There’s a lot of talk about patient centricity in the clinical trial arena these days, and for good reason — hearing the voice of the patient and incorporating patient perspectives into trial design can bring huge benefits to all stakeholders involved. But what does it mean to be patient centric? What tactics are leading pharma companies utilizing to ensure centricity in their trials?
Clinical research is undergoing a metamorphosis by focusing on personalized medicine and patient empowerment. During more than 10 years patient centricity and patient engagement are the buzz words in clinical research, although recent articles still show that :
- Up to 80% of clinical trials fail to meet recruitment targets.
- +/_ 30% of participants drop out of clinical trials.
- only 39% of sites achieve their enrolment targets,
- 11% of sites fail to enroll even one single patient into a trials.
- Study timelines are frequently doubled beyond their planned enrolment.
Are we ready answer the unmet needs of these patients in trial participation ,trial design and execution at best ?
Reason for participating
Various studies are revealing that the most important reason for participating in a clinical trial is varying between patients. Personal gain (access to new treatments), financial benefit (reward or absence of payment for drugs), altruism (the belief to help other patients / for the welfare of others), communication (exchange of information, language, knowledge, understanding and misconception). Having a lack of information, along with a lack of understanding of clinical trials and concerns on the effectiveness of clinical trials results in non-participation.
Especially with the arrival of the new age e-patients, the patient as self-manager of their own disease, being better informed and willing to be empowered; has changed the expectations and quality of discussions between the physician and patient. New age patients are demanding more information about trial conditions and results; although Clinical Research teams still feel concerned to open complex clinical info to patient groups based on privacy Issues . Although, having more info and data transparency can help building trust and confidence in patients participating.
When big data analysis has identified patient groups, social media can help spreading clinical information to a wide network of patients (from recruitment to retention). Remarkably or not, patients do not necessarily respond as expected to generic promotional posts if no individual core message is present. To be successful, these posts should reflect the idea of patient centricity and engage, inform and focus on their individual needs. One size doesn’t fit all. Do we know which formats our patients prefer? Print? Text? Mobile apps? How often do they expect updates? Do we use patient segmentation in selecting the required format and timing? One size doesn’t fit all once more.
As communication & understanding are crucial to participation and retention, spending more time with patients upfront is the only way to learn about unmet medical needs and to uncover concerns and motivations unique to your trial design before amendments are needed. Involving patients in trial design before trial & protocol design might be the best patient recruitment plan. Engaging patients and advocates in the viewing of protocols, endpoints, and the informed consent process for specific programs would be a perfect KPI in protocol design.
Crucial is that the clinical investigator (as crucial motivator for participation) or the research team are spending enough time to explain trial documents at start. As it will enhance trust and acceptancy with patients.
If we are using Big data to identify and digital channels to reach out to patients, how often do we hear how complex, difficult our study documents are? Before we identify and then transfer, let us make the reflection of what we want to share.
Once a patient is enrolled, they may need additional support, especially if the study is long. Support by reminders as e-diary completion, smart medication delivery, medication and study visits, trials @ home , real world data collection and exchange can be enhanced by new technology and wearables. Designing patient friendly visit schedules when patients are dependent on caregivers, would be beneficial. Attention should be given to provide facilities and a pleasant environment to patients, especially during prolonged on-site visits, or visits that require patients to be in a fasted state. Trials @ home can be applied to specific patient groups or needs. The use of social listening techniques review what patients are discussing online regarding disease state and site issues can drive better patient participation and relationships. Being sensitive to the patient’s comfort and needs is not a mode of action, it is a mindset reflected in retention rates. From hospital to hospitality.
Moving to EDC systems is a huge and surely not the last step forward. But how will we integrate this data and what do we want to do with the insights? How do we translate this into patient centered solutions engaging and empowering our patients ? The paradigm shift is still from data collection by new technology and wearables to the widespread access towards patients and caregivers. Changing business culture, personal mindset at all endpoints will be crucial for patient engagement, more so than new technology.
Building strong relationships with trusted clinicians, patient organizations to create referral and advocacy programs for and with patients eligible for new clinical trials are not driven by technology transfer but by insights and belief. Partnering with the new e-patient is at one hand challenging but at the other hand an immense source of joy. Engagement is mostly based on respect, on sharing information, on reaching mutually agreed outcomes between well trained & experienced teams hand in hand with the newest technology and patients. Partnering with patients and communities will allow study managers to tailor their approach so it works for different patient groups and physicians, to increase patient enrolment and long-term retention.
As the focus on healthcare and its access to patients increases, it calls for adaptation. The future seems to be bright, we have the potential to work symbiotically, a Co Creation between all partners involved as guarantee for involvement, to a most pleasant journey from working for to working with patients. Findings are based on literature search, webinars, forums and congress data and mainly gathered directly – easily and by listening to echo’s in the field .