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Decentralising Clinical Trials for Better Drug Formulations
Achieving Patient Data Integrity & Fulfilling Diverse Pharma Needs
Patient data is at the centre of the clinical drug development process. Data diversity is too. Drug developers and pharmacologists have always looked at collecting datasets from diverse patient groups to assess the efficacy and safety of medications in clinical trials. However, acquiring diverse patient data is exceedingly challenging due to a wide range of social and physical barriers that prove to limit trial participation. Fortunately, technical innovation, as well as general public access to the cloud, are helping pharma’s researchers raise trial participation rates, increase patient diversity and move the industry away from centralised site-based trial administration models.
Claude Price
Head of Clinical Data Management, Quanticate
Trial decentralisation trending faster post-pandemic
The pandemic significantly accelerated the decentralisation of clinical trials and saw more data being captured off-site, remotely from participants in real world settings. According to McKinsey, because health-system resources became consumed by COVID-19-related care and travel became limited by physical distancing, patients’ access to trial sites was reduced by 80%.
The impact of a pandemic on clinical trials and participation was significant. The number of trial starts monthly declined by 50% from January 2020 to April 2020, with 60% of the investigators reporting a significant reduction in trial activities by as of May 2020. This prompted drug sponsors to increasingly adopt remote consent and patient monitoring, video conference assessments, and even self-administered phlebotomies.
The concept of conducting trials where patients live significantly predates the pandemic. In an effort to overcome cost, complexity and participation issues, pharma’s developers began to innovate clinical trial design, seeking to improve every aspect of the patient experience. For example, 70% of potential participants live more than two hours from trial sites, so decentralisation broadens trial access to reach a larger number and potentially a more diverse pool of patients. McKinsey notes decentralisation can help reduce trial investigator workloads because traditional clinical site activities (drug administration, assessments and data verification) can be performed remotely by technicians or by trial the participants themselves.
Faster, cost-efficient and where the patients are
Clinical-trial sponsors continue to seek ways to help clinical trials be faster, and more costefficient while improving the experience for all stakeholders, especially patients. Decentralising clinical trials and managing their remote execution with patients using digital technologies has emerged as a critical tool in the pursuit of trial participation and patient data diversity goals. The move toward shifting clinical-trial administration to where patients are is being supported by innovation and a broad range of enabling technologies. Across the industry,
sponsors are implementing virtual trial models and hybrid models to improve clinical trial efficacy, safety and above all patient access.
The following are emerging “E” enabling technologies and are helping clinical trial designers take a decentralised approach to conduct clinical trials:
eRecruitment with artificial intelligence
Data on clinical trial recruitment reveals troublesome, systemic issues. A recent report revealed that 20% of cancer clinical trials fail because of inadequate patient recruitment. Average enrolment efficiency was also reported to be less than 40% for Phase III and IV trials. Globally, more than 80% of trials fail to enrol on time resulting in an extension of the study and/or the addition of new study sites.
Fortunately, several innovative solutions utilising artificial intelligence (AI) are emerging to help match patients to the appropriate clinical trial. AI driven information technologies can be leveraged to analyse structured and unstructured clinical data and match it to clinical trial criteria. Post analysis, makes it simpler for investigators to identify and contact potential patients for clinical trials. Platforms that integrate electronic recruitment capabilities, telemedicine with screening, consent forms and patient-reported data and outcomes, can support more efficient patient engagement, from recruitment to post-approval patient studies.
eConsent online informed digital consent
Informed consent is a critical aspect of patient rights and clinical trial ethics. Performing the entire process of consenting remotely or virtually has always been a challenge to trial
designers. Thanks to advanced information technologies, it is now possible for participants to consent from virtually any location and have that consent tied directly to their personal data. That scenario places consent firmly in compliance with 21 CRF Part 11 or GDPR requirements.
When deployed remotely, eConsent gives patients the time they need to read through and carefully consider critical trial information to make educated decisions. Today’s eConsent documents might include learning aids like hyperlinks or pop-ups with definitions of trial terminology for example. These applications are also likely to deliver multi-media content like videos or animations to help participants clearly understand what their trial experience is going to entail. The technology is beginning to demonstrate it has the potential to lower study drop-out rates because patients have the foresight to make a firm commitment to participate.
The eConsent process helps the site and other research staff administer trials more efficiently too. Because the technology is integrated with electronic data capture (EDC) systems and possibly electronic medical records and health records (EMR/EHRs) it is easier for clinical staff to track the process. It also eliminates paper-based workflows improving productivity as well as workload and staffing issues.
