Innovations in patient recruitment coupled with thoughtful local implementation are a step forward in our relentless pursuit to simplify the patient journey
Today, there are many innovative, new approaches to patient recruitment and the number continues to grow. The driver behind these innovations is the challenge that many western countries face in recruiting patients for participation in clinical studies.
The concept of patient recruitment is quite simple. It involves recruiting the right patients, at the right time, and in the right numbers. However, we encounter hurdles in applying a ‘one size fits all’ approach for these innovations, and to ensure successful enrolment, the recruitment tactics should consider local needs and challenges.
In Asia, there are challenges unique to the region for clinical trial recruitment, compared to the western world. For example, in China with a population of 1.4 billion people, the shortage is not in patients, but in site staff capable and experienced at delivering quality clinical trial results. On October 8 this year, the China Food and Drug Agency (CFDA) announced a new site certification process. Hospitals are now able to self-register as a clinical trial site, with the responsibility for qualifying such sites lying with the study sponsors. As a result, the number of clinical sites is expected to rapidly increase within the next few years. For the coming wave of new sites in China, strong partnerships/collaborations with investigators and sites that enable them to deliver will be a key factor for success.
In Japan, the challenges are different, and more similar to western countries. There is more competition for a limited patient pool and the population is shrinking. Frustration with the limitations to the current approaches is creating a market that is more and more open to new ideas. Data-driven feasibility is just beginning to gain acceptance and patient-centric approaches are also attracting attention.
Such an environment requires innovative approaches and strategies, which are tailored to these markets.
Innovations can come in the form of products and process improvements. Global innovation coupled with thoughtful local implementation is essential to succeed. To accomplish this, one needs to hire and develop the right talent, and work with the right partners, to foster innovations, develop them, and subsequently implement them in the best possible way.
Local implementation of patient recruitment innovation requires knowledge of not only the challenges, but also the needs of the specific markets.
In 2016, BMC Women’s Health published a study titled “Barriers and facilitators for clinical trial participation among diverse Asian patients with breast cancer: a qualitative study.” The study was conducted in the NCCS, which treats 75 per cent of cancer patients in Singapore and has a yearly outpatient attendance of more than 130,000. In this study, various focus groups studied females over the age of 21 with breast cancer, who were able to provide informed consent and attend the focus group by themselves. The study examined the factors that influence patient recruitment into clinical trials in Asia, each factor showcasing an area of clinical trial recruitment with the potential to lessen the patient burden and improve the overall experience. These were found to include:
1. Knowledge and Attitude: Several patients in the study said they had not heard of the term “clinical trial,” and many that had heard of the term were previously or currently enrolled in one. This lack of familiarity would be a potential hurdle for recruiters, because patients would be less likely to seek out clinical trials if they had no concept of their existence. However, it turned out that 80 per cent of the participants asked for more information about clinical trials, showing that there is a desire for information, but inadequate means to obtain it.
2. Reasons to Join: This study highlighted the individual, medical and societal factors affecting the patient’s decision to participate in clinical trials. One deciding factor for some of the women in the study was how the study was introduced to them. The women preferred and were more trusting of studies that were introduced to them by their doctors–highlighting the need for clinical trials to work with local institutions and within the local Asian community to target potential patients.
3. Relaying the Information: Another important take away from the study is that many participants said simpler language and visual aids, such as recordings and pictures should be used to relay the ICFs (Informed Consent Forms) and other information regarding clinical trials – including promotion of other clinical trials. Recruiters need to simplify the information and tailor it to audiences to make it easier for the patient to understand.
The study conducted by BMC Women’s Health shows there is an opportunity to improve how we approach clinical trials. The industry is rapidly embracing patient centric methodologies, as a means to improve the patient experience, with the potential to improve recruitment rates, increase compliance with study procedures and reduce withdrawals. Increasingly technologies such as “web listening” are being employed to more accurately analyse the sentiment of patients and caregivers, as well as identify key influencers related to a specific indication. For Asia, this requires adapting technology for local languages, as well as differences in social media preferences. This approach allows companies to fine tune their approaches to provide valuable information about the disease, therapies, as well as the availability of clinical trials.
Investigator sites are critical to the success of any clinical trial. PAREXEL alone has value-driven partnerships with hundreds of clinical sites across the world, of which one in four sites are located in Asia, to support drug development for our clients’ investigational medicinal products. These sites, located in Japan, China, Korea, Taiwan, and in key countries throughout the rest of Asia, provide a means for patients to not only access innovative, new therapies, but have an improved clinical trial experience. Creating these partnerships in Asia isespecially important for trial participation and diversity, as shown by the FDA in the 2015-2016 Global Participation in Clinical Trials Report where the majority of Asian trial participants in global studies were at non-US sites.
Identifying the right sites isn’t easy. Data-driven feasibility is an approach to support site selection. Unfortunately, it is highly dependent on the robustness of the data being employed. For some countries, historical data is sometimes scarce, depending on the indication or drug’s mechanism of action. This entails augmentation, which requires tailoring the approach to what is optimal in the specific country. In Japan and China, collaboratingwith Site Management Organisations (SMOs) that provide study nurse dispatch services to clinical sites has proven effective, in addition to other country-specific approaches.
Patient recruitment doesn’t end with identifying the patient, but requires the patient to consent to participate in the clinical trial. For the patient to give consent, they must first have a comprehensive understanding of the study. Some tools on the market try to make this information easily digestible with the use of animation to provide the patient with an overview of the study and related information – these tools are being actively used in China, Taiwan, Korea, and Japan. Such tools are often tailored culturally with voice overs in the local language and with animation that not only appeals to young children, but also adults and elderly patients, due to the ease of comprehension. There have already been increased trial consent rates, improved compliance /retention and shortened recruitment timelines in the studies where these tools have been implemented. An important factor is ensuring that the animation is culture agnostic and therefore acceptable in these very particular markets, and the simplicity of implementation is important to meet the needs of highly variable site environments.
Approaches for patient recruitment must have one thing in common: they must make things simpler for the patient. Participating in a clinical trial is filled with anxiety and uncertainties, especially coupled with existing challenges from the underlying disease. Reducing the anxiety and clinical trial burden are obvious steps to make things simpler for the patient.
The industry has decades and decades of experience in running clinical trials. However, as treatments continue to evolve, there is a need to advance the way we run the clinical trials, to not only provide evidence of efficacy and safety, but to also gain further insights into how we can provide additional value for patients and investigator sites. Innovations in patient recruitment coupled with thoughtful local implementation are a step forward in our relentless pursuit to simplify the patient journey.