The benefits of patient-centric clinical trials, the role technology can play, and why it is worth shifting the industry’s mindset to put the patient at the center of studies.
The necessity for clinical trials to meet regulation requirements, deliver high efficacy data, and stay within the budget has led to study designs that isn’t as receptive to change. This type of mindset misses out on trial optimization opportunities and may burden and inconvenience patients.
Today, priorities are shifting as sponsors finally realize that studies designed around the needs of patients also bodes beneficial to other stakeholders. This discovery has led to an increasing interest surrounding patient-centric clinical trials.
Introduction
The burdens of clinical trial participation are well documented in prior studies. Traveling to trial sites, complying with medication regimens and procedures all create strains on patients, leading to low retention rates and participants not complying with the protocol. What is changing is the willingness of sponsors to redesign their studies around patients and the recognition of how this benefits everyone.
Sponsors’ shifting attitudes are underpinned by empirical proof that the current system is flawed. According to a survey of 3,150 people by the Center for Information and Study on Clinical Research Participation, more than one-fifth of trial subjects find the experience somewhat or very stressful. Asked what they liked least about the experience, people cited the location of the medical center, the time-consuming nature of study visits, and the cumbersome procedures they had to follow.
The consequences of these experiences extend beyond patients. Sponsors need people to want to enroll in trials and take their medication per protocol if they are to gather high efficacy data in the fastest time possible. Yet, trials designed without considering the needs of patients are unlikely to achieve optimal enrollment, retention, protocol compliance, and medication adherence rates.
Addressing this, sponsors are increasingly building the patient perspective into all aspects of their clinical trials. Sponsors that take the time in preemptively designing patient-centric clinical trials are ultimately rewarded significant benefits.
What does patient centricity mean in the context of clinical trials?
Patient centricity is an industry buzzword right now, garnering a lot of attention in the pharmaceutical community. Frankly, it means a lot of different things to a lot of different people. Specifically within the clinical trial community, we’re seeing people taking a step back from the traditional thinking of what’s most cost-effective or most immediate and shifting to a broader perspective of what’s most effective for the patient. As the industry reevaluates, they’re finally realizing that focusing on the patient ultimately reflects in the efficacy of the trial’s data that leads to additional benefits that far outweigh the short-term implications.
What sort of benefits can companies realize through patient centricity?
Patient centricity leads to more focused clinical trials with better participant retention, better engagement with the study, and better adherence to the medication and protocol. Keeping more patients in a trial and monitoring that they’re taking their treatments as per the protocol can significantly reduce the trial duration and improve the quality of the data being gathered. These substantially outweighs any considerations of short-term advantages of not implementing any new methods to optimize the study.
What role can technology play in making trials more patient centric?
Leveraging technology and implementing it to clinical trials is a beneficial method for communication and data collection. A device-enabled integrated platform that captures dosing events provides real-time information for the people administering the trial. The quality of data being gathered is extremely powerful, particularly in an adaptive study scenario, where the study proctor can act upon a non-adherent subject much more quickly than a traditional study where data may lag substantially and crucial opportunities for enrichment interventions are missed. This type of visibility can also be beneficial for Phase II-IIIb studies, where the participant is not taking the medicine in the presence of someone; and studies in high toxicity therapy classes and narrow PK profiles such as Oncology, Hep C, and ALS.
How does technology benefit patients and other stakeholders?
It improves the patient’s chance of medication adherence and engagement in the trial. This could significantly increase better patient outcomes. For sponsors and CROs, this results in enhancing the study’s efficacy data available in real-time, more cost-efficient trial, and ultimately faster next phase approval.
Furthermore, the people administering the study benefit from having consistent patient populations that are educated and have the best chance to positive results. Retention rate will also increase because of the non-invasive approach utilizing a device-enabled platform. It also allows the study proctor to better understand the results of the study in the outpatient setting. It’s a situation where everybody wins.
More broadly, how can companies maintain their focus on patient centricity?
It will require a fundamental mindset shift for the industry to ensure that the patient’s interest is at the highest level from the beginning. Sometimes that mindset will create inconveniences for the people administering the study because of certain implementation approvals or add additional costs upfront.
In the long run, the benefits for both patient and stakeholders, including the financial impact far outweigh any of the short-term costs. There’s a lot of value-added advantage for sponsor companies and CROs in making sure the patients’ interests is addressed at the forefront of research and development.
