September 19, 2016
Patient Centricity in class I, II or III medical device studies, an opportunity to improve your reputation
Over the past few years, patient centricity has become a much heard buzz-word when discussing health care and health care related industries. In clinical trials, patient centricity refers to the concept of shaping a study design around the patient. “No decision about the patient, can be made without the patient” . Generally speaking, it is more likely that a patient will participate in a trial, when the trial design revolves around the patient. Additionally, having a patient centered trial design seems to influence patient perception of medical device manufacturers .
In a recent survey conducted on 463 international, national, regional and local patient groups from 58 countries it was shown that having a patient centered trial design was the most important strategy to improve corporate reputation with patients and patient groups. However, only 37% of surveyed patients believed the medical device industry has a good or excellent record in having a patient centered strategy, indicating that there is much to gain in this field for both medical device manufacturer and patient .
There are several ways to implement patient centricity in your medical device study. First of all, limit procedures to those that are truly necessary for the outcome of the clinical trial and that require less patient visits. The easier it is for a patient to be compliant to a clinical trial visit schedule, the better the retention will be . Traveling is time- energy- and cost-ineffective and instead, home visits, visits to a local hospital, or follow up by email or phone could relieve this burden. Technological innovations like specially designed applications for tablet, smartphone or PC, where visits are completed electronically could further minimize the visit schedule. For example, by using an application to capture (post market) clinical data for a class 1 medical device, hospital visits might not even be required.
Also, it is advised to maintain regular contact with the patient, and inform patients about (preliminary) results of the study. In the aforementioned survey only 30% of patients think the medical device industry is good or excellent at “managing adverse news about products”, and only 36% of patients think the industry is good or excellent in “acting with integrity” . Data transparency and sponsor-patient communication is key in enhancing the medical device industries reputation, in this area.
Another way of making a clinical trial more patient centric is to seek patient input by early engagement in the trials study design . A lack of information provided to the patient, together with a lack of understanding of the clinical trial leads to a negative influence on the patient, and might be a cause for non-participation . By asking patients to review essential study documents at an early stage it can be defined which parts of the study are unclear or confusing to a patient so amendments can be made. If information regarding the clinical trial is user friendly and adequate and provided in the relevant language it is likely that participation rates are positively influenced [5-8].
In conclusion, understanding a clinical trial, increased levels of valuable information and interaction with study staff helps to reduce fear and improve the likelihood of participation, while sensitivity to the needs and comforts of a patient might improve retention [5, 9]. Medical device manufacturers that implement the concept of patient centricity in clinical trials may therefore have an increased level of patient participation and higher quality study data.
Factory can assist in facilitating patient centricity in your medical device study, whether it is a class I, II or III device. Factory helps you to seek for low thresholds for patient participation, providing you with the required tools. At the same time, Data Managers capture and structure valuable data about enrollment and retention from the very beginning of your clinical trial. Close data monitoring gives insight in main reasons for non-participation in your study or mid-trial drop-out of patients. Since our Data Managers have thorough experience with many different trial designs, we are able to detect possible difficulties in trial design or study-visit scheduling early on. This way, we could help shape and modify study designs, so patients’ needs are better met. Ultimately, this might lead to higher patient satisfaction, increased participation, and better patient retention, which are all important factors attributing to the success of a clinical trial, whilst your own reputation will improve.
By Sabine Aldershof
 Fiminska, Z., Patient centricity: What is it – and why aren’t we there yet?, in Eyeforpharma. 2014: http://social.eyeforpharma.com/patients/patient-centricity-what-it-and-why-arent-we-there-yet.
 The Corporate Reputation of the Medical-Device Industry 2014-15—the Perspective of 463 International, National, Regional and Local Patient Groups (4th edition) 2015: www.patient-view.com.
 Sharma, N.S., Patient centric approach for clinical trials: Current trend and new opportunities. Perspectives in Clinical Research, 2015. 6(3): p. 134-138.
 Mullins, C.D., et al., Patient-centeredness in the design of clinical trials. Value in Health, 2014. 17(4): p. 471-475.
 Walsh, E. and A. Sheridan, Factors affecting patient participation in clinical trials in Ireland: A narrative review. Contemporary Clinical Trials Communications, 2016. 3: p. 23-31.
 Biedrzycki, B.A. Decision making for cancer clinical trial participation: a systematic review. in Oncology nursing forum. 2010.
 Rooney, L.K., et al., Promoting recruitment of minority ethnic groups into research: qualitative study exploring the views of South Asian people with asthma. Journal of Public Health, 2011: p. fdq100.
 Tu, S.P., et al., Clinical trials: Understanding and perceptions of female Chinese‐American cancer patients. Cancer, 2005. 104(S12): p. 2999-3005.
 Capsey L, B.R., In the Patients Shoes from Protocol to Publication-How to Achieve a Patient-Centric Approach to Clinical Trial Design.