World Courier Management prides itself on being global but personal, placing value in each trusted partnership that it forms with customers. The company shares its clients' commitment to improve global health by gaining a holistic understanding of their strategic business objectives. By designing and executing world-class logistics processes that mitigate risk, maximise the return on R&D investments and advance medicine, this speciality logistics company is the best choice for optimal handling, transport and delivery of vital healthcare products.
When it comes to clinical trials, one of the greatest challenges to overcome - one that should be felt long before the actual study begins - is the recruitment and retention of qualified patients. Finding patients that are willing to participate and that can work their personal and professional schedules around the study's requirements - including trips to the hospital, availability of doctors and study medications - has grown increasingly difficult. Challenges to overcome include the time required to source and keep patients, the global nature of trials and possible unpredictable delays to the study. When time is critical, these are major concerns that can impact manufacturers' bottom lines. By moving the trials from hospitals to patients' homes, it becomes easier to recruit trial patients and facilitates faster completion of important studies.
The clinical trial model is in a gradual state of decline, chronically eroding the ability of sponsors to recruit and retain patients. As traditional trials get larger and more complex, more invasive for patients, and require more data for regulators, it has become difficult to find patients to shoulder that burden, and for sponsors to expedite clinical studies. The industry, however, is responding. A key feature of the new movement in trials is to make them patient-centric - and this is done by bringing the study to patients' homes and addressing their issues of consent.
The traditional model is site-centric - structured and managed for decades using investigative sites to see patients. Despite being costly to set up, 83% of US sites only participate in a clinical trial once. This indicates that the site-centric approach does not work. The industry may be better served financially to emphasise patients' needs. Almost 80% of patients would find it helpful to have their drug therapy delivered to their home rather than travel to the investigator site. In the old model, everything revolved around the investigational site. The clinical research associates, the nurses and the patients were all required to travel to the site for things to happen.
This presents a number of challenges, such as identifying and securing investigational sites relative to the geographic reach of the relevant patient pool, and travel time and distance for patients - so only those closest tend to participate in the trials, which restricts the population. Then there are the travel costs, such as petrol, tickets and parking fees. These demands can deter patients and, even if a patient can be convinced to participate, the commitment and subsequent impact to their lifestyle often leads to high drop-out rates, particularly for very sick patients for whom the burden can prove too much.
In the direct-to-patient (DtP) model, the labs, drug therapies, healthcare workers and test equipment go to the patients at home. Typically, around 50% of visits can be done in the home. A subsequent improvement in patient retention rate of up to 95% can be seen. All of this helps to improve the efficiency and timeliness with which to complete studies.
Of course, DtP models are not without their own challenges. Varying regulations and GxP policies based on global GDP guidance can present a number of hoops through which sponsors must jump. The distribution model requires not just the ability to ensure integrity in cold chain clinical supplies, but also the ability to deliver within predetermined times, and transport potential patients' samples from the home visits. Comprehensive protocols must be created and enacted to ensure regulatory compliance. A comprehensive understanding of local regulations and implementation makes all the difference to success. In general, regulators tend to be supportive of home-care trials, as they see such efforts able to deliver better care to patients. Different countries have different regulations regarding what procedures can be performed in patients' homes; how and when drugs can be administered to patients under a certain age; what medical supervision is required; how IMP can be compounded, stored, prescribed and transported to patients' locations.
It is generally the case that DtP is best suited for trials that have IMP suitable for home administration, with multiple clinical visits, which do not require a physician's assessment or have physician medical assessments that can be done over the phone. If patients are in remote locations, or the study drugs have difficult logistics - for example, if there are large amounts of cold chain products - they can benefit from delivery to their home. The more complex the study - orphan, geriatric and paediatric patient populations, for example - the more attractive a DtP study will be.
Patient confidentiality is paramount; countries' specific requirements differ and confirmation of the legal requirements must be completed by submitting the protocol to the relevant authority. When patients sign up for a home trial, they must be informed of, and give consent to, home visits as well as the release of their data to third-party organisations.
Although patients are only referred to by unique identifiers and not by name, protecting their confidentiality and the integrity of the study is paramount. This rigid protocol does not only extend to the nurses and researchers, but also to the speciality logistics company and drivers that will visit patients' homes. The address details can be matched up without delivery drivers needing to know patients' identities. In the case of home-trial services, the names of nurses or healthcare professionals can be listed as the contacts for jobs. The house 'airway bill' that is used to deliver the shipment must be 'blinded' so that confidential information is controlled effectively. Drivers should avoid spending significant time waiting outside patients' homes, and should not communicate with neighbours and strangers about the nature of the delivery. Drivers are also restricted from asking patients how they are feeling or anything else that could be considered as giving healthcare advice or information.
It is becoming more apparent that the DtP model of home visitation for clinical trials is quickly becoming the way of the future. The current practice of recruiting patients via social media, for example, is only a small step forwards, and provides little actual benefit for the patient. Placing patients at the centre of everything, and adding more of a human element to the process, provides better access to patients, but also makes it more likely that they will follow through with the study as their needs are placed at the forefront of the clinical trial. The benefit, in an increasingly competitive market, is that studies are completed more quickly and efficiently, which can help improve overall time to market and product access to a broader patient population.