The global economy, catalyzed by technology, is becoming increasingly consumer-centric. Social media and mobile applications are putting the ball in the customer’s court across industries ranging from transportation to legal counsel to hospitality. The clinical research industry has its analogy to this trend in the rise of patient engagement. A recent eyeforpharma report notes that the vast majority of pharmaceutical executives champion patient engagement in clinical trials1, and the industry has reacted to this consensus with technological innovations and increased interactions in an effort to keep patients pleased, comfortable, and incentivized to participate.
As sponsors and CROs continue to invest more resources into ensuring patient satisfaction and analyzing patient reported outcomes (PRO), it is becoming clear that patient engagement is claiming its place as a defining component of modern clinical research.
What patient engagement can look like
The methods used in the approach to patient engagement are numerous. On a broad scale, there have been efforts to reach out through mobile technology or social media, with objectives ranging from enhancing recruitment strategies to making the patient compensation process more convenient. When it comes to the conduct of the trial itself, one approach to engagement has been satisfaction surveys. The U.K. recently began requiring satisfaction surveys in clinical trials; a group of healthcare professionals writing for Applied Clinical Trials described their presentation of a satisfaction survey to 181 Phase I patients, and called for others in the research community to follow their lead2.
Another approach has been advancing methods for gathering PRO. As patients provide information about their quality of life and any adverse events they experience during the course of a clinical trial, researchers find themselves with a new wealth of data with which to develop more detailed and personalized treatment plans. This demonstrates the value of patient engagement not simply for ensuring satisfaction and boosting recruitment, but for the actual medical work at the heart of a trial. Researchers have come to increasingly value PRO after it has proved useful in recent trials for painting detailed pictures of the safety- and efficacy-related effects of different treatments on different patients3.
This growing trend toward patient engagement, both through technology and communication, has fed innovation in areas adjacent to the clinical research industry, including to the EDC industry. Medrio, for example, recently released mPRO, a tablet application designed to collect PRO in the clinic. By applying eSource technology to the process of gathering PRO, products like this cut paper out of the equation, enabling significant reductions in cost and error risk and more comprehensive analysis of patient experience.
The need for engagement in Phase I
Perhaps no area of clinical research has more reason to value patient satisfaction than Phase I. In part, this owes to the recruitment of healthy volunteers. Subjects in the later phases of clinical research, who typically have been diagnosed with the ailment at the heart of their trial, are largely motivated to participate by the possibility of receiving a new, otherwise unavailable treatment; this motivation is absent in healthy volunteers2. A failure to ensure the satisfaction of Phase I patients–whether that means keeping them comfortable and informed, or assuring them of the expertise and attention of site staff–can alienate a patient population who already lacks the medical incentive of participants in other clinical phases. The result can be high dropout rates or a lack of interest in participating in future trials.
Both because of the small size of Phase I trials–with only 20 to 80 patients, the effect of patient dropout on Phase I can be particularly acute–and their role as the basis of all in-human research into a treatment, this is not a risk worth taking. The acquisition of data that is used to determine such fundamental points as safety and proper dosage levels depends on Phase I running smoothly. The success of Phase I trials, and the accuracy of their findings, largely determines the course of future research. With all this at stake, it is essential that study personnel engage with patients enough to ensure their continued satisfaction and comfort during Phase I.
As advancements like mobile technology, social media, and eSource fuel the current wave of patient engagement, the clinical trial industry appears to be at the cusp of a new era, one characterized by the same trends as many other industries around the world today: a deference to, and investment in the satisfaction of, the populace driving the industry.
1 Fusco, Kathleen; Need for Patient-Centric Clinical Trials Fuels Adoption of Greenphire’s ClinCard Solution [Press release]; PRNewswire.com; 05 April 2016
2 Sramek, John; Hauptmann, Kurt; Ding, Hong; Fern, Keith; Cutler, Neal R.; Adcock, Sherilyn; Survey of Healthy Participants in Phase I Trials; Applied Clinical Trials, 06 February 2015
3 Inacio, Patricia; Patient-reported OUtcomes in Lymphoma Clinical Trials Are Recognized as Important Tools; Lymphoma News Today; 08 April 2016