Business Process Services White Paper Reimagining the Clinical s Process through Digital Disruption
About the Author Reema Deb Reema has been working with Tata Consultancy Services (TCS) since 2013 in the niche domain of clinical data management. She started her career in marketing and then moved to scienti c content writing. Driven by her interest in clinical research, she pursued a post-graduation diploma in the subject. She has a Bachelor's degree in Biotechnology and a Master's degree in Microbiology from Bangalore University.
Abstract Clinical research organizations face mounting challenges with conventional clinical trial processes due to rising costs and complex regulations. Difficulty in recruiting subjects for trials and ineffective measures to monitor the trial process add to these challenges. Also, the lack of effective data management and reporting tools impedes effective management of large volumes of patient data for regulatory purposes. These challenges have led to time lags, operational inaccuracies, and constant re-work for the healthcare teams. In this context, digitization is seen as a potential solution to tackle these challenges and to bring about the much needed process improvements. This paper discusses how digitization can help transform the clinical research industry from relying on manual processes to one that drives its processes and data through technologies that aid centralization. Digitization drives faster time-to-market as a result of automation, real-time ow of information, de-risking of processes, and enhanced coordination between stakeholders.
Contents Challenges in the Clinical s Industry 5 Ineffective monitoring 5 Poor quality control measures 5 Absence of effective data management and reporting tools 5 Difficulty in recruiting patients and identifying sites for trials 6 Driving Process Improvements through Digitization 6 Building a centralized control mechanism 7 Leveraging a cloud-based platform 7 Improving quality control 8 Effectively managing data through digitization 8 Streamlining data collection 8 Facilitating cross-linking of trials 8 Generating automated reports 8 Ensuring smooth regulatory compliance 9 Unlocking Further Potential: Getting More out of Digitization 9 Accelerating recruitment of subjects 9 Tapping into telemedicine for better access 9 Harnessing Big Data and analytics to improve study design 10 Speeding up the Process and Improving Efficacy of Clinical s 10
Challenges in the Clinical s Industry Most clinical trials firms face challenges due to the nature and scale of their operations and the complex regulatory framework. In addition, even before the trials begin, site selection and recruitment of personnel can be bottlenecks, significantly increasing the time-to-market. Moreover, to ensure data coherence and compliance with clinical trial protocol, adequate monitoring is required, which in turn leads to the need for large budgets. Conventional clinical trial processes (see Figure 1) require significant time and resources to be invested for data cleaning, monitoring, and reporting to the concerned regulatory authorities. There is a potential risk of human error, as well as additional cost overheads, while executing these processes. Ineffective monitoring Conventional clinical trial processes with decentralized systems require extensive monitoring. Ineffective monitoring can lead to time lags between data gathering and analysis, which can adversely impact profitability. It also increases the likelihood of non-compliance with protocols and regulatory requirements. This could result in re-work or re-initiation of systems, further delaying new product launches. Poor quality control measures Data management in traditional trials requires human intervention at every stage. A conventional clinical trial setup uses unsystematic data collection methods, and it lacks the support of technology-enabled quality control measures, resulting in a higher rate of errors and protocol violations. Absence of effective data management and reporting tools Traditional paper-based methods of data collection and archiving result in significant cost overheads. Quick retrieval of data from reports also becomes a challenge for project teams. This results in submissions that are non-compliant with regulatory standards. 5
Center-2 Center-1 Center-5 1) Large teams of highly-skilled professionals 2) Extensive monitoring mechanism 3) Risks associated with time lag Center-3 Internal Reporting Regulatory Reporting Center-4 Monitoring body for ensuring protocol and regulatory compliance 1) Data submission for reporting purposes only 2) Non real-time submission 3) Time lag Large and decentralized teams 1) Large teams for data processing and reporting 2) High level of human intervention 3) Increased human errors 4) Reporting time lags and delays Figure 1: Conventional method of conducting clinical trials Difficulty in recruiting patients and identifying sites for trials Recruiting subjects and enlisting sites are major challenges in a clinical trial. To conduct an accurate and successful clinical trial, it is imperative that the sponsor selects a site where the disease is most prevalent. This can be done by analyzing internal databases which contain extensive information based on past experience with sites. Recruiting eligible patients is the next step. Patients are selected based on the inclusion and exclusion criteria mentioned in the pre-defined protocol. For example, the oncology trial protocol states that a subject participating in the trial should not have undergone any chemotherapy or radiotherapy treatment one month prior to participating in the trial. However, during screening, subjects sometimes do not mention their recent chemotherapy treatments, thus adversely affecting the trial outcome. Rigorous patient screening is therefore crucial for ensuring accuracy of clinical trials' results. Driving Process Improvements through Digitization Sponsors face issues such as expiring patents and shrinking product pipelines. To overcome such challenges in a rapidly-changing economic climate, it is important to reinvent the existing approach to 6
clinical trials. Digitization helps accelerate the regulatory approval process, which leads to a reduction in the cost of drug development. Figure 2 shows a schematic representation of digitization of conventional clinical trial process. Center-1 Center-5 Center-2 Real-time data movement Data submission for quality control, compliance testing, and reporting Central team for quality control, monitoring, compliance, and reporting (internal and regulatory reporting) Center-3 Center-4 Lean teams Centralized control mechanism System driven checks Protocol, regulatory requirements, and criteria built into the system Automated processes and report generation Easy data handling Low human intervention ensuring high quality control Better collaboration among various stakeholders Figure 2: Reinventing the conventional clinical trial process with digitization The clinical trials industry can implement digitization in the following areas. Building a centralized control mechanism A digital archive of trial patient records in a central repository helps monitor and control data in real time. It also improves coordination among stakeholders across locations. This significantly reduces errors and monitoring cost, and enables de-risking of processes and acceleration of time-to-market. Leveraging a cloud-based platform All platforms used by various stakeholders in the clinical trials process can be integrated with a cloudbased platform that enables advanced analytics and algorithms. Based on the results derived from the analytics and algorithms, the organizations can assess the risk associated with the process. In addition, the study team can monitor the methods followed by the sponsor to recruit subjects, and other important parameters such as accuracy of the products used for investigation. With the application of predictive analytics on trial data, serious adverse events can be proactively managed. Also, sponsors can use the centralized digital platform to report an adverse event, which alerts other stakeholders in real-time, providing them an opportunity to make course corrections. 7
