The Post-Pandemic CRO Landscape

None is inconsequential: advancing digital technology, globalization of clinical trials, changes in clinical trial design, the inflow of private equity dollars, fewer sponsors lost to mergers and acquisitions, more CROs, the costs of clinical trials, precision medicine, lack of available talent, and-an under the radar trend-the continuing challenges of chronic disease. A 2020 report called them a "primary factor" in the growth of global CRO services market.2 Casey McTigue, an executive director at SRS Acquiom, an M&A services firm, put it this way: "We have seen record setting volumes for M&A." Market attention In 2019, the life sciences recruiter Pr°Clinical considered the following CROs worthy of close attention from investors and pharma alike: PPD, Medpace, PRA Health Sciences, KCR, ICON, IQVIA, PSI, Parexel.3 Of the eight, three still stand alone;the rest have merged or been acquired. Combined, their network covers 2,800 hospitals, clinics and long-term care facilities, and 200 research and pharmaceutical companies, a press release says. Since the combined R&D outlay of the top pharma houses now hovers at the $100 billion-and that majority of trials have CRO involvement-even the math challenged can appreciate the CRO industry's losses, or gains, depending on the road chosen.6 But the CRO industry has already proved its resiliency. Despite changes in market conditions between 2008 and 2019, SRS Acquiom found that of the 227 private life sciences deals in which it was the shareholder representative, 163 had earnouts, the potential dollar figure more than $37 billion.

Maximizing the Value of Remote Monitoring

The success achieved in the creation of the coronavirus vaccines, from speedy development to speedier authorization, leaves little doubt that remote monitoring has value. The trials' uniform design, standardized data language, use of central monitoring, and the heterogeneous patient population have all contributed to that survival rate. Survey respondents said COVID-19 has caused longer enrollment times (49%), amended protocols (45%), and paused protocols (41%).6 * The Oracle survey also showed that while two-thirds of respondents were using remote data collection in their trials-patient apps, ePRO and wearables-nearly half of these professionals said a primary concern with using new sources and methods of data collection was just that;shifting gears would mean adopting a new approach to manage, review, and interpret the data. * Starting last year, said Rajneesh Patil, IQVIA's vice president, Digital Strategy and Innovation, 60% to 70% of its customers looked at incorporating these standardized, transparent, remote monitoring methods into their protocol design. Agreed, said Oracle's Jim Streeter, global vice president, Life Sciences Product Strategy.

The Many Paths of Diversity in Clinical Trials

"Certain compounds affect certain populations," said Diana Foster, PhD, vice president, Strategy and Special Projects, Society for Clinical Research Sites (SCRS). A 2013 study of 167 new-molecule-based therapies showed that one in five of them acted differently in minority groups, in different races and ethnicities.4 "Diversity certainly has a higher profile now, but pharma began funding [our Diversity Site Assessment Tool project] four years ago," said Foster. COVID-19 was not the irnpetus for pharma's current focus on diversity in its trials, said Marie-Pierre Hellio Le Graverand, MD, DSc, PhD, senior vice president and Pfizer's Clinical Development & Operations, Global Product Development lead. In 1932, J.M. Adams wrote about the differences in blood pressure levels between a "group of white and [African American] workmen" in the American Journal of Medical Sciences.7 Researchers then started reporting that different types of people react differently to medical therapies.

The Future of Clinical Trial Design Looks Bright

Different stakeholders have different definitions of success, said Bill Barry, PhD, senior statistical research scientist, Rho Inc. They will all approach the trial design differently-intent to treat? Trials todsy are more tailored than necessary, said Ken Getz, MBA, founder and board chair, CISCRP and director and professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine. [...]pragmatic studies have different roadblocks. Because these trials are based on wherever the data are gathered-patient's home, doctor's office, healthcare system- the reliance on EMRs is often frustrating. In the early 2010s, the NCI and the UK's National Institute for Health Research were funding a handful of trials.5 In the UK, the first master protocol approach-using multiple treatments against one control arm-was Stampede, which started recruiting in the mid- 2000s.

The Evolution of Site Selection

Whether it was recognition, for a very long time pre-pandemic, that industry needed new ways to recruit and retain patients, or the success realized last year during the global SARS-CoV-2 vaccine trials, when pharma said we have no choice but to adopt in situ-or both reasons-the clinical trial industry is doing a 180, site-selection speaking. Syneos has the clinical trial networks;Elligo has access to Cerner and other EHR systems, said Maria Fotiu, executive vice president, decentralized solutions, Syneos Health. Healthcare, said Keith Fern, vice president, corporate development, Elligo, has become a heterogenous business. According to the Curebase website, its technology propelled the start of a COVID trial in two weeks.

The Evolution of Site Selection: New support models range from fexible software platforms, IROs, and DROs

The article reports that Curebase and Reify Health, have designed cloud-based platforms with the primary intent to speed up the site selection, patient enrollment processes, and the client desires, help with certain elements of specimen collection. Topics include business labels is in the trial-support business with its StudyTeam patient recruitment and enrollment technology platform;and Care Access decentralized research organization that brings clinical trial infrastructure to patients.