The 2017 CISCRP Perceptions and Insights study found that 60% of patients and caregivers listed the physical location of the research study centre as very important in influencing their decision to participate in a trial.
The study further found that the location of the medical centre was ranked highly as a least-liked aspect of the clinical study experience, second only to the possibility of receiving a placebo. Several other least-liked responses were related to the time burden the trial placed on the patient.
It’s clear that reducing the burden that clinical trial participation places on patients can help to keep patients engaged in clinical research, but what can we do to progress this concept?
Reducing patient burden
Sponsors and CROs are already searching for ways to reduce patient burden and this has spurred industry efforts toward patient engagement and patient-centricity, which have branched into specific trial methodologies like telehealth, remote/ virtual trials and direct-to-patient strategies.
We’re all familiar with the concept of these innovative trial designs and some pharmaceutical companies are already exploring how to operationalise decentralised and hybrid trials.
The 2nd Annual Patient-Centric Benchmark Survey, released in April 2018, showed that 86% of pharmaceutical industry respondents ranked the importance of delivering on patient-focused missions as greater than 8 out of 10, but only 21% were confident in their own company’s ability to deliver on these missions.
This perhaps reflects that best practice in execution is still evolving and there are some unresolved areas such as remaining compliant within research regulations, the technology investment required, the impact on data endpoints and ensuring patient compliance adherence when visits are conducted at home or alternate sites.
Reducing the travel load and increasing the geographic outreach
The time spent travelling to an investigator site can be burdensome, both from a convenience standpoint and because of physical barriers with different disease states. In a 2018 survey from the Society for Clinical Research Sites (SCRS) of 527 investigational site participants, 81% said quality transportation is important for recruiting and retention purposes.
In addition, clinical trials for rare diseases can be so geographically dispersed that patients may need to travel very long distances to participate in a trial. What if, instead of transporting patients to investigational sites, we shift our focus to bringing clinical trials to patients in their home to ease this burden?
Benefiting the patient and the sponsor
Bringing clinical trial visits to patients in their homes has been proven to lead to higher enrolment and retention rates. Patients are less likely to miss visits due to travel barriers and regular clinician contact may lead to better compliance compared to direct-to-patient models that don’t integrate home visits.
This can increase the success of clinical trials and will also shorten development timelines, bringing new treatments to market faster and reducing the overall cost of clinical research.
In addition to quicker enrolment and reduced drop out rates, in-home visits also have the potential to support sponsor business objectives. In fact, according to the 2nd Annual Patient- Centric Benchmark Survey, 85% of those employed by the biopharmaceutical and medical device industry agree that focusing on patients’ needs leads to better business outcomes.
There are also several reasons why in-home visits are beneficial to the patient and caregiver:
- Convenience to participate without affecting school, work, family or community obligations
- Ability to participate in research regardless of mobility challenges
- Flexibility to schedule trial visits during evenings, weekends or holidays
- Reducing stress and fatigue from long or frequent travel.
The hybrid approach
However, it doesn’t have to be an all-or- nothing scenario when it comes to in-home visits. Services can be customised to meet
the specific trial requirements so that home visits are only used for specific visits, protocol activities, sites or patients.
This way, the trial can be a hybrid of traditional and innovative designs, depending on the needs of the trial and the comfort level of the sponsor.
This hybrid method can also ease the burden on site staff, while keeping them involved in all trial activities. The home care partner completes the designated visits, including thorough documentation which is sent to the site upon completion of each visit.
By working directly with patients to schedule their home visits, the home care worker eases the study management responsibilities for site staff. Lastly, home visits lend themselves to providing more real-world data, as any drug application is occurring in the patient’s home environment.
This may be more representative of real-world administration and can be indicative of consumer use once a drug is in the market.
Extract from “An Actionable Approach to Decentralized Clinical Trials to Grow Enrollment and Retention” Melissa Hawking, Symphony Clinical Research (Part of ICON plc) June 2019
Gretchen Goller, Global Head, Patient Recruitment and Retention Solutions, ICON plc
