infocusapril22

The phrase “patient-centricity” has been circulating the healthcare and clinical research industry for quite a while. What does patient-centricity really mean and how can we ensure our practices are meeting and exceeding that definition?   The March Sites NOW meeting tackled all things patient-centricity and discussed practices industry can implement now to impact study success.  Improving Study Design from Start to Finish  In a Sites NOW poll, 49% of respondents said they currently have patient-centricity policies and procedures in place, while 30% have procedures in development, and 21% don’t have any patient-centric procedures in the works. Patricia Roselle, Sanofi, stated that before you consider exploring any patient-centric processes, keep in mind the strategy should span all the way from pre-trial to post-launch. It’s an ongoing process that involves conducting surveys throughout the study, asking open-ended questions about patients’ research experiences, and following up every six months with surveys.   Getting feedback at the end of a study is too late – if there are trends across sites, protocol amendments should be considered. We can’t assume things are still working well – we need to get feedback continuously.  Learning throughout the trial and acting as quickly as possible to implement any needed changes will have a massive impact on patient retention.    Health authorities and industry are experiencing a learning curve to understand how science can be fused with patient insights for better integration. Traditionally, sponsors have known the simplest way to implement patient-centered initiatives is to start at the study design phase to reduce burden.  When looking at study design, consider how it impacts Diversity, Equity and Inclusion (DEI) efforts. Some long-standing inclusion and exclusion criteria are inherently biased and severely limit potential participants. Address this by ensuring protocols are easier for patients to qualify for participation in studies. Although protocol amendments can be a pain point, they are incredibly important when they impact who can be included in a study.  The patient experience can also be improved by reducing patient/caregiver inconveniences through means such as providing transportation, reimbursement, and home health care options.  As part of industry’s collective efforts to make clinical research more understandable and approachable to the general public, we need to keep in mind that patients are people. How do they feel about the term “patients”? Industry can create more comfort by asking patients how they want to be referenced.  Creating patient-centric practices is usually a budget issue, so industry partners need to walk the walk and support it in every way on a project basis. If CROs are unable to allocate additional funding for a particular study, keep it top of mind for future studies.  Patient Champions  Patients, sites, CROs, sponsors and vendors all need to be a part of the conversation in order to make patient-centricity a reality. This means all stakeholders need frequent site and patient feedback to better understand patient experiences. It’s not something only one arm of clinical research can tackle, as Sites NOW panelist Ellen Price mentioned. “Without collaborating with sponsors and CROs, we wouldn’t be able to bring these patient-focused plans to fruition.”   Sites, find your like-minded, patient-centric champion who shares your values and can have conversations around patient engagement programs. Ask your CRO partner to connect you with the right person who will be your partner/advocate and communicate patient needs and feedback to enact change. Be persistent! CROs value hearing from sites and may not get to speak to them often, so your input is important.  What is our industry missing with patient centricity and how can we help change?  After the presentation, Sites NOW attendees divided into groups for further discussion to share thoughts on what industry is missing with patient-centricity.   One insight is that not everyone wants to do things the same way, so flexibility and options for patients are important. Additionally, industry tends to group patients in specific therapeutic areas together and generalize their needs without considering individual patient barriers. We need to understand the patient before writing a protocol.  Listen to sites in the early stages of protocol development for input on what may or may not work. Site Advocacy Groups are a great tool for this. Also, industry needs to consider how sites will manage flexibility options operationally.  The conversation was mixed in regards to finding a balance with technology use in trials. We’re adding many new technologies to studies, but are they all patient-centric? Technology can add a lot of stress on study coordinators to manage, where 30% to 40% of their time is spent at the computer dealing with technology. Tech support services are needed to remove this burden from sites. Consider what can we offer through telehealth and other virtual means to assist patients with accessibility, keeping in mind simplicity is the key for both sites and patients. As the industry looks to implement more patient-centric approaches, we also need to consider how to provide meaningful support and services to patients without adding burden to sites.  If you want a glimpse of what participants experience in your trials, “Volunteer to be a research participant yourself to experience the process.”  The full meeting recording featuring Patricia Roselle from Sanofi, Lisa Dyment of PPD and Ellen Price of Meridian Clinical Research is available to view here. 

