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Hottest information about 12th Annual Patient Recruitment and Retention Summit

15 OCTOBER 2019

BIRGITTE CLAUDIUS

MD, Director,
Head Clinical Operations
Novo Nordisk

3 Questions For Birgitte Claudius

What do you see as the biggest challenge in Patient Recruitment and Retention nowadays?

The WIIFM is sometimes lacking. If they live in a health care system where health care is free, they have a lot of hassle by being in a trial but not necessarily extra benefits – in their eyes. The incentive needs to be there.
Secondly, the number/complexity of assessments are often high which is a burden.
Thirdly, there are often requirements of long-term safety, follow-up, effect of drug, hard outcomes, etc., which make the trial very long. To commit to a trial with site visits and treatment for a long time is very challenging.

Which recruitment strategies do you consider as the most effective?

The best strategy is to create a relationship with the patient, hence the site staff are key people. They are the ones meeting the patient, seeing their needs and fears, having to train and educate, talk and listen to the patients. A good study nurse is what makes the difference!!!

How to improve patient and site engagement?

• See above
• Patient-centric activities and training
• Make sure they understand ‘WHY’
• Address and fulfil WIIFM for both patient and site staff
*(WIIFM: What’s in it for me)

Birgitte Claudius is a Medical Doctor by training and has after years of clinical work and research been working in the pharma industry – for almost 20 years. This experience covers in-depth competencies from Medical Affairs, Clinical Development and Clinical Operations. The past 13 years she has been working in the headquarter of Novo Nordisk AS with development programmes within Diabetes, Obesity and Cardiovascular diseases taken several drugs from first phase II trial to submission of the NDA/IND. As part of this trial journey dedicated strategy for and execution of recruitment and retention tools/activities have been key to ensure sufficient data volume and quality. Hence much focus and many learning’s have been collected in her department. One recent area of expertise has been to conduct excellent virtual external meetings as a tool to reach sites and interact with our key customers.

24 SEPTEMBER 2019

TINA BORNEMANN

Clinical Study Patient Engagement Manager
UCB Biosciences GmbH

3 Questions For Tina Bornemann

What do you see as the biggest challenge in Patient Recruitment and Retention nowadays?

One challenge I see is that the clinical research space is getting more crowded every year, with more and more similar studies running in parallel. Pharmaceutical companies compete against each other for which study is the most attractive for sites and patients to participate in.

Another challenge that also presents itself as an opportunity is the ever-changing technological environment. Pharma and our many stakeholders need to have the ability to fully utilise options such as decentralised clinical studies, real-world data, electronic health records, genotyping, blockchain, and the ongoing evolution of social media, as just a few examples.

Which recruitment strategies do you consider as the most effective?

Working with patients and tailoring strategies to the study’s patient population and specific country and region are hugely important. Partnering with patients and patient advocacy groups early along the clinical development continuum, especially in the rare disease space, is paramount to designing successful studies. This, in turn, ties into a developed social media outreach strategy that can serve as a nice complement to site-based enrolment efforts.

Personal contact with the sponsor is sometimes lacking for pharma companies performing clinical studies via a CRO. Sites very much appreciate a direct link with the company. This can motivate sites to enrol patients in studies, and also provide value insights into bottlenecks and hurdles related to study enrolment.

Furthermore, I still also consider well-made site-facing and patient-facing materials extremely important, because a well-informed patient who understands the study is more likely to complete the study than the one who didn’t fully grasp the concept of the trial.

How to improve patient and site engagement?

Co-creation with patients! So much to speak about there, but whether within study design, protocol development or at other clinical development stages, having the input of the patient is critical to clinical research moving forward. As mentioned previously, a direct link between study site and the sponsor can be an important improvement in engaging and motivating sites. Furthermore, virtual and/or remote clinical studies is a field that UCB is exploring more and more, and it can have a significantly positive effect on reducing patient burden.

