Survey: Could We Do Better with Site Initiation/Startup?

Inefficient site initiation/startup affects trial launch and impedes enrolling participants. A recent publication by KMR Group revealed that clinical trial cycle times are getting longer however; one of the areas with the greatest opportunity to reduce the trial cycle time is in site initiation/startup.

Few specific metrics for site startup activities exist, other than generalizations, about where the time and resources are being wasted in this process. Subjective data merely states that it takes too long, or requires too many people, or no one knows if a site will ever be opened, nor the criteria for dropping a non responsive site.

The goal of this anonymous survey from PatientQuest is to request your best quantitative estimates as to the time or manpower it now requires to get one or all your sites opened.

Survey results will be published in peer reviewed articles, Lunch ‘n Learn webinars and industry conference presentations.

Take Survey

Coordinator Debarment a Wake-Up Call for Clinical Trial Sites, Sponsors

Bev. H. Lorell, MD, King & Spaulding

Earlier this month, the U.S. Food and Drug Administration (FDA) debarred a study coordinator for a drug clinical trial at an institution in the agency’s Northern District of Illinois, alleging the use of fictional patients and skewed reports, among other serious charges. While it represents an “extreme and rare example,” the FDA’s action should serve as a reminder and wake-up call for sites and other personnel, says Bev H. Lorell, MD, a consultant with law firm King & Spaulding.

Sponsors need to spend enough time on due diligence to ensure that a principal investigator (PI) has the time and resources to work closely and in an ongoing basis with study coordinators, Lorell says. Sponsors should also make it clear that they intend to follow through with PIs, and will expect them to remain personally involved in the trial from start to finish, she adds.

Sponsors must actively engage their senior leadership to work with PIs and discuss expectations in terms of patient engagement and other hands-on aspects of the trial, Lorell says. Sponsors need to have a system in place where they can spot red flag outliers early—such as trial enrollment occurring much more quickly than expected, or a lack of reported adverse events in a high-risk situation—and swoop in to make sure the trial is following protocol. Risk-based monitoring (RBM), executed properly, can help sponsors and PIs recognize and address potential trouble areas early in the cycle, Lorell says.

“Too often these sponsor interactions occur only with the study coordinator, when it is the PI who has the ultimate oversight,” Lorell says. The FDA knows PIs are overextending themselves, she adds, noting that, “It recognizes that [overextension] is a problem, and that’s why one of its major initiatives” is to promote increased use of RBM. Time and money costs can be significant when setting up an RBM system, she acknowledged, but the long-term benefits make it well worth the effort.

Related Resources:

• GCP for the Experienced CRC: Partnering with Your Investigator to Reduce Risk and Avoid Common Inspection Findings
• Ethics and Human Subject Protection

Tight Trial Market Demands Clinical Trial Sites Employ New Business Tactics

Christian Burns, ClinEdge

With a tightening clinical trial marketplace and an increasingly stagnant per-patient value, study sites are under ever-greater pressure to find new ways to reach new subjects and satisfy some wary sponsors, says Christian Burns, a specialist in clinical site business development and patient recruitment with ClinEdge. The key is flexibility and recognizing new market segments.

For example, psychiatric trials have been booming for the last several years, but have begun to slow down. Flummoxed, leaders at sites with a heavy concentration on such trials find their specialized staff grappling with ways to adapt. Burns advocates finding areas of overlap, such as narcotic pain medicine trials. “In many cases, there is a component of pain” when working with trial patients suffering from depression or bipolar disorder. Sites can shift their strategy to include some of those patients without needing additional physicians because of that untapped overlap. It is more a case of finding new ways to leverage existing assets.

However, there are some instances where moving into a new market segment necessitates the hiring of a new principal investigator (PI), Burns notes. In those cases, it is critical to know how to identify and recruit the right kind of professional. Burns advocates several tools, including a “lunch and learn” presentation to be delivered to top candidates. A strong presentation should include:

• An overview of the site’s experience and reputation
• Highlights from innovative clinical treatments the site has had experience with and that would appeal to the prospective hire
• A clear discussion of what a site expects from a PI — “Most PIs don’t understand their role,” Burns says.
• Transparent discussion about study budgets — “Transparency is huge,” he stresses.

