29
Jan

Millennials in Research: New Ideas to Think, and Run Your Studies

Guest blog from prcclinical.com

T.-Taricco - PRC - ClinovoTony Taricco co-founded PRC Clinical in 2003. As the President and board member, he is responsible for the general business operations and finance activities, as well as human resources, and clinical payment services.Tony spent 20 years in Workers Compensation Insurance, starting as a Claims Adjustor for a small company of 25 employees and growing with that company to the position of Vice President and a staff of nearly 300. Tony’s business degree and extensive practical experience in business growth brings together the unique perspective of understanding the values and challenges of a small business and molding those into a strong foundation for long term expansion.

Recruiting for clinical trials is notoriously difficult and social media sites like Facebook and Twitter are being used to even out the odds. But it took a 21-year-old worker to come up with the idea of pitching a trial on Snapchat. The clinic signed up a participant the same day. “That was an eye-opener for me,” said Dan Sfera, a consultant to research clinics. He wouldn’t have thought of Snapchat, an app favored by teens and 20-somethings. Sfera is only 34.

FUTURE LEADERS

The story is just one example of how millennials, the generation born roughly between 1980 and 2001, are making their mark on clinical trials. As digital natives at ease with social media, they are helping companies find faster, less expensive and better ways of operating.

Already the majority of the staff coordinating and handling day-to-day tasks involved in clinical trials are millennials,according to James Denmark, founder and CEO of myClin Clinical Research.[1] They might be handling operations entirely at some small sites.

“If you fast-forward about five years, you’re going to find that almost all of the field research is being performed by the millennials,” Denmark said during a video conference to discuss the report, “I’m the Millennial That Is Running Your Clinical Trial.”[2]

Another 10 years and they will dominate the entire ecosystem, Denmark said,[3] estimating that millennials already represent 73 percent of the clinical trial-related workforce.

The percentage may not be surprising given that more than one-in-three U.S. workers today is a millennial. But it may be more surprising that this year millennials surpassed Generation X (the age group that most of upper management in the clinical trial industry fit into) to become the largest share of the country’s workforce, according toPew Research Center analysis of U.S. Census Bureau data.[4]

DIGITAL NOMADS

Predictions are always tricky but ignoring them risks eliminating a major pool of employees and tomorrow’s VPs. Millennials — those running clinical trials as well as those participating in them — are having an effect on the industry that reaches into their structure. Clinical trials are marked by a series of complex, rigidly defined steps and regulations. In contrast, the millennial generation has been raised on the legends of tech startup founders who became billionaires largely on their own terms. The result is a generation with a low tolerance for unfriendly processes and systems.

They believe clinical trials should be centered around what matters to patients rather than solely what is of interest to the people behind the studies. They also tend to be uncomfortable with rigid corporate structures and reject information silos. And they have a reputation for being self-starters. But they expect constant feedback as they try to advance quickly up the corporate ladder during a varied and interesting career at multiple companies.

Technology is helping to drive these expectations. Millennials are the country’s first “digital natives.”[5] In other words, they are the only generation so far which has not had to adapt to new technologies. Being digital natives means millennials are used to getting the information they want when they want it and from a multitude of sources such as social networks, rating websites and word of mouth referrals, according to MD Connect, a digital medical marketing agency. “The first thing a millennial does is Google something,” Jonathan Catley, MD Connect’s sales and marketing director, said.

They have grown up with broadband, smartphones, laptops and social media being the norm and expect instant access to information, according to an online survey of 4,364 new college graduates by PricewaterhouseCoopers.[6]“The millennial generation’s world is digital and this has an inevitable effect on the way they communicate,” according to the report, “Millennials at work: Reshaping the Workplace.”[7]

That means communicating online or video conferencing rather than face-to-face or over the telephone. Email still has a place but “absolutely forget about faxes,” Denmark said. Instead, millennials expect[8] to be mobile, working with their smartphone from home, the office or cafes.

Millennials say[9] they routinely make use of apps running on their own smartphones, tablets and laptops while they are on the job. They often work outside of normal business hours, with about a fifth of them identifying as “night owls.” In other words, as the PricewaterhouseCoopers report put it, “millennials want a management style and corporate culture that is markedly different from anything that has gone before – one that meets their needs.”

Being a wired nomad may not as feasible for clinical trial workers as their peers in other industries because of concerns about compromising patient privacy by using insecure mobile technology. Indeed, encryption will be an issue that companies have to tackle as employees regardless of age and industry increasingly use their own devices filled by an array of apps.

TAMING THE PAPER STORM

Of course, changes are not easy, but John Silowsky, the clinical operations chief Bay Area-based Nektar Therapeutics, said the effort paid off when the company launched a Phase III program of a compound designed to treat chronic pain.

He knew he had a young staff that wouldn’t put up with the slow, top-down approach of most trials. So he decided the company was going to go in a new direction by “tearing down the walls” between Nektar and the vendors and sites involved in the program.  Silowsky brought in research sites and investigators early on, even before the protocol was developed “to make this journey” as a team.