Collecting data directly from patients as part of patient reported outcome assessments electronically is an efficient way to improve the quality of the data collected. These electronic platforms are also integrated into EDC systems which helps site and data management teams track the completion and adherence on a real-time basis. The integration helps data flow according to the case report form (CRF) visit structure and in turn, makes the downstream data standardisation easier than integrating a thirdparty data file.
The architecture of available platforms is similar to EDC solutions—a feature that helps data managers get involved in designing and implementing the outcome assessments in compliance with regulatory expectations and protocol requirements. The user-friendly design of such tools helps patients provide accurate data without ambiguity or confusion. The Bring Your Own Device (BYOD) model is another virtual trial tool gaining popularity and a reflection of how pervasive smartphone technology is in general society. Patients, with their familiar interface and device in hand, can use them to conveniently access trial applications with ease. From a patient perspective, BYOD has real potential to increase compliance and engagement.
eSource direct data capture
Paper-based clinical processes are traditionally cumbersome and not just for sponsors and contract research organisations (CROs), but for clinical sites as well. From travel monitoring to secure record storage and beyond, a lot of time, resources, and budget end up going to things that have little to do with the actual process of collecting and managing patient and trial data.
By eliminating paper and enabling remote monitoring, direct data capture (DDC) reduces costs and resources, enabling clinicians to work more efficiently and increase trial volume. For hybrid decentralised clinical trial (DCT) models, DDC can be of real help for study coordinators in countries with less developed healthcare and telecommunications infrastructures. Because patient data must be collected remotely in these regions, DDC tools allow the collection of data offline and once connectivity is assured, it integrates the data.
For specific purposes of remote monitoring, remote source data verification (rSDV) solutions accomplish just that, remote monitoring. In an industry that is focused on cutting the cost of clinical trials, it’s no surprise that reducing the amount of time and money spent on source data verification (SDV) in studies is imperative. Once data is collected at the sites it is important to ensure it is validated and verified with the source to ensure accuracy. rSDV is not a comparison of source data against CRF data. Rather it is a review of source documentation to check source quality, review protocol compliance and ensure critical processes and source documentation is adequate. Source data verification, on the other hand, is defined as the process by which data within the report form or from other data collection systems are compared to the original source of information. Primarily, rSDV’s purpose is to verify the information transcribed in the eCRF is complete and consistent with source records. However, rSDV also helps to ensure the eCRF and source records together meet various compliance, protocol and clinical expectations.
Generally, rSDV involves specialists verifying data remotely or via a central location. However, it is feasible to have multiple sites’ source data to be checked at a central facility instead of having it parsed by individual sites. When centralised monitoring and an rSDV approach is implemented, the focus is usually on high-performing and low-compliance recruiting sites, and other locations with predicted or previous protocol deviations/violations. It is also common for centralised monitoring and rSDV to focus on data points related to primary endpoints, safety data and certain trial-related processes.
Virtual telemedicine platforms
Since the pandemic, the application of telemedicine and virtual, self-administered health care is revolutionising drug development. Virtual meeting applications on devices and laptops enable patients to connect with their clinical trial sites from virtually anywhere in the world. These applications make it possible for clinical trial research to progress in an environment even if locked down. Many of these solutions provide real-time video capabilities and can take consent from patients in their own language. These technologies are a perfect way to connect patients, site coordinators and investigators while avoiding the time and cost of onsite clinical visits. Depending on the circumstances virtual clinical trial administration via telemedicine is likely to be the safest, most convenient way to deliver the trial to patients virtually.
AUTHOR BIO Conclusion: It is all about the patient
CLAUDE PRICE has 18+ years of experience in clinical research, covering roles in both Clinical Data Management (CDM) and Project Management. A majority of his time has been spent in CDM at both large and small CROs. Claude has been responsible for overseeing large portfolios and managing Data Management groups, whilst working across numerous therapeutic areas and study phasess. Patient centricity is a key aspect to consider in the clinical development process. When we gain an understanding of what the patient really wants and needs and then incorporate that into the expected outcomes of the treatment, we are truly becoming patient centred.
With COVID-19 in the rear-view mirror, governments and healthcare systems are working diligently to keep patients and research safe by adopting decentralised virtual trial delivery options. This approach also provides more comfort and convenience to patients. It’s a new normal for the whole world and enabling patients to participate in clinical trials wherever they are located, should be the focus going forward. Patient data and data diversity are critical to better medicines and virtual trials enabled by technology are delivering the solutions pharma needs to be more patient-centric.