Sites must also confront the reality that, in many cases, their relationship with sponsors is frayed. Roche, Pfizer, and others have expressed frustration with sites that promise 50 test subjects and ultimately produce only 10, Burns says. To be fair to sites, he adds, sponsors more and more demand subjects applicable not just to a single condition (e.g., diabetes). Instead, they want a subject relevant to diabetes, severe heart disease, and hypertension.

Again, flexibility is key, Burns stresses, saying, “It’s about building a multispecialty site with more flexibility to adapt to change.”

Burns will lead a webinar, Breaking into New Therapeutic Areas, April 27 at 12:00pm EST. Click Here to sign up.

New Report Shows Clinical Trial Sites Value Communication, Protocols, Monitors as Most Critical to Relationships with CRO, Sponsor Partners

Clinical research site staff report communication, protocols, and monitors as the three most critical aspects of successful relationships with their CRO and sponsor research partners, according to new data from a collaborative research study by ACRP and CRO Analytics.

In a survey of nearly 300 clinical research sites, the majority of respondents listed these three aspects of clinical trials as most critical to fostering positive relationships between sites, sponsors, and CROs.

Using a predictive modeling methodology, CRO Analytics found that communication is viewed by sites as the single most important factor in clinical trial quality.

Anthony (Tony) Busa, President and CEO of Meridian Research Inc.

“Frequent and open communication between sites, sponsors, and CROs is critical to the success of a clinical trial,” says Anthony (Tony) Busa, President and CEO of Meridian Research Inc., a Florida-based site network with five privately owned research facilities. “When there is good bi-directional communication, sponsors and CROs can learn about potentially troubling issues with a study in time to address them. From a site’s perspective, if a sponsor is engaged we feel their concern for the study and we also tend to pay more attention to a study if we know the sponsor is actively involved.”

Communication builds relationships, and Busa notes that he’s seen a direct correlation between successful studies and strong relationships between sponsors, CROs, and sites.

“Good ongoing communication will also yield good long-term relationships, which can ultimately benefit a drug’s overall development program,” Busa says. “Sites want to perform well on each and every study, and the stronger the relationship between the sponsor, CRO, and site the greater the potential for a successful study program.”

This new research for the first time confirms those aspects of clinical trials that sites believe are most critical to successful site relationships and how their CRO and sponsor research partners are performing on those items.

Complete study results, including how sites compare the performance of sponsors and CROs, will be presented April 16 at the ACRP Executive Summit on Site Strategies during the ACRP 2016 Meeting & Expo.

Learn More

For more information about the ACRP 2016 Meeting & Expo, please visit www.acrp2016.org. For more information about the ACRP Executive Summit on Site Strategies, please contact Arminda Valles-Hall at avalles-hall@acrpnet.org.

To learn more about Site Voice, please visit www.croanalytics.com, or see the ACRP, CRO Analytics March 21 joint press release.

ACRP Calls for Focus on Competence as Solution to Shortage of Monitors in Clinical Research Workforce

New CWWeekly Article Calls Industry-Wide Practice of Requiring Two Years’ Experience Before Assigning Monitors to Clinical Trials “Major Issue” Contributing to Shortage

The Association of Clinical Research Professionals (ACRP) continues calling for a groundbreaking shift in the clinical research industry: elimination of the commonly accepted and practiced two-year experience requirement for entry-level Monitors/Clinical Research Associates (CRAs) in favor of competence-based employment practices.

An article in today’s CWWeekly (“The ongoing CRA shortage: Competency versus experience”) notes that “at least 10,000 open CRA positions” exist in the United States alone and that “ongoing concerns about a global shortage” were rekindled last week at the Clinical Trial Collaborations conference in Boston, Massachusetts.

“There has been an exponential demand and growth in the clinical studies space in the past five or 10 years,” ACRP Executive Director Jim Kremidas is quoted in the article. “We have a shortage not only of CRAs, but of Investigators, clinical coordinators and more. The entire industry is under stress with the amount of research that’s being conducted and the resources available.”

While the CWWeekly article notes there is “some dissent over various reasons for the shortage, most agree that a major issue is the industry-wide practice that requires CRAs to have a minimum of two years of experience before being assigned to a trial.”

“ACRP, among others, is working to change that mindset, while still ensuring quality in the profession,” the article continues.

“The most important factor is the requirement of two years of experience before being considered a qualified CRA,” Kremidas is quoted as saying. “It’s a random marker. Time in a job is not necessarily indicative of whether somebody does it well or not.

