Is education the key to improving adherence?
Rebecca Aris interviews Elisabetta Verdun di Cantogno
Merck Serono S.A
Patient recruitment for clinical trials can present numerous challenges and having participated in many trials Elisabetta Verdun di Cantogno knows this only too well. On the run up to her speaking engagement at the ‘Best Practice in Phase IV Clinical &, Observational Research’ Elisabetta shares with us her insight into steps to successful patient recruitment for clinical trials and offers her wealth of knowledge in non-adherence.
Throughout her career she has noted many trends in patient adherence and she notes here the factors she considers to be important with emphasis on physician related causes. Is it time we offer more support to the physician to encourage patient adherence?
To listen to the full interview, please click on the play button below, with a shortened transcript of some edited highlights shown in print below.
RA: Hello Elisabetta, Could you please start by telling me about your background and what your current role entails?
EV: I am a neurologist with 18 years of clinical and drug development experience, specifically in neurodegenerative diseases, including some orphan diseases like myasthenia gravis and polyneuropathy. I have participated in many clinical trials and at present I am working for Merck Serono, as medical director in the global clinical development unit. I am responsible for several projects, and I also support my marketing colleagues in developing marketing strategies, health economic strategies, and also supporting to drive the publication plans.
“We have met many problems with patient recruitment, it is one of the single most important issues in the development of a clinical trial today.”
RA: Patient recruitment for clinical trials can be a challenge, how do you think we can help to overcome these challenges?
EV: We have met many problems with patient recruitment, it is one of the single most important issues in the development of a clinical trial today. I think we can help overcome these challenges by adhering with a multi-phase process. The first phase, prior to starting the trial is to:-
• Focus on optimising the provisions for the clinical trial protocol.
• Select few objectives and endpoints that are scientifically and clinically relevant.
• Collaborate with the steering committee and key opinion leaders from the beginning of the development of your project.
• Target your patient population well .
• Write a clinical trial protocol in simple and plain English.
• Perform a good feasibility study, to identify the investigators who have access to the target population, and can have also the appropriate resources and time to develop the study.
• Budget the investigator’s fees at a fair market value and have a clear commitment from the investigator for the duration of the trial. When we finalise the contractual agreement with the investigator we need to have clear specifications about the timelines and number of patients each single centre needs to recruit in each study.
The second phase is considering what is important during the recruitment period, which is to create good communication between the responsible physician and the investigator to clarify questions about the patient selection in the study. We also need to provide clear materials for to the physician to give to the patient to explain the study and what is expected of the patient during the study. The physician should also be provided with access to an internet-based system that evaluates the status of recruitment at other sites as this is a big motivator for the investigator.
“Non-adherence can impact or damage the reimbursement policy for a medicine…”
In phase three we encourage patient retention. We do this by:-
• Motivating the investigator and reminding him of what needs to be achieved during follow up of the patient.
• Providing the investigator and the patient clear objectives related to the study.
• Sharing results of the study with the investigator.
• Involving the investigator in the publication or in the presentation of study data.
• Supporting the investigator to facilitate the patient visit.
• Providing the physician with some support material.
RA: What problems does non-adherence present to the industry?
EV: Quite simply, when patients don’t take their treatment it cannot work, and we see this in normal clinical practice. For this reason the perception from the physician and the patient is skewed regarding the drug efficacy. This can alter the normal data for the registration of the drug. In each country we locally monitor different diseases and their treatments through registries. Non-adherence can impact or damage the reimbursement policy for a medicine, because the local authorities normally refer to the local registry data.
“There are several reasons for patients not to adhere to their treatment, but I think the most important reason is physician related.”
RA: What would you consider to be the main causes of non-adherence?
EV: There are several reasons for patients not to adhere to their treatment, but I think the most important reason is physician related. Physicians don’t have the time to educate the patient. In addition, Physicians don’t receive training on how to train the patient or how to monitor patient adherence. Most physicians are alone when managing the patient and therefore don’t receive the support of a multi-functional team.
Other important causes are patient related and link to a lack of education. The patient receives inadequate education from the physician and they don’ always understand the disease or the treatment instructions or objectives very well. They may need further instruction on how to include the treatment in their routine and their daily life. However, a lot of patients simply forget to take their medication.
Other key important factors are related to the treatment, its tolerability and the complexity of the treatment regimen. Also if the patient receives several treatments, previous treatment failure provide less motivation to be compliant when starting a new treatment.
Around the patient we have the physician, other members of a healthcare professional team, the specialist, the family and the patient association. All these people are key players in the management of the patient and the the disease, and also to support the patient in adhering to treatment. They can all provide support as part of the 360 degree management of the patient.
RA: How do you think we can really measure patient adherence?
EV: There are direct systems such as patient reporting and drug accountability. However, we use in more interventional studies, electronic monitoring, and more direct evaluation such as chemical markers. Chemical markers are not available for all treatments but are very useful when validated for a specific disease. They also provide a huge motivation for the patient, because the patient and physician follow up to understand if the patient is responding and adhering to the treatment. The most objective evaluation of adherence is the use of electronic monitoring. New devices for injectable medicine are available but need to be further studied to see if they are patient-friendly and can be used for different treatments. I think another important measure in encouraging patients to adhere to treatments is technology, such as telemedicine, to remind the patient to take the drug.
“…it’s very clear that there’s a particular problem with non-adherence in patients with chronic diseases.“
RA: In what disease areas have you noticed non-adherence to be more of a problem, and why do you think that is?
EV: In my clinical experience and therapeutic area, it’s very clear that there’s a particular problem with non-adherence in patients with chronic diseases. In patients prescribed chronic treatment that have some degree of chronic disability progression there are more problems with compliance and in persisting with treatment. In these cases it is hard to identify the real problem especially in diseases such as diabetes, hypertension and neurodegenerative diseases. The patient forgetting to take the treatment is one of the most common reasons for non-adherence, but another reason is the patient’s changing attitude.
RA: Well Elisabetta many thanks for your time, and thank you for your insights.
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About the interviewee:
Dr Elisabetta Verdun di Cantogno is the Global Medical Director, Neurodegenerative diseases, at Merck Serono S.A. Switzerland. She can be emailed at Elisabetta.Verdun.Di.Cantogno@merckgroup.com.
What factors do you think are important in encouraging patient adherence?