Patient-Focused Drug Development

Karen Josey says deploying individuals such as Nurse Educators can guide patients from enrollment and informed consent all the way through to the end of the trial

Excerpts from PharmaVOICE, April 2019

While many in pharma speak of “patient centricity,” the industry has been slow to design programs to adequately support and provide human-to-human interaction, for example, deploying individuals such as nurse educators who can guide patients from enrollment and informed consent all the way through to the end of the trial, says Karen Josey, VP, business development, VMS BioMarketing.

“Some new roles and new tactics have emerged within pharmaceutical companies and CROs — for example, patient liaisons, direct-to-patient (DTP) teams, patient Web portals — but our industry still has a long way to go toward giving patients the full measure of support they need while participating in a clinical trial,” she says.

Ms. Josey of VMS BioMarketing says involving patients early in drug development to assess their perception and commitment to being in a trial and taking the drug being developed is the key to compliance with the drug in the future. Even the simple action of interviewing patients in person versus sending a survey or email would be a tremendous enhancement. “Employing trained medical personnel such as nurse educators would help pharmaceutical manufacturers learn about what dosage modalities and timing would help a patient be most compliant,” she says.

“Talking to patients in advance about possible side effects of the drug being studied would help manufacturers understand patients’ level of tolerance and help them learn what education is needed in order for the patient to enroll and stay in the trial. By discussing potential risks associated with the drug or study would help manufacturers understand patients’ ability to assess risks and what trade-offs they are willing to make in their lifestyle to participate in the trial and continue to use the drug after it is approved.”

“Manufacturers and CROs must not overlook or downplay the emotional needs of patients,” Ms. Josey warns. “In a recent study that analyzed 500,000 de-identified and anonymous public comments that occurred in public online forums for patients living with chronic diseases, researchers found that six of the top eight unmet needs are emotional concerns rather than medical concerns.”

Ms. Josey says when patient-focused drug development is being used in clinical trials, the impact is very positive in terms of enrollment and recruitment.

“Considering 48% of sites miss their enrollment targets, and 80% of trials are delayed due to recruitment, the impact manufacturers and trial sites can make in supporting the patient from informed consent to the conclusion of the trial can only be a win-win for everyone,” she says.

“For example, engaging a nurse educator in a patient-focused clinical trial will help find the right patients, inform the patients/caregivers more effectively, screen patients more effectively, get stronger buy-in from the patient/caregivers, help avoid delays and keep the patients in the trial until the end.”

Read more in the April 2019 issue of PharmaVOICE