patient perspective into these decisions…. The purpose of incorporating the patient experience into the regulatory approval and clinical use portions of drug development is to ensure the products are truly beneficial for the end users themselves.” [17]

The drug-discovery and clinical-trial processes are the kinds of messy, wicked problems that experience designers love to tackle. Their impact may not be as obvious or tangible as improving emergency-room waiting-room queues or finding new ways to let patients make appointments or notify them about appointments. But clinical trials are a fascinating sector of healthcare that would benefit from innovative thinking and a people-centered mindset.

As experience designers, we can help map stakeholder and user journeys, orchestrate new processes, plan the best ways to facilitate communications, determine the most purposeful uses of new technologies, and most importantly, discover ways to connect people more closely to the science of medicine. 

Endnotes

[1] National Institutes of Health. “Learn About Clinical Studies.” ClinicalTrials.gov, December 2015. Retrieved November 9, 2016.

[2] U.S. Food and Drug Administration. “Learn About Drug and Device Approvals.” FDA.gov, June 24, 2015. Retrieved November 8, 2016.

[3] U.S. National Library of Medicine. “Clinical Trial Phases.” NIH, April 18, 2008. Retrieved November 8, 2016.

[4] Downing, Nicholas. “Promoting Innovation in Drug Development.” Yale University Institute for Social and Policy Studies, undated. Retrieved November 6, 2016.

[5] Coalition for Clinical Awareness. “About Us.” Coalition for Clinical Awareness, undated. Retrieved November 8, 2016.

[6] Industry Standard Research. “The Expanding Web of Clinical Trial Patient Recruitment.” (PDF) ISRReports, March 2014. Retrieved November 8, 2016.

[7] Geoui, Dr. Thibault. “Building a New Golden Age of Innovation in Drug Development.” Drug Discovery & Delivery, December 2, 2015. Retrieved November 7, 2016.

[8] National Institutes of Health. “Accelerating Medicines Partnership (AMP).” NIH, undated. Retrieved November 8, 2016.

[9] Clarkston Consulting. “The Impact of 3D Bioprinting on the Life Sciences Industry.” Clarkston Consulting, undated. Retrieved November 8, 2016.

[10] Lynley, Matthew. “Figuring Out What Comes After Gene Sequencing in China.” Drug Tech Crunch, November 7, 2016. Retrieved November 7, 2016.

[11] Schultz, April. “mHealth: Is Mobile Technology Right for Your Clinical Trial?Forte Research Systems, April 26, 2016. Retrieved November 5, 2016.

[12] Myshko, Denise. “Disruptive Technology: The Keys to Pharmaceutical Innovation.” Forte Research Systems, November 2014. Retrieved November 5, 2016.

[13] National Institutes of Health. “NIH Clinical Trials and You.” NIH, undated. Retrieved November 8, 2016.

[14] Williams, Sandra. “Clinical Trials Recruitment and Enrollment: Attitudes, Barriers, and Motivating Factors.” (PDF) Rutgers University, August 2004. Retrieved November 5, 2016.

[15] Geeks Talk Clinical. “In Clinical Trials, Does the Patient Experience Matter?Geeks Talk Clinical—Medidata Solutions, December 10, 2013. Retrieved November 7, 2016.

[15] Gruessner, Vera. “Should Clinical Trials Include the Patient Experience?mHealthIntelligence, October 22, 2015. Retrieved November 7, 2016.

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Director of Strategy & Experience Design at NTT Data

Woodbridge, New Jersey, USA

Laura KellerLaura’s 10 years of experience have focused on representing the human element in any interaction with a brand through actionable, business-impacting insight gathering and design. At NTT Data, Laura leads cross-channel experience design strategy engagements for clients. Clients have included AstraZeneca, Hachette Book Group, GlaxoSmithKline, Prostate Cancer Foundation, Honeywell, and the NBA. In addition to her Service Design column for UXmatters, Laura has written articles for the Service Design Network’s Touchpoint: The Journal of Service Design, User Experience Magazine, Communication Arts, and Johnny Holland. She has presented on service design at SDN’s Global Service Design Conference, the Usability Professionals’ Association International Conference, IxDA New York City, and IxDA New Jersey.  Read More

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