The PRA Health Sciences Center for Pediatric Clinical Development’s second annual acknowledgement of World Children’s Day will be celebrated virtually on November 16, 2020. World Children’s Day is celebrated to commemorate the Convention on the Rights of the Child, which is the most widely ratified human rights treaty in history and has helped transform children’s lives around the world. The Convention on the Rights of the Child sets defined parameters to ensure humanity recognizes the equality necessary for children to develop to their full potential. It clearly defines the urgency that a basic quality of life should be the right of all children, rather than a privilege enjoyed by only a few.
PRA Health Sciences is promoting international togetherness and awareness of children worldwide, as well as improving children’s welfare. We will discuss ongoing health disparities and social determinants, diversity (and the lack thereof) in clinical trial participation, inclusion of adolescents in adult clinical trials, clinical trial education of the public and survey results of the “Pediatric Perceptions and Insights” study conducted by the Center for Information and Study on Clinical Research Participation (CISCRP).
Being a member of a racial or ethnic minority, compounded with the lack of awareness and health care access, continue to be a barrier to bringing appropriate clinical trial participation and safe and effective treatments for chronic and debilitating diseases to the pediatric population. Panelists will discuss experienced barriers and how to defy prejudice and encourage diversity. Understanding the populations that suffer most from underrepresentation will lead the clinical trial industry to solutions to positively educate and provide access to clinical trials, leading to safe and effective treatment options.
Inclusion of adolescents in adult clinical trials will increase young patients’ access to safe and effective treatments in a timely manner. Including those between the ages of 12 and 18 years in adult clinical trials will eliminate the extended waiting time for the adult trial results and may help for trial design to support pediatric indications, when warranted, based on preliminary results. Not including adolescents leads to off-label prescribing lacking scientific evidence of safe and effective dosing.
Panel Discussion: Panel to include pediatric/adolescent/young adult participants who have contributed to clinical trials to speak to their health care journey.
Dr. Hemant Malhotra, MD, FRCP, FACP, ECMO, MNAMS, FUICC, FICP, FIMSA, Medical Oncologist, Professor & Head, Department of Medical Oncology, Mahatma Gandhi College Hospital, Jaipur, India
Dr. Hemant Malhotra is Professor & Head of the Department of Medical Oncology at the Sriram Cancer Center of the Mahatma Gandhi College Hospital, Jaipur, India. Dr. Malhotra has more than three decades of treating cancer patients in the state of Rajasthan, and also teaches medical students. Dr. Malhotra is an internationally and nationally recognized medical oncologist, keenly interested in clinical research and has completed more than 40 clinical trials as principal investigator. Dr. Malhotra graduated from the SMS Medical College and later completed fellowships at Tata Memorial Cancer Center in Mumbai and the Cornell Medical and Memorial Sloan Kettering Cancer Centers in New York.
Dr. Nathalie Gaspar, MD, PhD, Paediatric Oncologist, Head of the Adolescent and Young Adult (AYA) Unit & Chair of the AYA Program at Gustave Roussy Cancer Campus, Villejuif, France
Dr. Nathalie Gaspar is a paediatric oncologist at Gustave Roussy Cancer Campus (Villejuif, France), head of the Adolescent and Young Adult (AYA) unit and chair of the AYA program of the institute (SPIAJA program), since 2009. She is in charge of bone sarcomas and cancers with peak incidence in the AYA population, from biology to clinical care. Dr. Gaspar is also paediatric head of the French bone adult and paediatric sarcoma group GROUPOS. She is actively involved in early new drug development in France and in Europe through her participation to the clinical trial committee of the Innovative Therapeutics for Child and Adolescent with Cancer (ITCC) Consortium and through her action as co-chair of the Fostering Age-Inclusive Research (FAIR) Trial Initiative of the multi-stakeholder ACCELERATE platform.
Annick deBruin, BSc, MBA, Senior Director of Research Services, CISCRP, Perceptions and Insights Study, 2020 and Patient Diversity in Clinical Trials
Annick de Bruin is the Senior Director of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions & Insights studies and numerous Patient Advisory Boards. She has more than 20 years of experience conducting primary and secondary research studies in the health care, life sciences and consumer goods industries. She holds an MBA from the Graduate School of Management at Boston University and a Bachelor of Science degree from Bryant University.
(Panelist) Benjamin James, Trustee, Pathfinders Neuromuscular Alliance, United Kingdom
Benjamin James is an MSc (Merit) Science communication graduate from the University of Sheffield who has Duchenne muscular dystrophy (DMD). Benjamin also has a neuroscience (BSc) degree from the University of Nottingham. He is a trustee for Pathfinders Neuromuscular Alliance and has worked with several charities and organisations supporting those with Duchenne, including Action Duchenne, Duchenne UK, DMD Pathfinders and Muscular Dystrophy UK. Benjamin has spoken at a number of conferences, including the EMA conference on “The optimisation of drug development for the benefit of children,” the World Orphan Drug Congress 2019, the International Children Advisory Network (iCAN) Summit in 2018 and at conferences for Action Duchenne. He has been involved in a freelance and advisor capacity with projects aiming to improve the lives of those affected by Duchenne. He pursues music and sailing in his spare time.
(Panelist) Rime Allouche, Member, KIDS France & International Children’s Advisory Network, iCAN, France
Rime Allouche has been a member of KIDS France, a young person’s advisory group, and the International Children’s Advisory Network, iCAN, since 2016. Through KIDS France, she has been advocating to ensure the voice of children and young adults is represented in clinical trials. Rime has also participated in a clinical trial as an adolescent that also included adults. She is currently in university as a pharmacy student in Lyon and is very interested in every aspect of clinical research.
(Panelist) Max Williamson, National Cancer Research Institute, United Kingdom
Max Williamson is a young cancer patient from the UK, who was diagnosed with a germ cell tumour at aged 15. For the past four years, Max has worked closely within the UK cancer patient advocacy community to ensure young people are represented, along with adult and childhood cancer. This includes being a patient advocate on the Teenage and Young Adult Cancer research group of the UK’s National Cancer Research Institute, and similar groups within the National Institute of Health Research and Cancer Research UK. Max joined the ACCELERATE FAIR Trials group in 2018, working with groups across Europe to ensure young people are not excluded from paediatric or adult research.
Who Should Attend?
- Regulatory Affairs
- Scientific Affairs
- Risk Management
- Project Management
- Clinical Research
- Medical Affairs
- Clinical Affairs
- Research and Development
- Clinical Operations
- Health Care Providers
- Advocacy Groups and Members
- Anyone Interested in Pediatric Oncology
PRA Health Sciences
PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results. We offer exceptional experience across all phases and therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to a pioneering embedded model.
With 16,000+ employees covering 90+ countries, we bolster an impressive global presence with keen local insights. Our project teams harness their understanding of local regulations, standards of care and cultural customs to effectively align our approaches with each study’s unique goals.
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