In a way direct to patient services in clinical studies are not a particularly new trend. Back in 1747 one of the godfathers of clinical trials, the Scottish doctor James Lind, carried out the first documented controlled intervention trial on the spot, where his patients worked and lived: on-board the HMS Salisbury, sailing along the French coast. He proved in an experiment with 12 sailors that scurvy could be prevented by eating oranges and lemons.
The pain of patient-recruiting and -retention
Today it is far more difficult to recruit participants for clinical trials than back on-board the HMS Salisbury, of course. It is a time- and cost-consuming procedure to convince participants to enroll in a clinical trial. Patient-recruitment makes up 32 % of the total trial budget and hence is the number one cost driver. That is why it is all the more painful to lose recruited patients during clinical trial. 39 % of patients dropping out early state, they find site visits stressful and 16 % of patients that actually completed a trial say the same. So the inconvenience to regularly visit the site is among others a major obstacle to patient-retention.
Why direct to patient services could be the answer
Ways to make the trial more comfortable for participants is therefore an important goal in planning future clinical trials. One mean, which is being broadly discussed at the moment, is direct to patient service. That implies that the tested drug is being delivered from the production site (via hubs/pharmacy) directly to the patient´s location. Moreover, this patient-centric approach could also contain the retrieval of biological samples by a homecare nurse.
The logistic service provider Marken states that the direct to patient approach has a positive impact on patient retention and that the compliance is just as high as studies conducted at an investigator site. According to the Medical Research Network the direct to patient model has increased patient recruitment by up to 60% and has helped maintain patient retention at over 95%. As a further positive side effect, direct to patient services could facilitate access to new participant groups: Especially people that live a great distance from a trial site can profit from direct to patient services. Moreover, with fewer participants dropping out, studies can be completed faster and with more reliable results.
The most important hurdles to direct to patient services
This all sounds very promising, but there are quite a few hurdles to overcome and to acknowledge in direct to patient services. As this approach is quite new (though not quite s. James Lind), most governments do not specify regulations on how a clinical trial with the patient-centric approach should be conducted. That is one reason why only reluctantly direct to patient services are being integrated into clinical trials. Most of all, to ensure the blinding of samples was and still is quoted as a main objection, but several companies have found a way to assure that.
Direct to patient services, at least for now, cannot be transferred to any type of trial. They are most suitable for the health care of elderly people, of children and adolescents as well as to those patients who need orphan drugs, who have long-term treatments and so on. Overall, the approach makes sense when no intervention is need as is the case in a biopsy for instance. Here, to visit a clinical site is inevitable.
The challenges for logistic providers
Logistic providers have realized the need to prepare for the growing number of trials that integrate the direct to patient approach. Against this background and the fact that a growing number of temperature-sensitive medication is undergoing clinical trials, what scenarios await logistic providers?
Scenario 1: Medication is being delivered by logistic providers directly to the patient´s door in an adequate cooling box. Either the patient takes over the medication within the box and then returns the latter on the next delivery or the patient returns it instantly. Either way, only reusable boxes are sensible, here.
Scenario 2: Medication is being brought by homecare nurses from the site pharmacy to the patient´s home. Here, cooling boxes are required that can be easily and safely transported in a car and can be carried easily by hand.
Scenario 3: A stationary cooling solution is being installed in the patient´s home which secures the right medication preservation. This stationary cooling device is being filled on a regular basis.
All scenarios ask for flexible, reusable, secure, small-volume easy-to-use cooling solutions. These need to cope with the complexity direct to patient services represent. With Nelumbox we want to meet this challenge. We want to help in putting the patient at the center of clinical trials in the future.