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Hottest information about 11th Annual Patient Recruitment and Retention Summit

4 OCTOBER 2018

MAARTEN BOOMSMA

Clinical Study Director
Sanofi

4 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

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.

4 OCTOBER 2018

ROCCO CRESCENZO

Ex. Global Clinical Lead
Pfizer

5 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.

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