Tuesday, August 9, 2016

Where’s the Buzz in Clinical Research?

By Norman M. Goldfarb

Technology is hot. Big — or just lots of — data, visualization, the cloud, investigator site files, patient recruiting, and eConsent are prominent. Wearable technology is treading water without more professional-grade products. The challenges of prioritizing, selecting, operationalizing and integrating technology remain.

Building relationships, improving communications, growing networks, broadening product lines, and collaborating in every direction — including among competitors — are major trends, albeit far from a smooth road. Consolidation — often in unexpected ways (e.g., IMS plus Quintiles, LabCorp plus Covance, WCG Group plus CenterWatch, ICON plus PMG Research, PPD plus Synexus, and BRANY plus CITI) — continues as the ultimate expression of these trends.

Consolidation in the IRB space appears to be largely complete, with six major players, but stay tuned as the NIH requirement for single review undercuts the rationale for local review of industry-sponsored studies.

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Consolidation in the CRO space continues, but there is no shortage of companies. With the cost of capital lower than ever, expect the consolidation party to continue, provided the politicians don’t succeed in breaking the world economy. The focus of RBM has moved from “risk-based” to “remote,” with consequent cost savings but also reduced sponsor/site communications and relationships, as well as potential blind spots that require in-person monitoring. In some ways, technology is increasing communications but, in other ways, it is reducing communications.

RBM is not being adopted fast enough to counter rapidly growing demand for CRAs. As a result, years-of-service is serving as an inadequate surrogate for training and competency assessment. Personnel turnover rates are increasing across the board.

(Preferred) site networks are developing fast-startup capabilities, with pre-qualified sites, master clinical trial agreements, and pre-negotiated pricing.

Innovation, efficiency, speed and patient-centricity remain popular topics of discussion…


Author: Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information services. Contact him at 1.650.465.0119 or ngoldfarb@firstclinical.com.

First published in the Journal of Clinical Research Best Practices. © Norman M Goldfarb

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