ICON, a healthcare intelligence and clinical research organisation, recently released its ICON Cares 2022 Environmental, Social and Governance (ESG) Report. Diarmaid Cunningham, Chief Administrative Officer at ICON, shares insight with DDW.
At ICON, we engage with our key stakeholders through a variety of methods and the environmental, social and governance (ESG) report is a key element of this engagement. Our ESG reports are designed to provide an overview of our ESG priorities and commitments, summarise our current policies in respect to ESG matters and provide an update on our actions and results during the year. The data we collect is under continual review and we take it into account for strategising and adjusting our goals and activities as appropriate.
We continue to take important steps to embed our ESG priorities into the core of our business. Throughout this journey, we have consistently taken several important steps.
Our ESG priorities have been identified through a comprehensive materiality assessment. We continue to review these priorities focusing on the areas where we can have the greatest impact. Six of our seven priorities are social in nature: access to clinical trials, clinical trial ethics and conduct, advancing public health, improving the ICON employee experience, talent management and increasing diversity both internally and in clinical trials. The final significant priority is environmental climate change, greenhouse gas emissions and energy use.
Diversity and inclusion
One of ICON’s key ambitions is to make it easier for patients, across all dimensions of diversity, to participate in clinical research. Developing drugs with maximum effectiveness for the broadest group of people requires comprehensive patient representation in clinical trials. Without data across the spectrum of race, ethnicity, sex, gender, age, and genetics, to name just a few traits, it is impossible to fully understand how novel therapies will affect specific populations, or if any demographic may incur additional risks.
ICON’s patient centric philosophy includes a multipronged approach designed to increase diversity among participants and everyone involved with our clinical trials. Elements that are included in this are:
Building trust: To start, we build trust with underserved patient communities by diversifying the make-up of our Accellacare Site Network clinical site staff. We host local events and offer free health services. We partner with community-based institutions to build our credibility and engage key influencers in specific communities as important research partners. With other partner sites, we employ several actions to set enrolment expectations that are demographically appropriate to each site, and we tailor our support to each site’s needs to help reach their unique demographic goals. We also provide training on implicit bias and other cultural competencies and make adjustments at our sites to their working practice if needed to accommodate the target demographic populations.
Simplifying participation: We simplify participation using services such as digital health technologies and in-home visits to make it easier for people to participate in clinical trials. We recommend a critical evaluation of the protocol to ensure it is challenged for broad inclusion. We also proactively reduce the logistical and financial burdens of trial participation. This may include helping parents or guardians get compensated for earnings lost from caring for a child who participates in a clinical trial.
Spreading the word: When recruiting, we focus our conversations with sites on how they plan to recruit for their unique demography and ensure we can provide the tools they need. We drive outreach activity by developing awareness campaigns across different advertising platforms.
Patient feedback: We factor patient feedback into the development of recruitment materials, which feature plain language and use images and messaging reflective of underrepresented populations. We recognise that education must be done within sites to ensure all staff understand the context and case for diversity of each trial and have unique materials to help orient patients who may be new to clinical research. Materials may include items such as “What is a clinical trial?” videos, Informed Consent summary guides and other tailored patient-facing supports.
Refining our approach: We refine our approach using real world data to evaluate diverse patient population samples at or near sites. We also host paid focus groups, led by diverse persons, to enhance our understanding of unique barriers to clinical trial participation faced by the targeted demographic. We continually seek feedback on any procedures and criteria that may hinder enrolment for any given subgroup.
We aim to be good stewards of the natural environment by managing and reducing our greenhouse gas (GHG) emissions and energy use.
With regards to electricity consumption specifically, in our move toward renewable energy, we have transitioned 12 locations to green power, and 61.7% of our electricity consumption in 2022 came from renewables, with 15% being sourced through direct tariffs and 46.7% purchased through renewable energy credits (RECs).
