To address the challenges faced in patient recruitment and retention in clinical trials innovative technologies are being utilised in AsiaPacific as well as other regions to optimise the processes involved From patient matching to improving the consent process technology has the power to help Biopharma organisations in Asia Pacific transform clinical development
Patient recruitment and retention is frequently the most laborintensive and difficult part of the clinical trial process and is often a barrier to the successful completion of a study. Industry data indicates that patient recruitment can represent more than 30 per cent of total study costs and sponsors bear a tremendous cost when ambitious recruitment goals, often misguided, fall short. Asia-Pacific is one of the most successful regions in terms of the speed at which study sites complete the start-up process and begin recruiting patients. It is also the top region in terms of achieving target enrolment levels. However, because it comprises a large number of culturally diverse countries, patient recruitment and retention strategies, there is a need to be more targeted and tailored to individual countries than is required in other regions. In recent years, a number of technology innovations, such as eConsent and patient portals, have been adopted by pharmaceutical companies and CROs to aid this process. However, the extent to which different technologies are utilised varies between North America, Europe, and Asia-Pacific. This article reviews some of the patient recruitment and retention technologies and how some of that technology is applied in Asia-Pacific.
Finding the right sites and patients for the right trial
Recent technological developments have shown how technology platforms and cognitive computing power is helping automate the cumbersome process of identifying patients who meet the criteria for a clinical trial, and how these can be used to analyse protocols to assess trial feasibility. This is allowing better access to patient populations and the increased information available enables site and patient recruitment to be optimised, with improved matching of patients for clinical trial participation. Clinical and laboratory data from Electronic Medical Records (EMR) can also identify suitable investigators and patients. Patient profiling is used to create a profile of the typical patient for each trial, which helps to target the correct patients. Technology solutions, such as using patient registries and online forums, are also playing a part in the transformation of this area by being used to directly recruit patients and improve patient retention by providing an additional communication channel to standard doctors’ appointments.
One important technologic advance that is being used in Asia-Pacific as well as other regions is the cognitive computing power of IBM’s Watson. Watson is the first commercially available cognitive computing capability representing a new era in computing. The system, delivered through a cloud, analyses high volumes of data, understands complex questions posed in natural language, and proposes evidence-based answers. Watson continuously learns, gaining in value and knowledge over time, from previous interactions and can be used to help automate the cumbersome process of identifying patients who meet the criteria for a clinical trial and to analyse protocols to assess trial feasibility and identify optimal trial sites. It can rapidly identify how many patients match a clinical trial’s inclusion criteria, where the patients are located and how they will be recruited. The Watson Health Cloud facilitates access to anonymised patient data by enabling the massive amount of personal health data being created daily to be anonymised, shared, and combined with a dynamic and constantly growing aggregated view of clinical, research, and social health data. IBM has opened a new research centre in Singapore this year and it aims to expand its offering into Asia, with healthcare being one of the focus areas.
Using a web-based patient portal enables more patients to easily find a suitable clinical trial available for their therapeutic area, clinical trial information on patient criteria suitable for those trials, and is also specifically designed to enhance a patient’s understanding of a study before consenting to participate at an investigator site. A patient portal ensures that they have ample time to review consent materials, and prepare any questions before the face-to-face meeting with the investigator. Improved patient education leads to a more informed consent process which not only has the potential to increase patient recruitment but also increase the likelihood of the patient staying on the trial, because they know what to expect. Portals can also enable pre-screening questionnaires and selection of a convenient study location, all designed to make it easier for the patient to participate in the right trial. Other features include enabling investigators to engage directly with a patient who has expressed interest in participating in a trial at their site, schedule visits, and examine live analytics about the materials the patient has reviewed. Research has shown that patients prefer to learn about the trial through the more accessible medium of video and the information provided in this format is more easily understood as it transcends language barriers and provides consistency across sites.
A truly informed consent process
The informed consent process is a prerequisite for patients’ participation in clinical trials, but difficulties can occur when the expectation is for patients to read and understand informed consent information, which typically can consist of documents containing more than 20 pages. These documents are essential to properly convey the trial activities and procedures, but are often full of complicated medical terminology that can be difficult for patients to comprehend. In addition, the increasing complexity of many clinical trials and trial protocols means that more time is required to complete the consent process, which in turn leads to greater costs.
