It was a familiar scenario: A rare disease area of oncology. A new drug candidate. A desire to assess efficacy as safely and quickly as possible, so that if successful, a new therapy could get approved and change lives. But this desire could have been tempered by reality: the trial was going to be challenging and slow…
For the clinical research industry, technological tools improve trial continuity, and generate data that helps power more robust monitoring of safety and quality. They can also be a natural fit for patients. IQVIA also sees study participants liking the direct shipment of medicines, telehealth interactions and at-home visits. In the COVID era and beyond, designing more trials with these kinds of technology-enabled strategies is going to help more people by lowering barriers to participation, and speeding the development of new medicines.
Diverse technology solutions, like patient telehealth visits, accessing electronic medical records (EMRs) or remote source data verification, can generate vast amounts of data. As the clinical research industry evolves towards its next “new normal” with a higher baseline level of remote monitoring, IQVIA is considering the implications of increasing data access. Are we ready?
We all had a flurry of unprecedented activity. We were assessing risks to patients and data, and putting in place mitigation strategies to preserve continuity of the studies.” Those strategies involved thousands of amendments to protocols, adapting to sudden changes that impacted patients and sites around the world.
A key pillar in the COVID-19 battle is the rapid development of a safe and effective vaccine. As vaccine R&D shifted into gear and then accelerated throughout 2020, with a rapidly growing number of candidates, platforms and manufacturers, it appeared that a bottleneck in this race could actually be the ability to enroll participants.
“There’s a global sense of urgency,” says Jamie Macdonald, CEO of Parexel, of the collaboration between stakeholders to accelerate development. One key focus for Macdonald is the lengthy process of trials, and compressing that “dead space” to shorten timelines, improve efficiency and quality.
“The pandemic has changed everything about the pace of our innovation and our focus,” says Peyton Howell, EVP and Chief Commercial & Strategy Officer at Parexel. There used to be lots of caution around using real-world data and evidence, but this year has illustrated the need for new paradigms.
For Dr. Sy Pretorius, Parexel’s Chief Medical & Scientific Officer, COVID-19 has been a catalyst. The pandemic has accelerated innovations that make it easier for patients to participate and for sponsors to conduct research. Parexel has seen increases in decentralized trials and remote monitoring, where study designs were adapted amidst the pandemic.
New medicines are at the core of clinical research. Historically in clinical research, these experimental medicines move from a warehouse to a…
In August 2020, Syneos Health CEO Alistair Macdonald reflected on the COVID-19 crisis to date. Read Part 1 of the conversation. In…
Doug Peddicord, ACRO’s Executive Director, introduces the series and sheds light on the importance of CROs and technology companies in spearheading clinical innovation through COVID-19 and beyond.
In August 2020, Syneos Health CEO and ACRO Board Chair Alistair Macdonald reflected on the COVID-19 crisis to date. This conversation has been edited lightly for clarity.
September 1, 2020 – (Washington, DC) – Clinical trial activities have traditionally centered around trial sites where patients travel for participation. This…
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Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Alistair…
On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development…
Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to…
A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient…
On July 17, 2019, under cooperative agreement with the FDA, the Duke-Margolis Center for Health Policy (Duke Margolis) held a public workshop. The event, titled Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations, aimed to identify opportunities to improve Risk Based Monitoring (RBM) implementation and solicit stakeholder input on the challenges, barriers, and enablers that impact the successful adoption of RBM.