Direct-to-Patient (DtP) practices in clinical trials is a market few players are willing to take on for now. Too high are the requirements that patient-centred trials impose. They make clinical trial design even more complex and increase the strain on all stakeholders to cooperate even closer. Besides, they demand an even greater flexibility and reliability of logistics procedures. So why should anyone turn to Direct-to-Patient practices in clinical trials? The answer is simple: It is worth it.
Problems conventional clinical trials are facing
Recruiting participants for conventional clinical trials is a difficult undertaking. It is time- and cost-consuming to convince participants to enroll in a clinical study and remain until it is completed. Patient-recruitment makes up 32 % of the total trial budget. Thus it is the most relevant factor responsible for increasing clinical trial costs. 50 % of clinical studies are delayed due to patient-recruitment issues – a costly delay affecting not only study costs, but also subsequent sales with losses between 600.000 $ and 8 million $ per day. That is why it is all the more painful to lose already recruited patients during a clinical trial. 30 % of patients drop out at an early stage. One of the reasons they do so is that the site visits are too stressful for them and that they cannot match the trial with their daily schedule. It is clear that participating in clinical trials that involve regular visits to the clinical site obviously provides a severe inconvenience for the patients.
Why Direct-to-Patient practices are the solution
Means to render clinical studies more comfortable for participants is therefore an important goal in conducting clinical trials. And here is where Direct-to-Patient practices come in. DtP implies that the investigational medicinal products (IMPs) are being delivered from the production site (via hubs/pharmacy) directly to the patient´s home. Biological samples are collected at the patient´s site and are then being forwarded to the central laboratory for testing. The patient´s home gets a central locality in this clinical approach and the focus of the latter is set on the patient.
The logistics 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 (MRN) 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 effect, Direct-to-Patient services facilitate access to new participant groups: People that live at a great distance from a trial site and people whose physical state does not allow for regular visits to a trial clinic. Moreover, with fewer participants dropping out, studies can be completed faster and with more reliable results.
3 big hurdles for Direct-to-Patient services
This is all promising, but why then is not every one switching to Direct-to-Patient services? There are three major hurdles to overcome and to consider:
- Hurdle 1: Since Direct-to-Patient practices are a new approach, most governments do not specify regulations on how a clinical trial with this approach should be conducted. So DtP services operate in a blurry area – regulatory speaking.
- Hurdle 2: Direct-to-Patient services, at least for now, cannot be applied to each and every trial. They are most suitable for the health care of elderly people, of children and adolescents as well as for patients who need orphan drugs. Overall, the approach makes sense when no intervention is needed as is the case in a biopsy for instance.
- Hurdle 3: The DtP model requires a close collaboration between stakeholders. Logistics providers, nursing organizations and hub or pharmacy staff have to work together seamlessly to ensure each patient gets the intact medication in the predetermined time window. This is a complex and demanding undertaking.
It is but a matter of time when Direct-to-Patient practices will see a break-through in clinical trials. The players already on the market take on an important role in paving the way. The future has always belonged to the bold.