In recent years, industry has been looking for ways to modernize the traditional clinical trial model. As such, companies are now being encouraged to try methodologies and strategies that will streamline processes and introduce more flexibility and efficiency, while still yielding high quality and meaningful results. The use of homecare nursing in clinical trials is one example of this.
Homecare nursing brings the trial to the patient by allowing nurses to administer treatments and monitor outcomes in the patient home. This eliminates the need for clinical trial sites and allows local nursing teams to carry out the responsibilities of the traditional study site staff.
There are a number of benefits to providing this service, both to the patients and to the study sponsor. The most obvious benefit is that it reduces the burden to patients and their families of being enrolled in a clinical trial. Patients save time, money and effort, as they no longer have to travel to and from a site or organize any care for dependents during their absence from the home.
The reduced burden to patients, in turn, leads to higher recruitment rates into the trail. Patients who would have been unable to enroll under the traditional set-up, due to the inability to access the clinical trial site or leave their home, now become viable options. Similarly, once patients are enrolled and the trial begins, Sponsors can expect higher retention rates, as reduced burden will lead to greater patient satisfaction.
For sponsors that do not experience difficulties recruiting and retaining patients, and actually experience the opposite problem of not being able to recruit all the patients that wish to be enrolled, homecare nursing can also provide a solution. As patients will be treated in their individual homes by local nursing teams, there is not the same overall workload on one team at a clinical trial site. The workload is spread across different nursing teams which allows sponsors to enroll more patients or run additional trials.
A final important benefit of homecare nursing in clinical trials is that treatment is received in the everyday setting, which more accurately reflects how a drug will be used, once it is approved. Receiving treatment at a clinical trial site has long been the gold standard because it is a highly controlled setting which is cleaned and monitored regularly. However, in reality, once a drug is available on the market, it will usually be taken by patients in their home setting. Understanding how a drug works when administered in the home during the clinical trial is, therefore, beneficial to the sponsor and helpful for regulatory bodies reviewing an NDA for drug approval.
WEP Clinical has recently partnered with Wren Healthcare to be able provide homecare nursing as part of our service for sponsor companies. Click the link below and check out our services page to find out more.