Conversations around making clinical trials more patient-centric have well and truly come to the fore, shifting attitudes away from traditional methods. Translating these discussions into reality is already underway, in large part due to the COVID-19 pandemic. A (very small) silver lining of the pandemic – at least for clinical trials – has been the accelerated adoption of decentralized trials, or even hybrid models, that greatly reduce the burden on patients. However, it’s not only patients that look to benefit, as these methods open up new possibilities, and can help to partially insulate CROs and trial sponsors from unforeseen circumstances such as those seen in recent years. As a result, the industry has reached a turning point, with decentralized trials now firmly embedded and ready to further evolve, ensuring that 2022 and beyond will have a different looking landscape.
Working together with patients in mind
This new course is providing fresh opportunities to the industry itself, the benefits of which also filter down to the patients. We are seeing the formation of new organizations for the provision of visiting nurses, and the establishment of specialized decentralized clinical trial groups, both of which will help to improve the consistency of studies and the continuity of the professionals seeing the patient. Healthcare companies are also becoming more heavily involved, and the de-identified data they have of a patient’s medical history could greatly assist a trial. These companies are starting to collaborate and lean on each other’s strengths, forming partnerships to drive new clinical trial models for future success.
A closer look – unrivalled patient retention
The term decentralized clinical trial has long been synonymous with patient-centricity – and for a good reason. The benefits are well established, and offer patients unmatched levels of convenience. Yet the knock-on effects – most notably, increasing patient retention rates – are often overlooked. Patient recruitment is a huge investment of time and resources, making it extremely important to encourage each participant to continue to the end. If a patient drops out two months into the trial, then another patient must be recruited, which is expensive and prolongs the study timeline, ultimately delaying any application for the drug’s approval. Although decentralizing a trial is initially more expensive, the cost must be balanced against how this method improves patient retention.
However, decentralized or hybrid models shouldn’t be seen as a magic bullet to ensure 100 percent retention. We may be preaching to the choir here, but communication and education are still vital factors to increase patient confidence and drive higher retention rates. In many cases, patients may have questions they don’t know how to formulate: Why are they participating? What are the clinical endpoints? What does this mean for them? Could it give them, or someone they know, a longer or better quality life? Empowering patients with answers to these questions can help them to understand the importance of their ongoing participation.
Opening new doors
As the pharmaceutical industry searches for novel drug development approaches to resolve unmet medical needs, decentralized trials may not only be beneficial, but necessary to obtain accurate data. For example, research is emerging into the use of psychedelics to treat CNS conditions, such as PTSD, and DMT-assisted therapy has already been trialled in the UK. It’s difficult to operate a trial with psychedelics in a clinic – often a stressful environment – and a patient will generally feel more at ease in their own home, where they can be observed in a relaxed setting to generate better data. Another example is trials for pain medications, where minimizing the placebo effect is crucial to obtaining accurate data. Again, a patient in the comfort of their home may provide a more balanced overview of how the drug candidate is affecting their perception of pain.
Decentralization also potentially allows patient inclusion criteria to be broadened, opening the door to underserved populations and enhancing the robustness of the trial. For example, patients who aren’t able to travel to a clinic – those with a debilitating disease, or paediatric and geriatric cohorts – can now be more easily included, and in greater numbers, opening up greater opportunities.
Driving the evolutionary engine
As clinical trials evolve, new hurdles are emerging, and these must be promptly negotiated to provide a clear path forward for drug development. The numerous challenges arising in recent years – from both external factors and as a result of novel approaches – have tested sponsors, CROs and Woodley Trial Solutions like never before. Brexit and the COVID-19 pandemic, as well as the introduction of the In Vitro Diagnostic Regulation (IVDR) in Europe – a major regulatory overhaul of the IVD market – and the European Medical Device Regulation (MDR) have proved burdensome, forcing rapid changes across the entire industry, and a lot of retooling on our part. How to manage the increase of data from new technologies has become imperative, and this is something that we’ve added to our toolkit to be able to even better support our customers.
The complexities of running a decentralized clinical trial are further added to by ever-changing global supply chains and logistical challenges, as well as geographical regulatory disparities, which can seem unfathomable for some. Yet these hurdles aren’t immovable objects, and innovation in clinical trials will help to drive drug development and patient satisfaction to unchartered territory. Woodley Trial Solutions has been at the forefront of this innovation for over 30 years, and we continually apply our experience to new innovations and technologies, helping our sponsor and CRO clients to enhance their studies. The recipe for success is constantly changing but, with all the ingredients at hand, we will continue to make clinical trials painless for our customers, so they can better support patients.
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