Improving quality control A digital platform enables structured data capture. The platform captures the exclusion and inclusion criteria defined by the protocol, including regulatory data requirements. It enables tracking of data and flagging of inconsistencies, thereby significantly reducing the need for human intervention to ensure data quality. Effectively managing data through digitization A centralized, digitized platform can be used to effectively manage data and to reduce errors. For example, the clinical trial data can be assimilated into a digitized tool, and automated quality checks can be run on the data on a regular basis. By implementing these checks in the clinical trial, the relevant stakeholders can assess and monitor the performance of a site, the number of subjects enrolled in the trial, and any protocol deviations. Streamlining data collection Most clinical trials are conducted at a global level, resulting in massive data generation, collection, and management. Leveraging a digital platform enables sponsors to manage the huge volumes of data in a systematic, structured, and meaningful way. Implementing an Electronic Data Capture (EDC) system helps streamline and index data in an efficient and scalable manner. Moreover, it promotes faster retrieval of data and faster processing of voluminous data to generate meaningful reports. Facilitating cross-linking of trials Individual clinical trial teams collect and manage data in silos within an organization, unnecessarily reinventing the wheel with every development program. A digital platform enables the use of data across trials and locations, resulting in efficient use of time and resources. For instance, two different trials could be carried out on the same drug by a certain company, resulting in different indications. If one study team discovers that the drug affects the cardiovascular system of the subjects, it is important that the other team also be aware of it, so suitable tweaks can be made in their approach. Generating automated reports Digitization not only enables automation of periodic report generation, it also allows faster generation of ad-hoc reports for timely decision-making. At the end of the trial process, clinical data management personnel are required to verify and upload all data. Typically, the team manually checks all the forms and data, in addition to verifying and reporting the source in a case report form (CRF). With digitization, data management personnel will be able to easily schedule the generation of reports, and ensure they are sent to the study managers. 8
Ensuring smooth regulatory compliance The consequences of non-compliance are complex and significant. Digitization of clinical trials strengthens the regulatory framework by supporting data and reporting requirements. Low levels of human intervention, system driven checks, and meaningful storage of information ensure data accessibility and quality. Automated reports ensure accurate reporting and timely delivery to regulatory authorities, and the reports can be made compatible with regulatory submission format requirements. Pharmaceutical companies need to ensure that they are compliant with the requirements of 21 CFR Part 11 while implementing digitization initiatives including e-signatures. Unlocking Further Potential: Getting More out of Digitization In addition to enabling process improvements, digitization can help in other areas of clinical trials such as recruitment of subjects, telemedicine, and analytics. Accelerating recruitment of subjects Many companies are successfully recruiting patients through social networking and mobile platforms. Moreover, with slight adaptations in study design, sponsors can conduct virtual trials and subjects can provide data through text messages using mobile devices. This process enables real-time monitoring and helps collect large amounts of data conveniently. This type of approach can be adopted in observational trials or in phase IV trials. Digital signatures are also being used in clinical document management and exchange. The process standardizes paperless automation across various phases of clinical trials. This can lead to improved operational efficiency. Electronic Health Records (EHR) help reduce the cost of clinical trials, especially for recruitment of patients. Researchers should be able to find suitable candidates by merely entering search criteria into the system. The patients would then be screened digitally to determine their eligibility based on trial-specific criteria. Tapping into telemedicine for better access Though in its infancy, telemedicine is expected to compel healthcare providers to reimagine their business processes in next few years. For instance, telemedicine can aid in conducting trials to discover cures for infectious diseases. Infectious diseases are more likely to spread in secluded communities and remote areas, and telemedicine offers the capability to reach deprived or physically inaccessible patients. 9
Integrating telemedicine in clinical trials will enhance the sponsor's reach across a wider geography, even while working with a centrally-located, lean team of highly-skilled medical professionals. Additionally, it eliminates the need for hiring local physicians and other professionals to facilitate trials in remote geographies. However, companies will require experienced technicians who can conduct clinical trials through telemedicine. Harnessing Big Data and analytics to improve study design Digitization of clinical trials enables the storage of voluminous patient-related data in various forms. Pharma companies are looking at leveraging this data to improve efficiency of trial execution. Advances in Big Data and analytics enable sponsors to derive meaningful patterns and insights, as well as predict future outcomes. This helps stakeholders take accurate decisions regarding continuing the trial. Big Data can also be leveraged to predict the drug's time-to-market as well as derive the patterns of adverse drug reactions across the population. This will support the post-marketing surveillance of the product. Speeding up the Process and Improving Efficacy of Clinical s Digitization has begun to revolutionize the clinical trial industry. By converging existing methods with analytics, cloud, social media, and mobile technologies, sponsors will be able to enhance the accuracy of clinical trials, while depending on a framework that simplifies compliance with regulatory guidelines. Adoption of technology has improved the efficiency of clinical trials, providing a platform with the promise of faster drug discoveries. With the onset of Health 2.0 technologies, healthcare professionals are looking forward to a paperless industry that will significantly optimize the way the industry functions. 10
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