Taking the trial to the patient
World Courier’s partner in the direct-to-patient model, the Medical Research Network (MRN), discusses the evolution of clinical trials.
Traditional clinical trial models are becoming extinct; patients are better educated through the internet, sites are overwhelmed with trials, protocols are becoming more complex, regulators are becoming stricter and sponsors are looking for faster trial delivery.
Today, 30% of sites recruit less than one patient…retention rates have dropped 48%…one in four patients drop out of trials before completion…94% of patients have no access to clinical trials… it’s not going well it? So something has to evolve!
Putting the patient in the centre
Patient centricity is the buzz ‘phrase’ in the industry today, but just how patient centric has the industry become? At MRN it’s all about the patients, everything we do is designed around the patient to make trial participation less of a burden and a more viable option for patients.
When MRN started 10 years ago, the conduct of protocol defined visits in the patients home was a totally new concept; we were instrumental in carving out the niche which many refer to today as home healthcare in clinical trials; we call it Home Trial Support. Our model was initially based around the administration of parenteral IMP in the home, though over time this has expanded to cover all visits and assessments that can be completed by a nurse using portable equipment. It’s this history of administering parental IMP and the vast experience of the MRN management team that makes us the market leaders in these more complex home healthcare visits.
The administration of IMP in the patient’s home is, of course, not a new concept; patients have been taking oral IMP at home for years! Administration of parenteral IMP, with a proven safety profile, is no more a risk today than sending a patient home with their tablets.
Many of the IMPs we administer in the home require temperature controlled delivery and that’s where our partnership with World Courier was founded; without their expertise and geographic coverage, we wouldn’t be able to conduct some of the trials we are involved in. We can rely on the IMP being delivered to our nurses, at the patient’s home, under the correct conditions and within a 15-minute window across all 38 countries we are currently covering.
Where we are also taking blood samples, be that for safety or PK etc, we can also rely on World Courier to be there, on time, to collect, package and deliver those samples to the lab reliably.
A vision for the future
Our vision has always been to push clinical trials into the community; the traditional models are failing and virtual models can leave patients with no human contact and the healthcare they are often seeking when they agree to a trial. We see a future where patients are identified, or identify themselves, via the internet and enrol into a trial at one of perhaps a handful of sites in each country; with the majority of visits being done in the home, the distance to that site is less of an issue, they don’t visit there very often! All IMP can be delivered to the home, be that oral or parenteral, with nurse administration and support as required. All data can be collected online, both by the patients and the nurse, with infrequent site visits covering the physician required assessments or those requiring equipment we cannot transport.
Fewer sites, patient-centric approach, faster enrolment, increased retention, with reliable dosing and data collection … perhaps the evolution of trials is already happening.
Find out more about the World Courier and MRN partnership:
http://www.worldcourier.com/products-services/clinical-trial-logistics/mrn-partnership
