There are 30,000 clinical trials going on worldwide of which 7,000 are in Phase III1. The costs are high per patient at around $41,4132 and $3,000 per clinical site visit.
With a sharp shift towards decentralised clinical trials (DCTs) during the pandemic and beyond, pharmaceutical and healthcare companies are reaping the many benefits of digitised trial techniques. Lower costs, higher data quality, and a more convenient and improved patient trial experience are some advantages. In essence, DCTs have transformed clinical trials and brought drugs to market sooner and cheaper.
However, only 15% of trials complete on time3 and as delay costs money this means just 10% of the trials are accomplished on budget. Patient centricity is key to achieving higher levels of success. Focussing on the patient and how to make the trial easier and more tailored to their needs can significantly improve patient adherence, outcomes, recruitment and retention. Whilst embracing digital transformation, patient engagement must be made a priority with the investment of holistic patient support services throughout the clinical trial.
More clinical trials will adopt decentralised elements
DCTs use digital tools including apps, wearable devices, e-consent, electronic Patient-Reported Outcomes (ePRO), and telemedicine. They move trial activities to participants’ homes and local surroundings.
In practice, there is a broad spectrum of decentralised, traditional and hybrid clinical-trial designs. It is expected that decentralised elements will continue to be incorporated into traditional trials and the increase in the number of home-based trials will carry on.
The benefits of DCTs are numerous and include improved patient accessibility, diversity, and retention. Reducing a patient’s participation time and cost eases the burden of the clinical trial. This delivers higher retention rates and efficiency. Also, DCTs can attain more diverse and representative populations which has been a long-term problem in clinical trials.
Yet, there are various DCT challenges such as a patient’s comfort with and access to technology, trial communication and transparency, and the logistics of study participation that need to be strategically addressed and planned for.
The obstacles facing clinical trials
To keep clinical trials safe, compliant, and effective, the difficulties of clinical trials need to be carefully considered with a view to overcoming them. Three key clinical trial obstacles include:
- Low quality patient data collection. Patient Reported Outcomes (PROs) are often not completed, incomplete, or completed at incorrect times and clinical trial staff respond inconsistently to this which introduces bias into the collected data.
- Patient non-adherence is a major long-standing problem in clinical trials that effects trial outcomes, end points and validity, and raises costs.
- Recruitment and retention can be poor due to lack of awareness, miscommunication, financial costs, and travel time, and may result in non-representative patient samples that would fail validity tests and the non-completion of the study.
A need for patient-centric decentralised trials
Clinical trial participants are people who are often managing health conditions whilst living busy lifestyles with work commitments and raising families. 70% of clinical trial participants live more than two hours from the clinical site4 and so travel and accumulated costs can make this difficult for them.
Poor adherence in clinical trials can be due to multiple factors, including forgetfulness, concerns about side effects, lack of understanding of the importance of taking the drug in accordance with the prescribed methods, perceptions that the drug confers no benefit, and patient drop out due to being overburdened.
A major barrier to patients using digital tools is their access to them and their digital literacy. Often patients are uncomfortable using technology and apps and do not have a suitable device or access to the internet. Patients in clinical trials with a complex registration process will not have the confidence to progress. They may be unaware or lack understanding of how digital health intervention could help support their healthcare and concerned about the security and privacy of digital information and interaction. Communication about the trial may feel impersonal and of poor quality.
Understanding the root cause of clinical trial obstacles allows trial teams and digital health intervention providers to provide a patient-centric digital connected health platform.
Digital patient engagement programmes increase the success of clinical trials
Patient engagement programmes are increasingly emerging as a priority. A patient-centric clinical trial model can significantly improve its adherence, outcome data and retention.
Digital patient engagement services put the patients at the centre of the clinical trial. They have the goal of better medication adherence by helping people start, continue and complete their clinical trial treatment regimen. This is the glue between the patient and the clinical trial.
Denis Reynders, Global Business Unit Director, Digital Health Services, Stefanini EMEA says: “Patient centricity offers patients a way of communicating with the caregivers, the doctors and all the clinical personnel in the most effective way for them to ultimately increase adherence and keep the patient in the programme.”
Stefanini’s Patient Engagement Services
Stefanini has advocated for a long time the need to focus on the patient and facilitate their experiences at every stage of the clinical journey. They have developed Patient Engagement Services to understand and influence patient motivations and behaviours that enhance adherence to clinical trial protocols.
Their Patient Engagement Services combine a helpdesk, digital tools and a wider set of options based on individual preferences and needs to optimise clinical trials and overcome obstacles. The team proactively helps patients and study personnel navigate the complexity of clinical trials while providing support in logistics and technologies. Patients become part of a supportive patient-centred ecosystem that encourages and inspires.
Reynders says: “The patient services Stefanini is offering are geared towards putting the patients at the centre of clinical trials and also alleviating the burden of site personnel getting involved with tasks that are not necessarily clinical, medical or administrative and not linked to their job profile. Items like booking appointments, sending medical kits, doing outbound calls, and any support for adherence in the patient journey is very important. Therefore, Stefanini is shifting important tasks to our Patient Engagement Services and not the clinic. This is where the real value sits. “
Stefanini’s Patient Engagement Services were designed with the express purpose of boosting patient engagement and retention and reducing the administrative burden on clinical site personnel by streamlining patient flow and automating numerous routine tasks.
Using this service can shorten trial timelines, increase the patient’s experience and satisfaction, enhance relationships with sponsors and the site, and possibly lead to less expensive trials.
Some of the many services offered by Stefanini to patients and site personnel include health and trial education, communication and coaching; digital technology provision and training; non-clinical task assistance; automated scheduling for medication alerts and shipments and patient appointments; passive and electronic real-time data collection; and advanced data-driven analytics.
The Bottom Line
The landscape of clinical trials today and in the future will embrace digital transformation, prioritise patient centricity and engagement, and invest in patient support services. This will increase patient adherence and retention and improve trial outcomes and efficiency.
- Moore T J et al, 2020, Variation in the estimated costs of pivotal clinical benefit trials supporting the US approval of new therapeutic agents, 2015–2017: a cross-sectional study, BMJ Open.
- Market Scale: 85% of Clinical Drug Trials Face Delays. What’s the True Cost? Published January 2022.
- McKinsey: No place like home? Stepping up the decentralization of clinical trials. Published June 2021.