By Kelly McKee, VP Patient Recruitment and Registries, Medidata New medicines and vaccines are made possible through the participation of clinical trial volunteers who provide data to sponsors and research teams as part of the drug approval process.  Traditionally, sponsors and CROs have relied on clinical trial sites to ensure that participants have positive clinical trial experiences and have spent little time designing or optimizing experiences from the perspective of a patient. If we are to make meaningful change in access, inclusion, and equity in clinical trials, the patient experience must improve. Historically, patient participation and engagement have been limited to study visits and entirely confined to site and patient interactions.  Technological innovations and the emergence of Decentralized Clinical Trials (DCTs) have brought some of these interactions from outside the study site and into patient’s homes through innovations such as electronic informed consent (e-Consent), electronic patient-reported outcomes (ePRO), diaries (eCOA), live video visits, and sensors. Too often, these technologies are implemented singularly, with little or no regard to the holistic experience needs of the patient.  Engaging Patients Pre-Trial Not all patients are prepared to participate at FSR (First Site Ready).  Clinical trial participants are people and making the informed decision to participate can be a complex and emotional process.  Patients need time to become educated on clinical trials, and to feel engaged and empowered to choose clinical trials as an option. By engaging patients early through pre-trial registries, sponsors and CROs can provide information to help patients make the right choice for the right trial at the right time. Additionally, patients can be asked to provide their preferences on trial experience via surveys and registry data capture to help design more patient-centered trials.  Engaging Patients Post-Trial Clinical trial participation may end with LPLV (Last Patient Last Visit), but expecting that a patient doesn’t need to be engaged beyond their last visit is short-sighted.  With the vast majority of patients (95%1) being willing to participate in another study, providing additional opportunities to patients just makes sense.  Historically, data provided by clinical trial participants has not been shared with these individuals or their healthcare teams when their participation has come to a close.  In the 2017 Transcelerate survey, “What do Clinical Trial Participants Want?” a clear majority of respondents favored patient data return with 81%2 and 83%2 requesting data return during and after a trial, respectively.  It is incumbent upon us to make it easy for sponsors to return data to patients and easy for patients to receive this data.   Why is a Unified Platform Experience Important? As DCTs continue to gain popularity, the industry has been inundated with point solutions for each step of the clinical trial process. This has resulted in a disjointed and chaotic experience for sponsors, sites and patients having to use multiple systems and portals for a single study. A unified solution is needed to bridge the gaps between data and workflows so that patient data is entered only once and automatically drives downstream workflows such as randomization and dosing calculations. Additionally, a single destination patient portal enables patients to engage in all of their clinical trial activities with one login. This unified experience not only gives patients continuous support in and out of a trial, but improves experiences and retention.  At Medidata, we believe that the right combination of tools, people, and processes can create better patient experiences while enabling sponsors and CROs to execute faster, smarter trials driven by high-quality data. References: CISCRP. (2021). Perceptions and Insights Study: Participation Experience. https://www.ciscrp.org/. Retrieved April 1, 2022, from https://www.ciscrp.org/wp-content/uploads/2021/11/2021-PI-Participation-Experience-Report-04NOV2021-FINAL.pdf TransCelerate BioPharma Inc. (2017). What Do Patients Want? https://www.transceleratebiopharmainc.com/. Retrieved April 1, 2022, from https://transceleratebiopharmainc.com/wp-content/uploads/2017/11/What-do-Patients-Want-Visualization.pdf

By Alexandra Charge,Practice Lead, Clinical Solutions, Real Chemistry Eva Kaczykowski, Director, Digital & Social Media, Real Chemistry “Trial Participation is Most Frequently a Result of Physician Referrals.” This is a fact often quoted in industry research, with the expectation that treating physicians and community healthcare providers (HCPs) should be the binding glue in patient engagement and inclusion in trials. Therefore, connecting with them directly to raise awareness about trial options available for their patients, can close the gap in the equation. The evidence suggests there is a keenness to refer, but the challenge of how – how to learn about and access trial information, how to talk about trial options, and how to refer – is a constant barrier. However, a lack of access to clear