Clinical Supplies Management - How to adopt direct-to-patient methods in clinical trials

Increasingly complex clinical trials, such as those involving rare diseases or dispersed participant patient populations, call for increasingly complex distribution models. These studies are literally impossible to carry out using a traditional supply chain model. The CEO and president of Clinical Supplies Management, Gerald Finken, is a pioneer in the field of direct-to-patient clinical trial methods. He explains the challenges that must be overcome when moving to this innovative patient-centric approach.

The direct-to-patient (DtP) platform is a patient-centric approach to clinical supplies in which the materials are prepared, packaged, labelled and then shipped directly to the patient's or caregiver's home. This innovative method enables sponsors to avoid shipping to and storing supplies at clinical sites, allowing cost reductions, shorter timelines and improved quality. Furthermore, by shipping directly to patients, the DtP platform enables sponsors to conduct trials that would be all but impossible with traditional supply chains: trials involving a rare disease, orphan indication or dispersed patient population.

Clinical Supplies Management (CSM) became the first company to offer DtP services in a large-scale clinical trial over two years ago, when a pharmaceutical sponsor with an incredibly complex trial approached the company to find a solution.

The trial - which involved an orphan indication, a refrigerated medication with a 48-hour shelf life, only two participating sites in the US and a dispersed patient population consisting entirely of minors - simply could not have been completed with a traditional supply chain model. The importance of the study, coupled with the obstacles faced by the sponsor, inspired CSM to create the DtP platform, preparing the patient kits On-Demand and delivering them directly to the homes of patients.

This approach, though beneficial to sponsors and critical to the success of trials such as the one described, will take time before it is adopted throughout the industry. As the pioneers of the DtP platform, CSM would like to offer some helpful insights on how other companies can overcome the obstacles they might face when introducing a DtP method into their business.

The challenges of DtP

The first, and most important, obstacle every company must face is the fear of change, internally and externally. Internal fear comes from within the company itself, in the form of learned habits. Decision-makers become accustomed to certain budgets, practices and timelines. Changing these can be stressful, as any lack of success is likely to be blamed on that change, whether or not it was truly responsible. Overcoming this fear requires decision-makers first to recognise it and then to find the courage to see failure as a stepping stone to success.

The external fear of change comes from outside, adjacent businesses, which fear that disruption will bring an end to their financial security. While, for example, a camera company might have been excited by the opportunities of the digital era, one can guarantee that film companies were not; it is the same in the pharmaceutical industry. There are many stakeholders invested in maintaining the current system of clinical trials, and they will fight tooth and nail against change, thinking it easier to maintain than to adapt.

It is this fear, however, this resistance, that is why, despite all of the technological progress in the past 30 years, timelines have not been reduced, drug approval rates have not increased, and the same questions about increasing development costs continue to be asked but not answered. Sponsors must learn to distinguish between companies that argue against change because of legitimate patient safety concerns and those that argue merely to protect their own interests.

The second obstacles many companies will face is assuring each entity in their supply chain that the DtP method will not blur the line between GMP and GCP. The sponsor is still responsible for packaging, labelling and distribution, and the investigator is still responsible for control of the drug during investigation and for maintaining adequate records. Only the location of the hand-off from GMP to GCP has changed: instead of a receiving department or a site, it is now at the home of a patient or caregiver.

The third obstacle to implementing a DtP programme lies in outdated methods of quality assurance. Many clinical research companies still implement quality by inspection rather than quality by design. While quality by inspection is important in the commercial setting, it often works to inhibit innovation in the realm of clinical research as that kind of quality control requires planned deviations every time something new occurs. Companies can pre-empt this challenge by moving towards a quality-by-design system of quality assurance.

Innovative opportunities that arise with the implementation of DtP

Although DtP methods have not been used extensively in clinical research, they have become standard in the commercial setting. Millions of prescriptions are shipped directly to the homes of patients every year. Comparing these commercial practices with clinical research practices yields several opportunities for expansion of the DtP platform.

CSM is involved in the next phase of the DtP platform: the Clinical Trials Research Pharmacist (CTRP®) service. This service allows pharmacists to communicate directly with patients or caregivers, in their own homes, on behalf of the sponsor and investigator. Just like in the commercial setting, these pharmacists work with clinical trial patients to ensure proper use, compliance and adherence.

CSM is currently working to provide for and allow e-prescribing and On-Demand labelling to enable the investigator to write patient-specific prescriptions. This will allow investigators the ability to craft detailed instructions unique to any patient, which, when coupled with DtP methods, will help eliminate the mishandling of clinical supplies at the site.

CSM is also looking to provide DtP shippers that are a fraction of the size and weight of current shippers. This will drastically reduce distribution and shipping costs, especially for temperature-sensitive products. In fact, the DtP shippers may even be the actual kit box that the clinical supplies are packed in. Technology can even be built into the shipper to provide tracking, temperature, light and other critical measurements.


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The importance of the study, coupled with the obstacles faced by the sponsor, inspired CSM to create the direct-to-patient platform, preparing the patient kits On-Demand and delivering them directly to the homes of patients.
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