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Information about 11th Annual Patient Recruitment and Retention Summit

Heidi  MÜLLER

Director, Patient Engagement Strategy
The Janssen Pharmaceutical Companies of Johnson & Johnson

Questions For Heidi Müller

What do you see as the most critical part of patient retention?

The relationship between the study participant and the site staff is of significant value for the patient who seeks support and understanding when both are managing their disease and their participation in the clinical trial. The study site coordinator/study nurse plays a pivotal role in this relationship, and as such the retention.

How is the new regulation ECTR effecting the clinical trials in Europe?

By means of the regulation, the EU intends to limit the regulatory authority at national level. Shorter approval timelines are expected. With this the European Union aims to make Europe more attractive for study placement.

How to make sure to recruit the right patient? How to choose the right country?

The ideal study patient is someone who is aware of what clinical research entails and what the benefits are for the society and potentially for the individual participant, before a trial is offered to them. These individuals have bought in to the idea of clinical trial participation before they face a health issue where trial participation is proposed. I expect this knowledge positively impacts the trial participant’s belief that this is the right thing to do, and as such also their engagement in the trial.
The right country is identified by a balanced selection based on epidemiology data, regulatory framework and timelines. In addition, the in-country monitoring team will significantly contribute to the local trial success.

What is the best approach to digitalisation in clinical trials?

Focus on simplicity and a great communication network: digital applications should be integrated with the participant’s smartphone. The site staff and the helpdesk should be able to answer all the questions immediately.

What is the most challenging aspect of patient recruitment?

Designing a recruitable and manageable protocol, the latter both from the Patient and Site perspective.

Heidi Müller, Director Patient Engagement Strategy at the Janssen Pharmaceutical Companies of Johnson & Johnson, is for over 25 years a Clinical Research professional with passion for Patients, People and Partnerships. She has gained local and global clinical operations experience both at the CRO and pharma side, as well as 8 years of nursing expertise.

Dr.Wolfgang  EGLMEIER

Head Centre for Clinical Trials
Witten/ Herdecke University Germany

Questions For Dr. Wolfgang Eglmeier

What do you see as most critical part of patient retention?

To keep the patients motivated to stay on the trial – the burden to participate have to be well balanced with the benefits for the patients

How is the new regulation ECTR effecting the clinical trials in Europe?

More transparency will come to allow patients to be better informed.

How to make sure to recruit the right patient? How to choose the right country?

By proper feasibility with “real investigators”, not just KOLs – and by involvement of patient support groups very early, to adapt the protocol to the reality.

What is the best approach to digitalization in clinical trials?

Obtaining data directly from the patients (ePRO) and providing them with feedback and guidance – but please be aware, not to “provide an uncertified medical device”

What is the most challenging aspect of patient recruitment?

To run studies, there „real patients” fit in and not kust „ideal patients”

Dr. Wolfgang Eglmeier studied biology. He obtained a PhD in neuroscience in 1988. Wolfgang is working in the area of clinical development since 1988. He started as a CRA, monitoring studies in central and Eastern Europe. In the early 90s he was with a software company, which developed data management and remote data entry software. Since 1993 he holds several management positions, mainly on a European level, in the pharmaceutical industry, biotech companies and CROs (e.g. Head Clinical Research Central Europe for Novo Nordisk, Global Head Clinical Development for Paion, Head Clinical Operations Germany for Grunenthal). He has about 30 years of experience in all aspects of clinical development, like project and study planning, performing and management of trials, data management and reporting.

Maarten  BOOMSMA

Clinical Study Director
Sanofi

Questions For Maarten Boomsma

What do you see as most critical part of patient retention?

Long term prophylactic trials have historically proven to be at risk of low retention. Surrogate endpoints are not accepted. Therefore a large number of patients have to remain in blinded studies for an extended period of time. As a sponsor, you may face many challenges along the way. Proceeding insights in the standard of care, new treatment options e.g. commercially available medication of a similar class. The key question is; how to keep your patient (and investigator) motivated to keep supporting the study?

How is the new regulation ECTR effecting the clinical trials in Europe?

Hopefully this will facilitate a high quality but speedy ethical approval of clinical trials across Europe, but I’m not an expert in identifying all risks and opportunities of ECTR.

How to make sure to recruit the right patient? How to choose the right country?

It is crucial to reach out to (potential) investigators and, if possible, patient representatives in a concept phase of the study. This may cost some time initially, but I’m sure the payoff will come later on. If you are able to build in this sound boarding process during the time challenged conceptual phase of the study, you are truly able to integrate their feedback into your protocol and improve it, whereas if you do this later on, you are forced to come up with merely a coping strategy. With regard to country selection, when reaching out to potential investigators they will provide invaluable information about the feasibility in each participating country and site. Off course this needs to be supported by historical performance of sites/countries.

What is the most challenging aspect of patient recruitment and how can digitalization help?

During feasibility investigators provide information related to the number of potential feasible patients mainly on estimations based upon experience. Performing a comprehensive chart review (or database review) is time consuming and in this phase it is far from certain the site, or even the country will be selected. Once the site is initiated, nearly always the number of potential eligible patient is considerably reduced. The ability to review electronic health record centrally may provide real time and reliable info related to the number of potentially eligible patients per participating site, and the impact of individual inclusion/exclusion criteria. Also at a site level, this will surely facilitate identification of potential candidates and improve reliable recruitment projections in the near future.