information should not be an issue in our digital world. Digital Transformation Pre-pandemic, the digitalization of healthcare was well underway, however in the years since, there has been a marked increase in uptake of digital channels and strategies for disseminating information. Healthcare is more digitalized, accessible, and connected than ever before. Reaching a wider network of people, coupled with the eventual uptake of decentralized clinical trials by the industry from pilots to near normalized, may at last provide the right combination in engaging, and enabling, all the stakeholders needed for clinical trial recruitment success. Facts & Figures In 2020, doctors increased their sharing of medical information on Twitter by 26% YOY resulting in greater access to scientific information by consumers. Pre-COVID, only 18% of UK Family Medicine/General Practice specialists said they held online meetings with colleagues, whereas 56% have begun holding online meetings with colleagues since COVID. EU-based oncologists & hematologists are active social users, with 42% going online 8+ times per day for professional purposes.    A record number of around 1,300 trials with a decentralised and/or virtual component will likely initiate in 2022, representing a 28% increase from 2021. A recent McKinsey survey with leaders across the life science industry shows an expectation that overall decentralization levels will reach ~60% across all activities within the next 5 years. The Challenge There remains a marked gap but an ever-growing need for engaging closer with the wider network of HCPs in the paradigm of clinical trial recruitment. This could enable a connection to more patients, better understand patients’ needs in their everyday life and “community” and widen representation and inclusion for trial recruitment through the physicians as “trusted voices” for patients. The ways in which clinical trial awareness resources can be distributed digitally are distinctly different internationally (country by country) to those in the US, due to different rules on patient and HCP engagement at local levels. In addition, direct-to-patient communication on social media and digital channels has recently been further impacted by privacy changes affecting targeting capabilities. In any case, a patient receiving an ad via social media with a link to a trial website without context, cannot transfer the importance or relevance of a trial without an accompanying conversation with their doctor to better understand trial requirements and any concerns. This is even more so the case when considering a highly unmet need in rare diseases, or a time-dependent therapeutic area such as oncology, where the necessity to expedite the time in decision making is critical. Connecting in parallel with both the HCP and the patient and caregiver in raising awareness about a trial as a treatment option, will help have a more cohesive discussion when both are equally aware and versed on the trial options, challenges and expectations and enable a co-educated partnered discussion if a referral is suitable. The trick here to make it viable is removal of burden on the HCP community, to help inspire more HCPs to believe in research, and motivate them to have conversations about clinical trials with their patients. The initial burdens could be multifold, and the list below is only some, among many others: discovering trial options in the first place, understanding the complexity and eligibility which could impact patients, determining what the key discussion points should be with the patient about current treatments vs an investigational drug, and finally, there is a powerful opportunity for innovative but investigational drug access, but this leads to the burden in the risk/benefit determination. Importantly, with an increase in the volume of potential referrals, there is a need for reduction in burden on the PI and clinical trial site staff. But through well-designed, informed, collaborative HCP referrals, the quality of the patient referrals, in parallel to the higher volume of engaged patients, becomes a reality. With a reduction in burden, also must come an understanding of benefit. Sponsors need to take the time to discover what the drivers and barriers may be for HCPs to refer their patients, as each patient population, each investigational drug, each trial design, and each trial landscape & timeframe is different. The solution falls to bringing the right information to the HCPs in the overall treating medical network, enabling them with knowledge through insightful targeted communications, simplifying the evaluation and decision making, and arming them with patient-centric materials and resources. All to help engage easily in a conversation with the patient about all options, while easily connecting with the right resources to compliantly refer to for more detailed questions about the trial. This can only be achieved successfully through our digital and interconnected capabilities. Connecting with physicians on social and digital media channels that they are already active on, and importantly