Made to Measure

Pharma needs to measure the patient-centricity of its clinical trials as accurately as any other variable, says Professor Michael Howley



Patient-centricity has been a buzzword in pharma for some time now but it is still met with a fair share of skepticism. As with any exciting new trend, there will always by the fear that it is just the latest passing fad to be ignored or paid lip service.

While many companies have taken action, some have not gone far enough, says Michael Howley, Associate Clinical Professor in the Department of Marketing at the LeBow School of Business at Drexel University.

“The corporate response has often been to appoint a patient centricity officer, to get their opinions and feedback, and think ‘great, we are now a patient-centric company’. It’s a bit more challenging than that,” he says.

In order for patient-centricity to reach its full potential, it must be measured as accurately and as honestly as any other variable in drug development, says Howley. “Once we can measure the patient-centricity of each trial, we can begin to understand how management interventions affect patient-centricity levels, and provide a scientific foundation on which [it] can continue to develop and grow. But this vision all depends on a valid and reliable measurement.”

We have to measure the quality of clinical trials, he says. “If you get the measures right, then it becomes like a bridle on a horse – you can then lead and manage the horse. If we can get the measures right in a clinical trial, then we can manage the quality of the trial. Without the right measures, you are blind.”

Patient-centricity is an important piece of overall trial quality. If you are not responding to the need and values of patients then you are not executing a clinical trial. If your measures and endpoints in the trial are not meaningful to patients, then that will affect the quality of the clinical trial. If you are not taking care of the patients in the trial, then that isn’t a quality clinical trial.

For Howley, who admits to being a ‘measurements person’ not a clinical researcher, industry may believe it has achieved quality in clinical trials, but the reality is far from it. In a recent article published in Applied Clinical Trials, he presented the case for viewing patient-centricity as a measure of quality, saying it should be integrated into an ongoing quality measurement program.

He explains: “Patient-centricity is an important piece of overall trial quality. If you are not responding to the need and values of patients then you are not executing a clinical trial. If your measures and endpoints in the trial are not meaningful to patients, then that will affect the quality of the clinical trial. If you are not taking care of the patients in the trial, then that isn’t a quality clinical trial.”

Dumbing down

Industry has dumbed patient-centricity down and a “Survey-Monkey” culture has developed where everyone is able to collect data without really understanding what they are measuring, says Howley.

“Industry doesn’t know how to validate these types of measures. There are industry consultants who whip these surveys up without any training on the right way to do it. We should think about what we are measuring.”

We also need to be efficient in our data collection, he says. While patient-centricity measurement is related to both trial design and patient care, industry often confuses it with patient satisfaction scores. Collecting unrelated data or undisciplined sampling adds inefficiency, is a waste of money, adds unnecessary complexity to the  analysis, and generates biased information that obscures managerial judgment, he says.

Another pitfall is relying on existing data to measure patient-centricity. “Industry has a lot of this kind of data lying around but you can’t just use it without establishing what you are measuring. You risk measuring the wrong thing and then being provoked into misguided actions.”

With the scientific approach to measuring patient-centricity still in a “primitive state”, he and his colleagues are working to develop specific measures. However, it’s early days even for them and his working group is still at the point of preparing to collect data.

Howley admits that there is “a tremendous risk” of incorrect measurements. “If you take the example of clinical trial quality, for the past 15 years the clinical trials industry has spent billions and billions of dollars every year to improve the quality of clinical trials. Yet, just 8-10 percent of clinical trials will come in on time and budget. Much of this problem is related to the fact that we are still not correctly measuring quality, so our interventions miss the mark.”

Despite spending all this money, industry is not improving the quality of trials – this is in addition to the lost research productivity in patients that are exposed to low quality clinical trials.

What next?

In a bid to avoid any misteps, Howley advocates what he calls a straightforward three-step process that managers can use to begin their patient-centricity measurement programs. This involves getting patient feedback, assessing trial design, and assessing patients.

While this involves hard work, most of the challenges lie in the sampling process, he says. "Getting the right instrument to the right person is the challenge, but this can be expedited with cloud-based administrative technologies".

Analyzing patient feedback is one thing, determining how best to respond is another, he adds. "As you begin to gather patient-centricity assessments, it is worth considering how your organization will act on the feedback." He envisions continuous feedback; as a trial unfolds, patient-centricity can be measured. "As we see problems, we can intervene to improve it."

This is not simply an academic endeavor and Howley is working with CRO Analytics on the management structures needed to best execute his approach. "We have companies that have committed to it and we are still open to accepting other companies. There is a lot of interest," says Howley.

The co-author of the Applied Clinical Trials article, Peter Malamis. Is CEO of CRO Analytics and is soliciting collaboration from interested companies in the Patient View Advisory Board, to establish the optimal scientific approach to measuring patient-centricity. Anyone interest, can email pmalamis@croanalytics.com.

The purpose of his article in Applied Clinical Trials was to lay out the scientific approach for measuring and managing the patient-centricity clinical trials in a bid to stop patient-centricity drifting toward the perception of being simply a fad, he says.

“There has to be a scientific measurement – we can do this but we have to stay on the scientific basis. We can’t just head for Survey Monkey or use other data sources because it’s easier.” Howley calls this is a necessary move – should it be mandatory? He thinks is should be, and adds that he is “surprised” that sponsors and funding agencies would be willing to move forward on patient centered interventions without measuring if they are improving the patient-centricity of the trial. “Unless they measure it, how do they know what they are doing?”

 

Howley's three-step process to measure patient-centricity

1. Get patient feedback

The critical success factor here is to collect the right data; remember, patient-centricity is not patient satisfaction. Start your patient feedback program by collecting data on patient engagement (i.e., how responsive the providers were to patients’ needs, values, and preferences) and patients’ perceptions of the quality of the trial. Include patients’ perceptions of the quality of the study – it is more useful to measure patient perceptions early in the trial, then periodically throughout the trial, rather than solely at the end.

2. Assess the trial design

While there are no established instruments available for assessing trial design, new assessments will need to be validated to provide scientific measurement. Fortunately, the Patient Centered Outcomes Research Institute (PCORI) has identified the topics and issues to be addressed within a trial-design assessment. These include four components: planning the study, conducting the study, disseminating the study results, and adherence to the PCORI engagement principles. Patients and partners (eg, family members, caregivers, patient advocacy organizations) should be sampled, without relying entirely on partners with multiple roles.

3. Assess patients

Patients must play a part in order for a trial to be considered patient-centric, and the degree to which patients are able, willing and motivated to do their part is called patient activation. Patient activation should be measured at the start of the trial as a baseline and then periodically across the study. How activation changes over the course of the trial will reflect the impact of the clinical site and provider interactions with the patient.

 
 
 
 

This article is extracted from Trends in Clinical Data & Technology. To download the magazine, click here.

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