The current barriers to success of clinical trials include issues like difficulties in recruitment, low adherence to clinical trial protocols, high drop-out rates, and costly resubmission of protocols, all of which have a negative impact on a sponsor’s timeline and budget.
Engaging with patients – and their caregivers and advocates – during the planning and execution of clinical trials is crucial. When patients are involved in the clinical development plan and creation of the trial protocol and are encouraged to provide in-trial feedback, they are more likely to stay in the trial, understand their responsibilities, and adhere to the protocol requirements. Working in partnership with patients can ensure impactful clinical benefit of treatments that address important unmet patient needs prioritized from the patient’s perspective.
In recent years, pharma and MedTech companies have become much more conscious of the role of patients in product development, including the potential of including their input in the clinical research stage. Patient, caregiver, and advocate insights can help sponsors and researchers plan and execute accessible clinical trials with more feasible protocols, improved inclusion/exclusion criteria, and meaningful endpoints, ideally yielding completed trials with more impactful results while also saving time and financial resources.
However, lack of awareness, resources, and time to participate in patient engagement activities can negatively affect a company’s ability to benefit from patient input.
How do sponsors and researchers engage patients in the development lifecycle and make the most of their involvement in clinical trials?
In this webinar, our experts will review the range of tools that enable patient engagement during the clinical research stage of drug development.
During this webinar you will learn:
- How to properly inform patients who are considering participation in a clinical trial
- How to properly include patient feedback in creating primary and secondary endpoints in a trial
- How to investigate that clinical protocols address all patients’ symptoms in addition of addressing the primary need
- How to co-create a protocol with patients and/or review it with them and incorporate their feedback
- How to keep patients engaged after the trial ends for future data collection
The goal of every patient and their families is to have access to successful treatments that fully address their medical needs, with minimal invasion of their lives (time, pain, anxiety etc.). Therefore, patients should be working side by side with industry and regulators to make sure that new products indeed satisfy the above characteristics.
Speakers
Giulia Pierini, Associate Director, Patient Engagement, Alira Health (Moderator)
Giulia Pierini joined Alira Health in 2018 after four years of experience in marketing and sales for big pharma and two years as a researcher in the Department of Cellular Biotechnology & Hematology of the University of Rome “La Sapienza”.
She gained her knowledge about the pharmaceutical industry at Johnson & Johnson and Bristol Myers Squibb, working in the neurosurgery, neurovascular and cranio-maxilla facial fields, mainly in the operation room in direct contact with surgeons and patients.
She then transitioned to consulting and she has been involved in 20+ strategy projects in the pharmaceutical and medical device industry related to multiple therapeutic areas, including R&D, diagnostic, dialysis, respiratory and oncology.
Having worked in the operation room for several years, she is a fierce supporter of the importance of the impact of business functions on patients’ lives.
Message Presenter
Annabel de Maria, Chief Patient Officer, Alira Health
An industry pioneer in patient engagement, Annabel de Maria started her career in 1998 as part of the communications team at Pharmacia & Upjohn that launched Celebrex, Detrusitol and Xalatan in Spain.
Prior to joining Alira Health in 2020, Annabel was Head of Media Relations Europe at Nestlé Purina and before that was Head of Corporate Communications at Almirall. Her previous experience includes Patient Brand Manager for Viagra at Pfizer and for Levitra at Bayer, External Communications Lead for Novartis Spain and Patient Strategy Consultant for Lucentis, Pradaxa (Global Brand Team) and Champix (European Brand Team).
Annabel teaches patient engagement at the University of Bocconi, and she is the patient representative for the EULAR working group on autoinflammatory diseases. She has published two posters at ISPOR on the involvement of patients in the HTA process and one at EAACI on unmet patient needs in type 2 inflammatory diseases.
Message Presenter
Dr. Giacomo Basadonna, MD, Chief Medical Officer, Head of Global Medical Strategy, Alira Health
With a background in transplant, general surgery and immunology, Dr. Giacomo Basadonna has worked closely with the NIAID/NIH for over 25 years, designing and executing clinical trials.
Dr. Basadonna is currently a Professor of Surgery at the University of Massachusetts Medical School, and a member of 23 national committees, three hospital committees and 14 professional societies.
Prior to joining Alira Health, Dr. Basadonna held Chief Medical Officer positions at global companies, including Z-Medica, and his previous hospital appointments include UC Davis Medical Center, Yale New Haven Hospital and UMass Memorial Hospital.
Over his career, he has secured 16 grants from businesses and governments, and his publications include over 80 abstracts, 13 limited dissertations and over 100 publications in peer-reviewed journals. He is a sought-after speaker, presenting at over 80 major conferences.
Dr. Basadonna holds an MD and PhD from the University of Milan.
Message PresenterWho Should Attend?
This webinar benefits Chief Scientific Officers, Heads of Clinical and Clinical Managers, among others, from pharma and medtech companies.
What You Will Learn
Attendees will learn:
- How to properly inform patients who are considering participation in a clinical trial
- How to properly include patient feedback in creating primary and secondary endpoints in a trial
- How to ensure that clinical protocols address all patients’ symptoms in addition to addressing the primary need
- How to co-create a protocol with patients and/or review it with them and incorporate their feedback
- How to keep patients engaged after the trial ends for future data collection
Xtalks Partner
Alira Health
Alira Health is a global healthcare firm whose mission is to humanize healthcare and life sciences in partnership with patients. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle, including clinical operations, real-world evidence, and patient-centric technology offerings.
Our integrated and multidisciplinary team of over 800 scientists, strategists, economists, clinicians, and biostatisticians collaborate across our North American, European, and Asian offices and advise 80% of the top 50 MedTech companies and 75% of the top 50 Pharma companies.
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