trust, in their personal, educational and professional daily life, is important to purposely and effectively interact with busy individuals. Providing valuable information in an efficient and concise manner is the key to disseminating specialty-specific knowledge about the trial if healthcare providers are to play an essential role in advising, guiding, and supporting patient participation in clinical research. The How Define: In order to best activate a digital HCP referral campaign, we must begin by defining the vision and objectives for the approach. In clinical trial recruitment, we know the ultimate goal is timely patient accrual through successful randomizations, and in this context, from an increase in relevant patient referrals. For a digital campaign this must be translated into achievable and measurable metrics: consider the audience journey and the end goal. This could be pre-screener completions on a trial website, or confirmations via a referral survey to understand how and where successful patient referrals have come from. Discover: Next, it is important to discover relevant insights and data about our key audiences. First, by understanding a patients’ medical, and emotional journeys, to determine the key touchpoints with the various HCPs and their varying influence through their interactions, and then by looking at the physician journeys and behavior to harness a deep understanding of their profiles, including digital behaviors and activity. It is vital to take the time to research on a per specialty and country basis; a one-size-fits-all approach derived from the US landscape cannot be applied globally as each region and each HCP specialty practicing within each country has a unique experience that needs to be understood. Design: The learnings found through audience analysis will then enable the design of a robust campaign via digital channels that HCPs are already learning and connecting on. A multichannel approach (e.g social media, HCP closed networks, paid search) is generally recommended in order to reach the target audience at an increased number of touchpoints, and therefore increase likelihood of message recollection as well as improving the chance of reaching a higher number of HCPs. The onward journey for interested HCPs, to find out more from these digital channels, must be easy; an intuitive and smooth user experience, driving to a trial Knowledge Hub of robust, succinct information via a central website for HCP awareness and learning. Develop: A strong audience, or user journey, can only be effective if driven by the development of clear campaign messaging, materials, and meaningful discussion resources for HCPs to share with their patient community, which are founded in the campaign & business objectives identified at the Define stage. As well as increasing campaign success by effectively engaging physicians, this will widen the inclusion potential as it equips these physicians to become the trusted patient partners in supporting a difficult decision. Deploy & Dissect: Next is the deployment of the campaign, which comes hand in hand with dissecting the campaign, aka analysis, as one of the benefits of digital activation is the real-time learning and optimization of the approach to drive efficiencies and better results. For example, if you are seeing that a certain message or channel is delivering more traffic to your trial website, you can look to redistribute investment to boost the likelihood of referral. Summary A systematic, data-driven process exists to understand the sophisticated nature of the healthcare professionals’ digital communication requirements and potential for successful utilization in clinical trial referrals. This, through the digital and social marketing capabilities combined with the compliance and clinical expertise required to formulate the trial messaging of interest, could be a powerful modern interpretation of the classical “Letter to Colleagues” to drive referrals. The trust-relationship of peer-to-peer interactions has taken a new step forward in online HCP community engagements hence the utilization of these growing social and membership-based channels, needs to be understood and engaged with in the new post-covid digital environment. Through a geographically wide reach enabled by digital and social media, the ability to increase representation of patients can be achieved, and finally democratize access to trials – for patients, and the wide medical community supporting them. A Case Study: Digital HCP Outreach and Referral Campaign for a rare form of cancer The Real Chemistry team worked with a sponsor company on a digital HCP outreach and awareness campaign for increasing referrals for a rare cancer trial. The campaign was successful by generating lots of interest via HCP activity which resulted in more than 660 unique website visits. Due to this success, the caregiver and patient campaign was initiated in parallel, with the knowledge that HCPs along the treatment journey have already seen relevant messaging and will be equipped to answer patient questions about the trial effectively.