Antiquated clinical trial industry ripe for change from innovation, experts say

By Zachary Brennan contact

- Last updated on GMT

Related tags: Contract research organization

Antiquated clinical trial industry ripe for change from innovation, experts say
Experts across the sponsor-CRO spectrum seem to agree on at least one thing: the clinical trial process is ready for a major transformation, though how quickly and what types of innovations will be adopted the fastest remains to be seen.

The theme for Thursday’s Avoca Quality Consortium in Princeton, NJ, was innovation, which both executives from sponsors and CROs said needs to be utilized to change what some are saying is an antiquated trial system.

Research from the consortium found that overall, sponsors are lagging behind CROs and other service providers in adopting innovation, particularly on the side of gauging ROI (Return on Investment).  But some think the CRO industry has a lot of work to do to ensure sponsors are using new innovations, such as risk-based monitoring, to create new efficiencies and cut costs.

Stephen Cutler, COO of Icon, said at the moment the trial industry “sits somewhere between antiquated and appalling.​” The CRO industry “needs to step up more in terms of what we offer and how we offer it …increasingly the pharma industry recognizes a level of competence that sponsors don’t have. [And] the CRO industry needs to step up and work with sponsors on the level of risk and innovation​.”

A number of experts mentioned the need for more devices to track patient data and seamlessly deliver that data to an investigative site, thereby skirting the current manual processes that dominate the industry.

Jeffrey McMullen, Vice Chairman, inVentiv Health and Chairman inVentiv Health Clinical, added that “historically patients have been secondary in terms of managing and structuring trials but accessing those patients is central to what we’re trying to do, and we need to use more effectively some of the social media approaches to reach directly to patients.”

None of us can ignore the changes taking place​,” added Pfizer’s head of clinical innovation, Craig Lipsett, noting that if Apple and Google make advances that really transform the clinical trial, CROs could see less work.

As far as CRO/sponsor relationships, a number of panelists seemed to think that for rare disease trials, particularly at Shire, sponsors are looking to use a smaller number of CRO partners and in closer relationships.

Historically, strategic relationships haven’t always succeeded because they haven’t been cared for in a way that extracts the most value​,” McMullen added.

Mitchell Katz, head of medical operations and safety at Purdue Pharma, said his company has always used an outsourcing model, but what’s important is to “leverage the relationship. That alliance is key to any trial. For us, we’ve been fortunate that as the relationships get stronger, the collaborations get better…though I would love to see more innovation come out of the CRO side…tell us what path we should be on…I still feel the mentality [from CROs asking sponsors] tell us what to do​.”

Related news

Show more

Related products

show more


Lyophilization Scale-Up and Tech Transfer

Baxter BioPharma Solutions | 12-Mar-2018 | Technical / White Paper

There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation...

Leveraging Best Practices in Primary Packaging

Leveraging Best Practices in Primary Packaging

Catalent Pharma Solutions | 05-Mar-2018 | Technical / White Paper

When planning a clinical trial, overlooking the importance of primary packaging can be a mistake. From stability concerns to labeling to patient compliance...

VDS groß

Meet the challenges of complex injectables

Vetter Pharma International GmbH | 07-Nov-2017 | Technical / White Paper

In the time it takes from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can...


Process Development for Lyophilized Products

Baxter BioPharma Solutions | 30-Oct-2017 | Application Note

Baxter approaches formulation and process development with the intention of identifying the failure points for the product. Knowing where the product fails...

Related suppliers