“We were going rough and raw and putting out our work out there in the public space and making it available for review and comment,” he said. “It was scary.” But they tamed the paper storm and made the process more efficient and concise. It “took us to another level of collaboration,” Silowsky said. “We’re only a click away from our investigators our site staff and more importantly from our patients”.

By Tony Taricco, Co-Founder and COO at PRC Clinical

[1] http://xtalks.com/downloads/15q058.pdf

[2] http://xtalks.com/thankyou-15q058myclin.ashx

[3] http://xtalks.com/thankyou-15q058myclin.ashx

[4] http://www.pewresearch.org/fact-tank/2015/05/11/millennials-surpass-gen-xers-as-the-largest-generation-in-u-s-labor-force/

[5] http://www.mdconnectinc.com/about-md-connect/medical-marketing-insights/bid/77788/healthcare-marketing-and-the-millennials

[6] https://www.pwc.com/m1/en/services/consulting/documents/millennials-at-work.pdf

[7] https://www.pwc.com/m1/en/services/consulting/documents/millennials-at-work.pdf

[8] http://www.halogensoftware.com/blog/generation-y-understanding-the-work-habits-of-millennials

[9] https://www.pwc.com/m1/en/services/consulting/documents/millennials-at-work.pdf

27
Aug

Make the Switch to Electronic Data Capture (1/2)

Electronic Data Capture (EDC) collects clinical trial data electronically rather than on paper. It is becoming an increasingly popular solution for streamlining clinical data processing. Studies suggest that using EDC systems drastically reduces data errors and speeds up the overall trial process, therefore reducing clinical research costs by up to 20%. Clinical data quality is also dramatically improved when relying on EDC: According to the Regional Operations Manager at Eli Lilly in Canada, implementing an EDC system resulted in a 70 to 80% reduction in queries.

edc-adoption

 

However, the adoption of EDC (Electronic Data Capture) systems has remained slow in some segments of clinical research. According to Datamonitor, the market intelligence and data analysis firm, only 40% of Phase I clinical trials had adopted EDC by the end of 2011. 60% of Phase 2 clinical trials, 80% of Phase 3, 70% of Phase 4, and 5% of “Others” (non-FDA regulated studies) are utilizing EDC systems.

A potential steep learning curve for clinical research teams, structural changes in organizations, and perceived high cost of EDC implementation are some of the legitimate reasons to hesitate before adopting EDC. However, considerable time- and cost-savings, along with drastic data quality improvements outweigh these difficulties. This paper aims at clarifying and facilitating the process of switching to Electronic Data Capture (EDC). We have listed below some of the essential points to consider before selecting and implementing an EDC system.

 1. Track Record

 The first thing to consider is the track record of the eClinical system vendor: How long have the vendor and its EDC system been on the market? On how many studies has the system been implemented? Can the vendor produce testimonials and case studies from past customers to substantiate its marketing claims? Was the system utilized for any FDA submissions?

2. Regulatory Compliance

Make sure the EDC system you’re evaluating is 21 CFR Part 11 Compliant. Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) is the United States Federal Regulation which applies to electronic records and electronic signatures in clinical systems. Also take EU regulations into consideration if you’re planning on running clinical trials in Europe.

  1. EDC systems must track all data changes in audit trails in order to be 21 CFR Part 11 compliant. Any change to any record is captured in the audit trail and these entries are time stamped with additional information including operator name and why the record was changed.
  2. The EDC system provides adequate security to prevent unauthorized modification by ensuring role-based access and preventing users from directly updating the database.
  3. The software employs electronic signatures for any transaction into the system.
  4. Vendors must also plan for disaster recovery and analyze and remedy potential risks.

We have found that some popular cost-efficient Electronic Data Capture (EDC) systems on the market are not 21 CFR Part 11 compliant, such as REDCap. These systems cannot be used for FDA-regulated clinical studies, but only for research and investigational purposes.

3. Data Security

Most EDC vendors offer a “secure hosting”, but we recommend to take a close look at where and how clinical data is being stored. Does the vendor provide disaster recovery? Is the data center SSAE-16 compliant? SSAE-16 (Statement on Standards for Attestation Engagements (SSAE) No. 16) defines the standards an auditor must employ in order to assess the contracted internal controls of a service organization, such as co-location service providers, including network and system management SOPs, security and business continuity.

4. Pricing model

The cost of implementing an EDC system can dramatically vary from a few thousand dollars to half a million dollars. Most EDC systems vendors charge customers a high upfront cost to cover heavy development and customization costs. The pricing model of most EDC systems is thus not transparent and varies depending on the project. Some systems will charge you depending on the number of users, which is well adapted to small clinical trials, but reportedly not scalable for longer and larger clinical trials.

Sophie McCallum

Director of Operations at Clinovo

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Make the Switch to EDC

Extract of Clinovo’s White Paper “Make the Switch to Electronic Data Capture”

Read the full White Paper on clinovo.com/papers

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