MedCity Influencers, Pharma

What are some misunderstood complexities of bringing clinical studies to patients’ homes?

The concept of direct to patient clinical trials is still a relatively new concept, especially on large, phase III multinational clinical trials.

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In a continually competitive and challenging market, patient-centric clinical trials are becoming increasingly important to biopharmaceutical companies who are keen to bring their drugs to market quickly and safely. One way to attract patients to clinical trials is to provide the treatment at home. This requires arranging, packaging and distributing trial supplies and supporting materials / devices to the patient’s home, as well as collecting laboratory samples from the patient’s residence.

This article explores the key drivers of direct-to-patient (DTP) services, highlights misunderstood complexities, and makes recommendations on how to simplify execution and bring about benefits to patients participating in – and companies running – clinical trials.

Why are DTP services important?

Some factors driving interest in patient-centric clinical trials include: a lack of available patient groups for some indications, a lack of investigators for orphan disease trials and steep competition in clinical trials specific to common medical indications.

Patients are seeking leading physicians to treat their condition. Through the help of DTP services, patients have access to clinical trials, specialist centers and physicians that previously would have been considered too remote.  Providing medication direct to the home is of great convenience for patients who are home bound, have mobility restrictions, are in outpatient care or need support to attend site visits.

With biopharmaceutical companies facing increased pressure to recruit and retain available patients, the cost of drug development is rising.  Whether the clinical trial is investigating an orphan disease or a highly competitive indication like diabetes, the application of DTP services embedded as part of a wider strategy for e-clinical or “virtual” trials may improve the availability, recruitment and retention of patient groups through treatment of the patient at home by site-trained homecare nurses. The additional benefit of connecting the patient to the trial through wearables and electronic devices expands the reach of the trial site to participate in research where a limited number of qualified investigators or available patients exist. It also creates competitive advantage for biopharmaceutical companies by developing the clinical trial around patient choice.

From protocol to execution – key considerations to apply

There are various complexities to consider to successfully implement a DTP strategy within the clinical trial.  The concept is still in its relative infancy, especially on large, phase III multi-national clinical trials. In-country medicinal rules and regulations are not clearly defined, resulting in local ministries of health approving each protocol on a case-by-case basis.  There should be a separate section within the clinical protocol to explain the process, ethical considerations and justification of why DTP is required and how it supports the patient’s safety and treatment, and protects the patient’s data privacy.

Implementing DTP also has important considerations for the feasibility of country selection. Clinical operations teams will need to consider the impact of DTP on their site selection, qualification and initiation processes.  Specific clauses need to be included in site and pharmacist contracts outlining DTP arrangements and training processes.  Informed consent forms should be developed outlining DTP descriptions, and ethic committee approval must be obtained for direct patient contracts and other patient documents.

For delivery of medication to a patient’s home, many countries require a licensed in-country pharmacist to dispense medication. While internet pharmacy licenses are increasing in popularity, clinical trial laws and ICH Good Clinical Practice remain and must be built into the logistics framework.  Either the clinical site pharmacy or a depot (where allowed) will store the study drugs and hand shipments over to a specialized courier for delivery to the patient’s home. A process must be developed to securely transfer the patient’s data from the clinical site to the courier, without spreading this sensitive data to the sponsor. It is also necessary to obtain shipment data and proof of delivery while operating within the data privacy rules determined by local country law. Shipping temperature-controlled or dangerous substances to the patient’s home can create a varied or complex situation. Medication also has to be ensured that it is received in good order, stored and dispensed according to specifications. If medication is to be stored in the patient’s home, specialist temperature gauges significantly help with transferring data as required.

The common approach to DTP involves site and pharmacy personnel working directly with the courier and homecare organization to make the necessary shipment bookings. As DTP becomes fundamental to global clinical trial strategy, the burden placed upon the site may not be sustainable, with operating costs at risk of spiralling out of control.  The use of a validated and flexible interactive response technology (IRT) system integrated with mobile applications, temperature monitoring systems and patient engagement tools can:

  • streamline the clinical trial process, significantly reducing site burden
  • ensure secure capture, storage and transfer of patient data
  • improve visibility of shipments throughout the supply chain, with the objective of minimizing and tightly controlling any medication overage

The use of IRT also enables simplified drug returns, accountability and reconciliation from the patient’s home to the site or depot under the full supervision of the clinical research associate.

DTP services fundamentally change the design and execution of running a clinical trial, with touchpoints spanning the full spectrum of delivery requirements.  As DTP services become a pivotal concept within the global trial design strategy, biopharmaceutical companies should consider speaking with a single service provider, such as a clinical research organization (CRO), who can easily navigate the changing environment and has well-established connections with required stakeholders, to reap the full benefits of DTP services and bring drugs to market quickly and safely.

Photo: sam_ding, Getty Images

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