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Diversifying Your Participant Pool with Direct-to-Patient Trials

As the struggle to identify and recruit patients to clinical trials continues, many organizations are turning to direct-to-patient (DTP) studies. DTP trials offer significant benefits throughout the research chain – but there are some challenges. Therapak have been exploring the benefits of using DTP studies to diversify your participant pool.

An Introduction to DTP Trials

A DTP trial is a patient-centric approach where trial supplies are delivered directly to the patient’s home. Whether they’re known as virtual, decentralized or remote trials, DTP is widely considered to be the future of clinical study.[1]

The Clinical Trials Transformative Initiative (CTTI) lists the following as reasons for research organizations to consider decentralized clinical trials:[2]

• Faster trial participant recruitment, which can accelerate trial participant access to important medical interventions and reduce costs for sponsors.
• Improved trial participant retention, which may reduce missing data, shorten clinical trial timelines, and improve data interpretability.
• Greater control, convenience, and comfort for trial participants by offering at home or local patient care.
• Increased diversity of the population enrolled in clinical trials.
• An opportunity for home administration or home use of the IMP (Investigational Medicinal Product), which may be more representative of real-world use post-approval.

Drawing on Therapak’s extensive experience within the DTP landscape, we have put together the four major benefits of the DTP trial model.

Benefit 1: Participant engagement

DTP trials free participants from the obligation and hassle of attending a registered trial site. Globally, 60% of potential clinical trials participants consider the location of the study center to be ‘very important’ in their decision to take part in a trial[3] and what could be simpler that conducting the trial in your own home?

The flexibility and simplicity of DTP trials:
– Increase interest
– Shorten recruitment
– Reduce cost[4]

DTP trials are particularly relevant to those studying rare conditions, says the CTTI. The model allows the recruitment of dispersed populations, across countries or continents, enabling you to target those with rare diseases or conditions.

Well-designed DTP trials can empower participants, making them feel fully involved in the process. It’s the definition of patient-centricity[5], helping to tackle criticisms of on-site trial designs; that they can be ‘meaningless’ or ‘disempowering’ for those who take part.

Benefit 2: Reduced recruitment cost

The benefits of improving recruitment should not be understated.

Research funded by the U.S. Department of Health and Human Services (HHS) estimates the patient recruitment and retention costs to be three percent of trial budgets (or approximately $2.28 billion per year[6]). Consider the fact that up to 30% of participants drop out of their trial once it has commenced, and the potential for DTP trials becomes even more obvious.[7]

There are clear benefits for the organizer too, with non-traditional trials allowing operators to break free from traditional – and costly – supply chains. By delivering kits directly to patients, site costs are dramatically reduced. You no longer need to kit out, mobilize and manage facilities – and with this the perennial problem of downtime disappears. Operating on a just-in-time principle, wastage and storage costs can be reduced – benefits that can be truly realized when working with a trusted supplier.

Benefit 3: Fit-for-purpose

Expecting patients to self-test requires significant management and education. Optimizing the patient experience is a key challenge in developing a strong trial design. Participant requirements must be clearly understood from the start.

Innovative technology is making it more possible for organizers to monitor patients from afar. Technology such as wearable devices have been revolutionary in helping to maintain contact between participants and trial organizers, a subject our partner MESM has written about before.

DTP trials are just one way that medicine is becoming more individual. The rise of personalized medicine also brings new opportunities, as treatments are targeted towards narrow groups of patients for greater effect. With this comes the broadening of diagnostic and genetic lab testing, marketed direct to patients themselves. This complements clinical research trials and the DTP approach to wider testing.

Benefit 4: Partner approach

The possibilities inherent in DTP trials are much greater than the challenges, many of which can be effectively mitigated by robust study design. Where there are complexities such as feedback collection, the CTTI recommends that a hybrid model, with at home testing balanced with on-site visits and consultations, may be more appropriate.

The CTTI itself cautions that DTP trials are challenging and recommends that organizations consider partnering with an experienced vendor to deliver an effective study.

Therapak has significant experience. We have:
– Supported DTP trials globally
– Produced direct-to-patient kits for commercial diagnostic lab applications, as well as clinical trials
– Distribute clinical trials kits and materials across the world

We are a global partner and can support your DTP trial with invaluable local insight. With kits which can be tailored and standardized for each trial or test, Therapak can help to make your DTP trial personal and considerate to every participant involved.

Why you should consider a DTP trial model

The DTP model gives participants the all-important Peace of Mind as their unique needs are being considered. At the vanguard of personalized medicine, bespoke solutions will make for more positive experiences, increasing trust and reducing clinical trial drop-out with all the commercial and patient centric benefits these generate.

 


[1] Covington, D. (2019). The Remote Patient-Centered Study Approach in Clinical Research. [online] Applied Clinical trials. Available at: http://www.appliedclinicaltrialsonline.com/remote-patient-centered-study-approach-clinical-research [Accessed 30 Apr. 2019].

[2] Decentralized Clinical Trials. (2016). Clinical Trials Transformation Initiative. Retrieved 29 April 2019, from https://www.ctti-clinicaltrials.org/projects/decentralized-clinical-trials

[3] (2019). Ciscrp.org. Retrieved 29 April 2019, from https://www.ciscrp.org/download/2017-perceptions-insights-study-the-participation-decision-making-processs/?wpdmdl=8768&refresh=5cc6e534784441556538676

[4] Sweeney, M. (2019). Direct-to-Patient Clinical Trials: Strategies for Success. [online] Applied Clinical trials. Available at: http://www.appliedclinicaltrialsonline.com/direct-patient-clinical-trials-strategies-success [Accessed 30 Apr. 2019].

[5] Mullins, C., Vandigo, J., Zheng, Z., & Wicks, P. (2014). Patient-Centeredness in the Design of Clinical Trials. Value In Health, 17(4), 471-475. doi:10.1016/j.jval.2014.02.012

[6] 3 Analysis of Costs. (2015). ASPE. Retrieved 29 April 2019, from https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development/3-analysis-costs

[7] The issue of patient retention in clinical trials – CenterWatch News Online. (2016). CenterWatch News Online. Retrieved 29 April 2019, from https://www.centerwatch.com/news-online/2016/06/27/issue-patient-retention-clinical-trials/