As a Clinical Study Patient Engagement Manager for UCB’s Global Clinical Sciences & Operations, Tina Bornemann is the member of a strong global team that provides oversight for patient recruitment and engagement efforts across UCB’s clinical studies. Tina has 16 years of experience in clinical development, with a profound background in Clinical Project Management and a passion for all things Patient Engagement.

24 SEPTEMBER 2019

RICHARD  STEPHENS

Patient Advocate

3 Questions For Richard Stephens

What do you see as the biggest challenge in Patient Recruitment and Retention nowadays?

I see two challenges. The first is that we are not yet approaching enough patients. In the UK we have 300,000 newly diagnosed patients every year in our National Health Service. Roughly 35% of all cancer patients participate in some form of research, and 23% join clinical studies, all of which is very good. Yet, we aren’t approaching nearly two-thirds of patients to ask if they wish to participate in trials or tissue donation. We have very high acceptance rates when we do ask (66% for trials), but too often we aren’t asking.

The next challenge is broader, and it is all about trust. We, patients, need to know we can trust the systems; that all studies will be published openly, that our data and tissue is held securely and used anonymised, and that our samples are being put to good use for ethically approved research and not mad scientists playing with their test tubes and petri dishes. And we don’t mind if industry makes a fair profit – but we do not expect companies to rip off health systems when it is our fellow patients somewhere who have contributed to the testing of the products.

Which recruitment strategies do you consider as the most effective?

It depends on circumstance and culture. In the UK, we have our national health service, and the best recruitment strategy for studies in acute conditions will always involve the treating clinicians or our nurses. But for chronic conditions, the recommendations of patient groups often carry as much weight – the influence of one’s peers is always powerful. But I think in the end it does depend on the disease or the condition, on the study methodology (just how many biopsies do you really need?), and on the health system. After all, wherever we are, we enter trials because we are ill, not because we have a burning desire to boost the share value of Pharma plc, but we do want access to what we think are the best medicines available to us. In the UK and elsewhere in Europe too, the most effective recruitment strategies are often those that have had patients helping to design them. And in my experience, that’s even better applies in retention strategies, especially where retention may be a known challenge.
Lastly, if you are trying to improve patient engagement with the industry, please accept that it will take time, and for every three steps forwards, there may be as well two steps backwards – or at least sideways!

How to improve patient and site engagement?

Make it easy for people to join and to stay in studies; emphasise the advantages of being in a study – the Cancer Patient Experience Survey in England shows that cancer patients participating in trials report higher levels of satisfaction with their overall care. Get patient groups on board – they can publicise both the study itself and the benefits of research in general; again, it’s the peer information that helps reinforce other trusted sources (where they exist). As for the sites, that’s a bit harder. But why not to have Patient Research Ambassadors or Champions based in hospitals or prominent in online fora? We are trying it in the UK, along with the NIHR acting a broker between industry and patient groups.
In the end, what we need to do is to create a culture where taking part in research is a routine part of the patient experience; not just trials and studies, but data and real-world evidence, all in a spirit of genuine collaboration. Let’s make the world better and make a better world too. There’s a challenge!

Richard Stephens is a survivor of two cancers, a heart emergency, and continued co-morbidities and late effects. He has participated in four interventional studies and nine others.

Richard was the patient representative who co-authored the (English) Cancer Strategy 2015-2020, was a founder member of the AllTrials campaign and useMYdata movement, and is co-Editor-in-Chief of the Journal of Research Involvement and Engagement. He has worked with industry (AstraZeneca, Pfizer, Norgene et al) and with patient groups in Canada and Europe.

A veteran of 19 years as a patient advocate, Richard latterly Chaired the NCRI’s Consumer Forum and now Chairs BBMRI-ERIC’s Stakeholder Forum. He sits on strategic groups for Genomics England, Cancer Research UK, NHS England, NIHR NDC-HSC, PHE-NCRAS, CQC, MRC CTU, EHIC, ECOS, and the ABPI. In his spare time he is learning to speak acronym.

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