Using electronic consent (eConsent) helps to improve the consent process while reducing the time and cost of the consent process. Presenting information visually on a screen rather in a printed document can be much more easily understood and retained, helping patients to comprehend the information and, therefore, providing truly informed consent. For example, providing a 3D visualisation of how a drug works in the body is much easier to understand than reading a paragraph about a drug’s mechanism of action. Key information that influences a patient’s decision to participate in a trial can be provided in an interactive, engaging format, using a multimedia approach comprising elements such as video, text and graphics.
eConsent enhances the patient consent process for not just patients, but also investigators, site staff and sponsors. It effectively supports the investigator in communications with the patient and other study staff by providing more education and introducing more consistency and compliance in the trial.
Improving patient recruitment and retention with wearables
The increasing popularity of fitness and wellness devices is well documented, with device manufacturers and technology giants creating a digital mobile health revolution in which individuals can now monitor different aspects of their health status, such as heart rate, sleep quality, and exercise rate, as part of their normal daily routine using wireless-enabled wearable technology devices. But how can this technology be used to improve the clinical trial process and in particular to support better patient recruitment?
We now have the means to innovate the ‘where’ and the ‘how’ of patient data capture to create a 24-hour digital map of physical behaviours and quantifying daily life; but the use of sensors also has the potential to reduce the patient burden of having to travel, in some cases long distances, to a centralised site on a regular basis and instead create virtual sites in a patient’s home. Wearable technology devices, with their ability to collect and transmit physiological parameters, are a key component of decentralised data collection. They can be used not only to generate clinical data but are also valuable as screening and compliance tools. For example, specific sleep or activity patterns can be monitored where these form part of the study inclusion criteria or are a required component for the duration of the study. While the industry is still learning about the value and practical use of wearables in clinical trials, its potential to support patient recruitment and retention is considerable.
Asia Pacific – varying degrees of implementation
The use of technology in patient recruitment and retention in Asia-Pacific is, in some respects, more advanced than in other regions, as governments embrace technology as a more efficient way to deal with the increasing burden of healthcare costs. For example, the Republic of Korea is the only country in the world that uses a single technology platform for the electronic medical records of the entire public health system. Japan uses just three platforms for electronic medical records compared with the many different platforms used in European countries and the hundreds of fragmented and unintegrated platforms used in the USA. The challenge in Asia-Pacific is not the implementation of technology but rather its commercialisation. Much of the healthcare in Asia-Pacific is public and there are legal and regulatory barriers to the commercialisation of government-funded data for the benefit of private companies. An exception is India, where the majority of healthcare is private but highly fragmented and is, therefore, challenging to integrate nationally. In addition, because Asia-Pacific is a very culturally diverse region that comprises half the world’s population, a technology that might be useful for patient recruitment in one country or even a province may not be applicable in another country or province.
The Korean government established the Korea National Enterprise for Clinical Trials (KoNECT) in 2007 to encourage clinical research in the country. The services that KoNECT provides for foreign sponsors of clinical trials include a onestop shop giving comprehensive access to information about Korea, concierge services for smooth entry into the country, and business matching with selected local service providers. Asia-Pacific regional clinical trial networks and a national clinical trial integrated information system and database are being developed. KoNECT provides aggregated and analysed data directly from electronic medical records to support clinical trial patient recruitment.
Private for-profit patient recruitment companies also leverage technology. For example, the Japanese company CROee uses the clinical trial information website Seikatsu-Kojo WEB to help recruit patients. Patient information in Seikatsu-Kojo WEB is organised by different categories, such as disease, medication, and blood type, so the database can be searched to identify suitable candidates for a clinical trial according to various factors. Once identified, suitable potential candidates can be contacted in a number of ways, including uploading of study information to the website, direct mail, and e-mail magazines. Members who are registered with Seikatsu-Kojo WEB are those that either want to take part in clinical trials or have expressed an interest in doing so.
Evolving to meet the challenges
Asia-Pacific continues to have great recruitment potential for clinical trials, with its large and diverse patient populations and proficiency in achieving fast study start-ups and patient enrolment targets. In some countries, such as Korea, there have been great strides to use innovative technologies and this trend is likely to continue into the future. As in other regions, technological advances are constantly being employed by pharmaceutical companies and CROs in Asia-Pacific to transform and improve clinical development including patient recruitment and retention.