Direct to patient clinical trials are a decentralised clinical trial model where aspects of the trial occur outside the main trial site.
In traditional clinical trials, patients travel to the investigator site and commit to this for the entirety of the study, which can present a significant burden for patients depending on their disease profile or even location. As approximately 70% of US potential participants live more than two hours away from a study centre, many may be reluctant to contribute to clinical trials (1).
In decentralised clinical trial models, the phases of traditional trials are monitored with the same blinded protocols but often are conducted at the patient’s home, workplace or pharmacy instead of a study centre, significantly increasing the likelihood of participation and improving patient experiences. There is also an increasing integration with digital technology such as wearable sensors and telemedicine to allow for remote and direct patient monitoring.
A recent study comparing clinical trial designs found that the decentralised arm with virtual telemedicine visits had an 89% patient completion rate, compared to the 60% completion rate in the conventional on-site study arm, in addition to the expedited recruitment observed in the decentralised arm. This decreased attrition rate is promising and highlights that adapting trials to patient lifestyles and schedules would reduce delays in the clinical trial timeline, and benefit those involved, including the clinical trial administrators, pharmaceutical companies and other sponsors and other parties involved (2).
The COVID-19 pandemic increased the demand and use of technology for healthcare visits, e.g., via telemedicine. Similar needs and trends were also seen in the clinical trial. Digital consent forms and remote monitoring have been used in some trials to continue testing in a safe yet controlled setting. Those who partake in remote or direct to patient studies feel more secure, directly influencing retention rates and patient satisfaction. Another advantage of these new digitalised and direct to patient settings is the ability to constantly collect real-time, continuous data and in turn improving the quality of the research outcomes.
Without the hostility of some clinical settings, direct to patient settings facilitate the communication of insights and patient-centred endpoints. This almost “collaborative” nature of direct to patient trials provides valuable patient feedback that can shape treatment or product experiences (1).
Taking advantage of this changing trend in decentralised clinical trials, Neucruit has recruited individuals with high self-reported levels of worry to take part in the ‘Worry Reduction Training’ Study conducted by a clinical and academic team at King’s College London. Eligible users were recruited in October and November 2020, and completed assessments after receiving a virtual training on coping mechanisms for worrying, all from the comfort of their home.
Allowing Neucruit-users to choose the studies they would like to participate in we hope to contribute to the improvement of clinical research practices and outcomes.
Anderson DF, Jonathan, Elsner N.
Digital R&D: Transforming the future of clinical development. Deloitte; 2018.
Sommer C, Zuccolin D, Arnera V, Schmitz N, Adolfsson P, Colombo N, et al.
Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain. Contemporary Clinical Trials Communications. 2018;11:120-6.