August 14, 2019
At Frenova Renal Research, we start with the patient in mind: It’s our fundamental philosophy. But what does that mean? And why is it important?
In all the complexity of conducting clinical research, its purpose — improving health — is easily misplaced. However, keeping patient needs and desires in focus benefits not only patients like Donnie King (see below), but also clinical investigators and sponsors.
At Frenova, through our understanding of patients with kidney disease, we assist investigative sites in improving their research efforts and helping clinical research sponsors succeed. The following snapshot of one patient’s life and views illustrates how an examination of study patients’ daily needs and activities can inform an investigation’s approach.
What Matters to the Patient: Donnie King’s Story
The following details were gathered from a patient interview.
Donnie is 65 and has ESRD with high blood pressure, diabetes, and gout. He spends 4.25 hours at dialysis, three times a week. Every week.
Unlike others he knows, however, Donnie generally tolerates dialysis well. It doesn’t exhaust him, and on his four off days, he does his best to keep active — through gardening, for instance. While his diet restricts him from eating most of the vegetables he grows, he enjoys giving them away.
Donnie approaches his role as a study patient with an attitude of thanks. He feels good about participating in clinical studies because of their potential to benefit all renal patients — and receiving a stipend for his participation helps, too. In fact, one reason he has never missed a study visit is that he sees his role as a study patient as his “job.”
Donnie relies on his caregivers at the dialysis clinic to inform him of new study opportunities. That in-person touch is essential. “Hands-on is a lot better than paper,” he says, concurring with statistics from the Center for Information & Study on Clinical Research Participation: Person-to-person explanations are more likely to result in study participation than less personalized forms of outreach such as ads, direct mail, or internet sources.
He also relies on trusted caregivers for clarification of consent forms and advice on whether to participate. He is naturally hesitant to enter a study that could cause discomfort. “Blood pressure drop and cramping are rough,” he notes. So, when a study listed those issues as possible side effects, he was ready to decline — until his research coordinator pointed out that the study drug was simply a different form of a drug he was already taking. Furthermore, he felt the study was worthwhile as it was testing an oral dosage form that might be used instead of an injection.
For Donnie, participating in a research study makes going to dialysis more pleasant. He says the extra attention, care, and appreciation he receives from study personnel makes him feel special. He still recalls the day he had a toothache and a considerate caregiver took notice and scheduled him a dental appointment. That kindness left a big impression.
“It’s just unimaginable how it makes you feel when somebody comes up and says, ‘Are you doing good today? Is everything okay today? Do you need this today?’” says Donnie.
How Knowing What Matters to the Patient Helps the Sponsor and Investigator
As exemplified by the draft FDA guidance, “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input,” using patient input to improve research and care is a current trend, with good reason.
While aggregating the opinions of many patients would offer a more accurate picture of patient needs overall, we can still infer a lot from Donnie’s story about probable best practices and potential pitfalls in study design and recruitment strategies for patients on dialysis (see table).
Implications of Patient Concerns and Beliefs for Study Design and Recruitment Strategies
The concerns listed below correspond with those voiced by Donnie.
|Patient Concerns and Beliefs||Significance for Sponsors and Study Design||Significance for Investigators and Recruitment|
|Concomitant conditions||Factor likely coexisting conditions into decisions about what patients can do and tolerate||Manage appropriately and ask about/ameliorate symptoms as much as possible|
|Dialysis is time-consuming||Limit time patients must spend at clinic beyond dialysis||Help patients feel welcome, comfortable, cared for, and entertained — better engagement should improve adherence and decrease dropout|
|Transportation may be an issue||Limit patient commitments to dialysis times and locations||Adhere to a regular schedule as public transport is inflexible and support people have limited time to give; find ways to help if needed|
|Dialysis leaves many patients exhausted||Time and gauge study activities accordingly; avoid processes that are too tedious or complex|
|Dialysis diet is very restrictive||Bear in mind when formulating study drugs/SOPs, if relevant|
|First month of dialysis is especially difficult||Higher likelihood of dropout if subjects are new to dialysis||Extra encouragement will be required; allow time to acclimate before starting study|
|Altruism is a motivator||Focus on this in recruitment efforts|
|Payment is a motivator||Be as generous as you can, compensating for all possible expenses||Focus on this in recruitment efforts|
|Caregiver is best source of study opportunities||Inform caregivers of the important role they play||Inform patients of studies — a good experience with one study increases likelihood patient will do another|
|One-on-one recruitment efforts work best||Individual conversation is likely the best recruitment strategy in this population|
|Patients need help understanding new studies||Take time to explain in full and answer questions|
|Patients may rely on a trusted caregiver in decision-making||Building trust with patients is key|
|Certain side effects may be perceived as deal-breakers||Learn what patients actually fear/dislike the most and try to address concerns|
|Ideal that recruiter knows the patient well||When possible, recruiter should be familiar with the patient|
|A worthwhile study goal matters||Recruitment will be easier if study goals make sense to patients||Choose studies patients find relevant|
|Receiving special care/support is a motivator||Spend as much time with each patient as possible|
|Being thanked for participating is important||Thank patients||Thank patients|
Sponsors designing ESRD studies must carefully limit the burden their protocols place upon patients. At the same time, to succeed in recruitment and retention, investigators must expend significant time interacting with patients. In either case, a true understanding of these patients’ daily reality is requisite for success — and that’s where Frenova excels.
Like no other partner, Frenova comprehends the ESRD research landscape and the physical and practical complexities of living with ESRD. Our specialized insight, vast patient pool, network of high-performing physician investigators, and extensive data assets enable us to anticipate renal patients’ needs and assist renal research sponsors and investigators better than any other clinical development services provider.
We can help design protocols that will be both palatable and feasible for patients and investigative sites. A well-considered protocol translates to easier and faster recruitment, better adherence, and better retention of study patients. Additional benefits for sponsors may be faster study completion with avoidance of costly and time-consuming protocol amendments.
In addition, our site management services can help investigators organize and streamline research activities, giving them time to personalize recruitment efforts. And with more time to forge stronger connections with current patients, investigative teams encourage greater trust and engagement. The result is better adherence and retention, an increased likelihood of repeat study participation, and better research business performance.