March 1st, 2017 Patient Centricity in Clinical Trials Explained, Pt. II The second installment in a four-part series on patient centricity in clinical trials – what is it and how can we be doing more to improve outcomes for patients and sponsors alike? Patient Centricity in Clinical Trials Explained (Pt. 1) provided a practical definition for patient centricity, discussed the patient mindset during the path to enrollment, and emphasized the importance of good communication and transparency throughout the entire process. Part II will focus on patient-centric trial design, which, when done properly, can improve patient enrollment and retention outcomes while simultaneously lowering costs across the board. Soliciting Patient Input When Designing Trials and Associated Materials According to Neha Shankar Sharma, writing for the NIH, more and more Pharma organizations are leveraging technology to “gather ideas and feedback on trial designs, informed consent forms (ICFs), and protocols.” In other words, sponsors are encouraging trial participants to share their opinions, and are then actively updating procedures based on the feedback they receive. Of course, the FDA draft guidance on informed consent is a great resource for building effective and compliant ICFs. Just make sure you remember when you’re drafting the forms that your primary audience is patients, not scientists. Try to use clear and decipherable language, keep sentences short and to the point, and be as transparent as possible about what patients should expect in terms of potential outcomes, as well as foreseen and unforeseen risks. It’s a good idea to seek out patient feedback in advance, or on an ongoing basis, to gain insight into how to build more effective ICFs and reach a broader patient population. Making Trials More “Patient-Friendly” As Sharma points out, sponsors need to start investing time and resources into understanding the lifestyles, limitations, and/or preferences of specific patient populations, then designing study protocols with those considerations in mind. For example, appointment hours should be relatively flexible and designed in accordance with the typical schedule of the target demographic. Or if the study is centered around an age-related or degenerative condition, you may want to consider partnering with a ridesharing service to reduce the number of missed appointments due to lack of transportation. Ensuring patients can get to their appointments is important, but so is their experience once they get there. Take the necessary measures to ensure the facilities and general environment is comfortable and inviting for patients, especially for trials requiring patients to remain on-site for extended periods of time. It will have a measureable impact on retention rates. Similarly, you’ll want to ensure that the investigator site staff is properly trained not only in general customer service, but also in managing the sensitive situations and issues that can arise when dealing with a specific condition or illness. Crowdsourcing the Solution Crowdsourcing, or soliciting participation from the masses on a given issue or topic, is one potential solution that sponsors are investigating to improve trial outcomes. Major Pharma companies like AstraZeneca, Eli Lilly, and Cleveland Clinic are already experimenting with using technology and “gamification” to bolster patient participation in crowdsourcing initiatives. For example, some companies are using cutting-edge tools like Protocol Builder to host contests and solicit actionable feedback from patient communities and medical researchers alike. Some trials are extending this discussion beyond the immediate target patient population in order to gain broader insights and out-of-the-box solutions. While some have voiced concerns over the idea of opening up the discussion of complex clinical problems to the general public, there have already been some compelling examples of this idea in action. Sharma points to “Foldit,” one of the best-known examples of crowdsourcing in medical research, as her proof of concept. In this instance, a group of online gamers actually managed to “decode the molecular structure of a monomeric retroviral protease,” which had been a longstanding problem within the scientific community. The point is, the clinical research community is never going solve its problems by burying its head in the sand – instead, we should be taking advantage of all the tools and resources we have at our disposal. After all, if we want to improve trial efficiency and success rates, wouldn’t it make sense to listen to the very people who, in reality, have the most control over the outcomes?
The second installment in a four-part series on patient centricity in clinical trials – what is it and how can we be doing more to improve outcomes for patients and sponsors alike? Patient Centricity in Clinical Trials Explained (Pt. 1) provided a practical definition for patient centricity, discussed the patient mindset during the path to enrollment, and emphasized the importance of good communication and transparency throughout the entire process. Part II will focus on patient-centric trial design, which, when done properly, can improve patient enrollment and retention outcomes while simultaneously lowering costs across the board. Soliciting Patient Input When Designing Trials and Associated Materials According to Neha Shankar Sharma, writing for the NIH, more and more Pharma organizations are leveraging technology to “gather ideas and feedback on trial designs, informed consent forms (ICFs), and protocols.” In other words, sponsors are encouraging trial participants to share their opinions, and are then actively updating procedures based on the feedback they receive. Of course, the FDA draft guidance on informed consent is a great resource for building effective and compliant ICFs. Just make sure you remember when you’re drafting the forms that your primary audience is patients, not scientists. Try to use clear and decipherable language, keep sentences short and to the point, and be as transparent as possible about what patients should expect in terms of potential outcomes, as well as foreseen and unforeseen risks. It’s a good idea to seek out patient feedback in advance, or on an ongoing basis, to gain insight into how to build more effective ICFs and reach a broader patient population. Making Trials More “Patient-Friendly” As Sharma points out, sponsors need to start investing time and resources into understanding the lifestyles, limitations, and/or preferences of specific patient populations, then designing study protocols with those considerations in mind. For example, appointment hours should be relatively flexible and designed in accordance with the typical schedule of the target demographic. Or if the study is centered around an age-related or degenerative condition, you may want to consider partnering with a ridesharing service to reduce the number of missed appointments due to lack of transportation. Ensuring patients can get to their appointments is important, but so is their experience once they get there. Take the necessary measures to ensure the facilities and general environment is comfortable and inviting for patients, especially for trials requiring patients to remain on-site for extended periods of time. It will have a measureable impact on retention rates. Similarly, you’ll want to ensure that the investigator site staff is properly trained not only in general customer service, but also in managing the sensitive situations and issues that can arise when dealing with a specific condition or illness. Crowdsourcing the Solution Crowdsourcing, or soliciting participation from the masses on a given issue or topic, is one potential solution that sponsors are investigating to improve trial outcomes. Major Pharma companies like AstraZeneca, Eli Lilly, and Cleveland Clinic are already experimenting with using technology and “gamification” to bolster patient participation in crowdsourcing initiatives. For example, some companies are using cutting-edge tools like Protocol Builder to host contests and solicit actionable feedback from patient communities and medical researchers alike. Some trials are extending this discussion beyond the immediate target patient population in order to gain broader insights and out-of-the-box solutions. While some have voiced concerns over the idea of opening up the discussion of complex clinical problems to the general public, there have already been some compelling examples of this idea in action. Sharma points to “Foldit,” one of the best-known examples of crowdsourcing in medical research, as her proof of concept. In this instance, a group of online gamers actually managed to “decode the molecular structure of a monomeric retroviral protease,” which had been a longstanding problem within the scientific community. The point is, the clinical research community is never going solve its problems by burying its head in the sand – instead, we should be taking advantage of all the tools and resources we have at our disposal. After all, if we want to improve trial efficiency and success rates, wouldn’t it make sense to listen to the very people who, in reality, have the most control over the outcomes?
