By Graham Wylie, CEO, Medical Research Network Ltd.
The continuing rise of patient-centricity within the drug development industry is a crucial consideration for sponsors when designing their clinical development plans. With initiatives such as the FDAs Patient-Focused Drug Development Program, patient experience and voice within a clinical trial is becoming increasingly important and will have a direct impact on what solutions and services patients require to ensure they participate and stay in clinical trials.
What makes a trial patient-centric?
There are a number of tools and services which are labelled as ‘patient-centric’, from branded study schedules and guides designed to educate and inform the patient, to using social media to promote and recruit patients. All of these services place the patient experience at their core, but do these tools really impact the patient in a powerful enough manner for them to be patient-centric? We don’t think so.
Clinical trials are really not patient-centric; of course, the patient has always been considered as a stakeholder, but how much benefit does a clinical trial hold for the patient? Recruited patients may get the comparator or placebo drug, they could experience serious side effects, or they may have poor access to the drug after the trial. Patients may not be able to get the approved drug when it arrives on the market, because it is too expensive or it does not launch in their own country. To top it all, patients have to visit the clinical trial site constantly – often much more than in the course of their standard of care treatment.
The cognition that a trial provides a chance of improving a patient’s health is not enough to call a trial patient-centric. Rather, a patient-centric solution has to recognize that the patient is in fact burdening themselves to participate in a trial and it must work to minimize the impact of the trial on their life. This will make participation by the patient more feasible and increase the likelihood of consent, in turn speeding up the trial.
Home Clinical Trial Visits – The Solution
Traditional clinical trials often require multiple, frequent investigator site visits for patients to have procedures such as blood draws or drug administration conducted. This can place a large burden on patients and their families, which inevitably impacts both patient recruitment and retention. Home clinical trial visits aim to reduce this burden by taking the trial to the patients home.
Research-trained homecare nurses can conduct a number of procedures in the patient’s home, ranging from simple blood-draws and assessments to complex intravenous drug administration. This is enabled by mobile centrifuge units, ECG units and other technologies including electronic-data-capture in patient’s homes, which means clinical development teams can really focus on improving trial experience for the patient.
Managing homecare visits for a clinical trial in multiple countries requires careful planning, strong project management, and a robust network of experienced homecare nurses. With each country having its own laws and regulations around what can and can’t be done in a patients home, it’s important that a homecare provider understands the local regulatory landscape and consults with the sponsor to design a clinical protocol that is not only approved by regulatory authorities, but is also legally and logistically practical in each country.
There are number of tools focused on patient recruitment and retention, but few can be seen as patient-, site-, and sponsor-centric.
Clinical investigator sites benefit because homecare clinical trials provide better, more convenient care for their patients. Home visits mean that site staff can focus their time on other activities, and importantly there is increased patient recruitment and patient retention, leading to better site performance.
For the Sponsor and CRO providing a patient-centric model through homecare clinical trials provides them with a method to provide the patient with convenient, tailored care. Trials also benefit from enhanced drug compliance – drugs can be administered directly by the nurse, or under their supervision. Trials benefit from better patient retention rates, as patients do not miss site visits; the nurse comes to them. Opening up the trial to homecare also means patients can access a wider net of patients, whilst opening fewer clinical trial sites.
Sponsors will also have an advantage over other competing trials, which use the standard on-site visit model.
Placing the patient at the centre of a trial
Some of the biggest challenges of delivering a successful clinical study are identifying, recruiting and retaining patients. Developing a strategy that places the patient at the centre of your clinical trial is vital for a successful clinical study.
This direct-to-patient clinical trial model has shown that supporting a patient through a trial in their own home reduces the number of visits to site and significantly lessens the burden on patients and their families. This ease of participation directly increases patient recruitment by 60% or more and typically maintains retention at over 95%. Performing a number of visits in the home also lessens the resource burden on clinical sites, allowing them to enter more patients or run more trials, thus increasing the likelihood of better health outcomes.