Overall, in terms of operating our business more sustainably, in addition to reducing our energy consumption, we are focused on the following:
Carbon emissions: We have committed to the Science Based Targets initiative (SBTi) and will set GHG reduction targets. We apply the GHG Protocol Corporate Standard to calculate carbon emissions and our Scope 1 & 2 emissions are verified annually by Carbon Trust.
Ensuring sustainability of our offices: Our real estate team factor in environmental considerations when selecting new locations for offices and planning building modifications. We’ve consolidated office locations to align with new working styles and business needs.
Access to clinical trials
Decentralised and hybrid clinical trials based on digital technologies and remote patient management continue to gain traction, bringing a range of benefits to patients, sites and sponsors. DCTs are delivering benefits for sponsors in a number of ways – delivering quality data quicker to reducing time to market, achieving higher levels of compliance, increasing diversity of patients participating in trials, and importantly, increasing patient retention.
Encouragingly, there has been significant progress in decentralised and hybrid clinical trials in the last few years, with the global Covid-19 pandemic serving as a catalyst that brought major shifts in how we approach the execution of clinical trials. Although the recent uptake has been considerable, decentralised clinical trial components have been successfully implemented and ongoing for quite some time, and we have seen different phases and scales of adoption across the board. More organisations are rolling out pilot programs, implementing hybrid trials more extensively and overall delving deeper into decentralisation to explore the benefits it offers. However, a decentralised clinical trial approach is not appropriate for all studies, therefore we expect there will be a need for the traditional trial model also into the future.
At this point in the shift to decentralised studies, we are getting valuable real-world experience to drive continuous improvement. Sponsors now have a clearer view of critical success factors such as early planning to ensure optimal engagement with patients and sites, selecting the right in-home clinical services, wearables or sensors, and staying close to the patient throughout the study.
Getting these essentials right can be transformative, as illustrated by CHIEF-HF, a decentralised study of canagliflozin in heart failure. It achieved around 98% protocol compliance, using electronic patient-reported outcomes (ePRO) and eDiary technologies.
Through the execution of this trial, and indeed others, we have learned a number of lessons, including:
- Service options: Selection of these, such as in-home visits, should be closely managed. In order to do this, for each trial, a dedicated team at ICON, comprising subject-matter experts with long experience in the industry, traces the whole patient journey through the trial and makes recommendations on service elements, based on their own therapeutic expertise and parameters such as study outcomes.
- Sight of patients in the home setting: By increasing touchpoints with trial participants, sponsors can make sure patients are filling out their eDiaries or generating ePROs on a scheduled basis. With a central team monitoring these inputs digitally behind the scenes, sponsors can identify and address any compliance issues sooner rather than later.
- Selecting the right devices: The sheer range of possibilities can make this challenging. ICON has a team dedicated to ensuring, for example, that the right device is selected, and that the patient is supported for compliance. Study objectives will feed into these considerations. Device selection also depends on the therapeutic area involved, study duration, endpoints, patient-burden assessments, and whether it involves passive monitoring or active assessment. Patient centricity and device useability are paramount, as are device characteristics such as battery life and connectivity. Sponsors also need to think about device validation, data transfer, storage and visualisation, and regulatory issues such as privacy and security.
- Defining core roles: It’s beneficial to define and maintain a focus on core roles, whether in the site team (e.g. clinical insights) or the concierge service (vendor management). CROs, for example, perform a range of different roles. Sometimes it may be difficult for sites to know who they should be talking to. Clarifying those roles clearly in advance also gives sites and physicians confidence that the team has experience in overseeing patients virtually, and that any issues arising from interactions between, for example, patients and concierge services, will be escalated and conveyed promptly to sites.
- The value of real-time support during the trial: Virtual coordination centres or concierge services are hugely important. These resources help with scheduling, welcoming patients, managing consent, responding to patient concerns and collecting reported events. They can also ease the transition to decentralisation for trial sites.
These above elements are all important in ensuring the benefits that decentralised and hybrid trials can be fully realised by the sponsor.