Clinical Trials: Against All Odds
A Janssen leader’s reflections on 'Clinical Trials: Against All Odds'
Clinical trials are a hugely complex enterprise that depend on the expertise, organization and dedication of many scientists, engineers, clinicians, project managers and their teams, strong collaboration with doctors, nurses, hospitals and their clinical teams and collaborations with governments and health care regulators. Most importantly, clinical trials rely on the participation of volunteers, patients, caregivers and we hope these trials will lead to the advancement of new medicines. What we do is complex but is also an amazing opportunity to make a difference in the healthcare for humanity.
This Clinical Trial Awareness Week we focus on clinical trials as part of the drug development process and reflect on how the advancement of new medicines through this process is made possible thanks to collaboration between these important contributors and stakeholders, “against the odds”.
"I have participated in two separate clinical trials and my motivation in both cases was to help find better treatments for patients." - Jackie, Clinical Trial Participant
The COVID pandemic presented many additional challenges for the clinical trial process. I have been impressed by the ingenuity, flexibility and resilience shown by all clinical trial stakeholders, both inside pharmaceutical companies, and also through clinical trial sites to develop new ways of working and approaches to ensure the continuity of care and follow-up for participants, even during the height of the pandemic.
"In extreme periods of difficulties, such as the covid-19 pandemic, forces were united, seeking new methods, through video consultations, telephone and other means offered ... to improve the [clinical trial] patient's treatment conditions." - Mayra Cristina Gomes Lotierzo, Study Co-ordinator from Nucleo de Pesquisa São Camilo, Brazil
Clinical trial participants typically visit clinical sites to receive study medication and to have study assessments performed. Before the pandemic, the Janssen team was using several capabilities and technologies to make clinical trials more accessible and convenient for participants by helping to integrate the clinical trial into everyday life. The pandemic severely curtailed the movement of people, and the ability of trial participants to visit trial sites. We were able in many cases to accelerate solutions like home healthcare nurses, direct to participant study medication shipment and telemedicine to ensure trial continuity. What we have learned has changed the future of clinical trials at Janssen – especially as we look ahead!
Patients are at the heart of our mission, and we strive to embed the patient voice into everything that we do. This Clinical Trial Awareness Week, you will hear from Jackie, a clinical trial participant and a member of Janssen’s Immunology Global Community Advisory Board. Jackie is one of 14,000 patients and caregivers who have shared their voice with Janssen so that we can design research protocols and clinical trials that are grounded in the everyday reality of patients.
"The pandemic’s impact was universal, but it didn’t affect everyone in the same way. Like many other health challenges, COVID-19 has disproportionately impacted some communities." - Denise Bronner, Director; Diversity, Equity and Inclusion in Clinical Trials, Janssen Pharmaceuticals, Inc.
At Janssen, we are deeply committed to championing diversity, equity and inclusion to support all patients’ unique needs, especially those from underserved and underrepresented communities. We invite you to learn more about our work by visiting ResesearchIncludesMe.com.
On behalf of Janssen, I would like to end by expressing our deepest gratitude to the people who make clinical trials and the advancement of new medicines possible. Together we aspire to make disease a thing of the past and together we advance, against all odds.
May 17, 2022
Peter Ronco is Head, Global Development, Janssen R&D. In this role he is responsible for leading the Global Development organization in delivering the portfolio on time, within budget, and with robust quality, while continuously working to optimize efficiency and improve the patient and investigator experience in Janssen clinical studies, through all phases in the global development process. Prior to joining Janssen in 2017, Peter was the Senior Vice President of Global Clinical Operations for a global pharmaceutical company where he spent 14 years holding positions of increasing leadership scope in Medical Affairs, Regulatory Operations and R&D Operations. He also serves on the Transcelerate Biopharmaceutical Board of Directors.