Maarten Boomsma has been working for various pharmaceutical companies with different roles after finishing medical school and obtaining a PhD in clinical immunology in Groningen, the Netherlands. Currently Maarten works in the role of Clinical Research Director in the Immunology & Inflammation medical operations department within Sanofi. In this role, Maarten is part of a global study team and involved in Phase 2-3 clinical research trial in protocol development, trial conduct, and wrap up (e.g. preparation of Clinical Study Report) after completion. In his spare time Maarten enjoys going out with his family and outdoor sports, like hiking and mountain biking.

Rocco  CRESCENZO

Ex. Global Clinical Lead
Pfizer

Questions For Rocco Crescenzo

What do you see as most critical part of patient retention?

Maintaining interest and a feeling of contribution.

How is the new regulation ECTR effecting the clinical trials in Europe?

The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database. Overall, this should have minimal effect on patient retention and recruitment. It may improve safety reporting and thus overall safety for the patients which may intern assist in retention but I do not see a major effect on retention.

How to make sure to recruit the right patient? How to choose the right country?

The choice of patients is always difficult due to the multifactorial nature of recruitment. The most important aspects of recruitment are the investigator’s understanding of the trial and the patients motivation.
Similarly, choosing the appropriate country is complex. You need to choose countries where the disease under study has a high enough incidence to warrant the effort. Also, the nation must have an existing infrastructure to support the trial.

What is the best approach to digitalization in clinical trials?

There is no best approach.

What is the most challenging aspect of patient recruitment?

Convincing the patient that the trial will provide benefit for him/her and society in general.

Rocco Crescenzo is a board certified medical oncologist/hematologist and Fellow of the American College of Osteopathic Internists, with over 20 years of clinical experience and research in both academia and industry. Since December of 2008, Rocco has been working in the pharmaceutical industry. During these past ten years, his experience included study design, protocol development, study execution, data analysis, medical governance, strategy and tactics for drug development, and drafting a clinical development plan.

Dr.Domenico  MERANTE

VP Global Clinical Development, Global Pharmaceutical Physician
Sosei Heptares

Questions For Dr Domenico Merante

What do you see as most critical part of patient retention?

Patient motivation, improvement of symptoms, good tolerability of the newly investigated drugs, feasibility of study design and schedule and procedures, willingness to stay until the end of the study.

How is the new regulation ECTR effecting the clinical trials in Europe?

The ECTR aims to accelerate the application process by simplifying and harmonizing the administrative requirements for multicenter CTs across the EU and it is immediately applicable in all MS, without a need for transposition into the individual legislation. A single electronic application dossier, submitted through the EU portal provided by the European Medicine Agency (EMA) is its most innovative feature. CTs assessment will occur in a two-step process: the first, for evaluating the scientific rational, will be performed by a Reporting Member State (RMS) chosen by the sponsor, and will be binding on all MS; the second, conducted at a national level by each MS, will evaluate local and ethical aspects. ECTR provides an accurate time schedule for every step and provides for sanctions for non-compliant MS. This coordinated approach will lead to a decision that applies to all MS, replacing single national approvals.

How to make sure to recruit the right patient? How to choose the right country?

Due Diligence activity is strictly necessary for the scope of utilizing the most appropriate countries and the correct patients. These activities are monitored by the sponsor directly and by the contract research organization working in the clinical program.

What is the best approach to digitalization in clinical trials?

Digitalization leads to better efficiency, better insights, and better patient outcomes in clinical trials—and how those who invest now will lead the industry. New technologies enable transformation in three clinical areas: trial design; trial start-up and trial conduct & close out.

What is the most challenging aspect of patient recruitment?

The most challenging aspect of patient recruitment is linked with feasibility of appropriate protocol eligibility criteria and to reduce the impact of screening failures.

Dr Domenico Merante graduated as MD at the School of Medicine of Pisa University in 1988 and specialized in endocrinology and diabetes at the same University of Pisa and working at the diabetes center of the main St. Chiara hospital of Pisa. Dr Merante combines also 15 years of clinical practice experience as emergency doctor in the NHS Italy and in the Italy Navy as Chief Medical Officer of Nave Ammiraglio Magnaghi. As pharmaceutical physician Dr Merante has so far matured 25 years of clinical development and clinical positioning experience in Italy, US and UK working across a broad range of therapeutic areas: diabetes, endocrinology, cardiovascular, dyslipidemia, hypertension, diabetic retinopathy and macular edema, neuropathy, diabetic wounds, nephropathy and vasculopathy. In addition, whilst working at Daiichi Sankyo Development UK for nearly 10 years and at Shionogi Europe UK for less than two years, Dr Merante has developed global clinical development experience with several pain conditions such as painful diabetic neuropathy (phase 2) , fibromyalgia (phase 3) and post-surgical pain (phase 2) and in phase 3 studies with novel antibiotics, antivirals, in severe thrombocytopenia associated to chronic liver diseases, in phase 1 in Idiopathic Pulmonary Fibrosis and in oncology area. Dr Merante focus is on patient safety and on patient-centric global initiatives and clinical development plans, management and execution. Science-driven, with an innovative, global and creative mind-set, Dr Merante is a prolific medical writer with to date over 80 publications amongst full papers, abstracts and presentations as first author or as co-author.

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