“We suggest throwing the two year arbitrary experience requirement out the window and focus on the competencies required for the job,” Kremidas continues. “We’d like to define an industry standard that everyone agrees upon, one that says if a person has this type of education, training and experiences, they are qualified to be a good CRA.”

ACRP initiated calls for changes in CRA hiring practices in a September 2015 Position Paper, A New Approach to Developing the CRA Workforce.

ACRP’s CRA Workforce Task Force, announced late last year, will convene in April at the ACRP 2016 Meeting & Expo in Atlanta, Georgia, to define the core competencies required of entry-level CRAs. The task force further charged with developing measures of competence and advocating for standardization of identified competencies across the clinical research enterprise.

Click Here to learn more about a Harmonized Core Competency Framework for the Clinical Research Profession.

Onboarding Done Right Cuts Turnover by Half, Boosts Productivity

Liz Wool, RN, BSN, CMT, CCRA, Global Head of Training, Barnett International

More than one-third of employees make their decision to stay or go within the first month of employment, studies show. Given today’s scramble for talent, now is the time to leverage any tool that can help retain top performers, says Liz Wool, RN, BSN, CMT, CCRA, Global Head of Training, Barnett International.

Studies have also shown that a strong onboarding template, tailored to an individual employee, can cut retention by half and more than double that new employee’s productivity almost from day one, she adds.

“The first day on the job is the most critical day in terms of the employee’s lasting impression of his or her new employer,” Wool notes. Managers should show enthusiasm for their new employee with an air of excitement (“I’m so glad I was able to get your talents for our organization”) to an onboarding process that demonstrates the manager took the time to do it right. There’s nothing worse than appearing disorganized and making the new hire feel as though the manager threw something together haphazardly, Wool says.

Wool, who was trained as a nurse, draws on that experience when she helps develop onboarding programs. She suggests spending two to four hours before the employee’s first day to tailor a program, then devoting a few hours each week to checking in with the new hire. Wool advocates creating an onboarding program based on addressing the “four Cs”:

1. Compliance: Foster the employee’s understanding of the regulatory requirements of the position.
2. Clarification: Make certain, via job description and other tools, that the new hire has a clear sense of his or her specific responsibilities.
3. Culture: Help them understand the real day-to-day way to get things done.
4. Connections: Help them better understand and leverage the culture by working to connect them with established employees in similar and complementary roles. This helps everyone get “the big picture,” Wool says.

Wool, a top-rated speaker, will lead a session, Create an Onboarding Curriculum that Fits Your Budget, during the ACRP 2016 Meeting & Expo in Atlanta, Ga., April 16-19.

Need Onboarding Support?

Get your new CRCs and CRAs to hit the ground running with an ACRP Onboarding Program. Our intensive in-person onboarding programs for CRCs and CRAs can be customized to meet your unique needs, lasting up to 8 weeks. Your new hires will be positioned to make an immediate impact, saving your organization time and money.

Contact Jenna Rouse, ACRP Director of Business Development, at jrouse@acrpnet.org or call +1.703.254.8109 for more information.

Q&A: Key Elements, Strategies for Increasing GCP Training Efficiency

A new paper published by Clinical Trials Transformation Initiative (CTTI) in the DIA Therapeutic Innovation & Regulatory Science journal identifies key elements and strategies for increasing Good Clinical Practice (GCP) training efficiency (see Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency).

Dr. Jonathan Seltzer, MD, MBA, President, ACI Clinical

We spoke to one of the paper’s authors, Dr. Jonathan Seltzer, MD, MBA, President, ACI Clinical, about CTTI’s recommendations.

Q: CTTI’s recommendations state that advanced and role-based GCP training should be considered for those who have already completed initial GCP training. What value do you see in providing advanced-level GCP training, rather than repeat initial GCP training, to investigators and the clinical research industry at large?

Dr. Seltzer: Advanced or real-world training that integrates adult learning methods, such as interactive feedback, case studies, and group exercises, may provide a higher degree of knowledge retention. However, this format may be challenging to administer to large, diverse audience, since many of these trainings may require in-person training.

Also, consideration should be given to whether training by active involvement or serving as a Principal Investigator (PI) in new studies could be an indicator of GCP competence, and thus should qualify as acceptable training. Another approach is to foster mentoring programs where new investigators are paired with more experienced mentors who provide guidance on interpreting and building upon the fundamentals of GCP.

Q: Same question for investigator-specific training?

Dr. Seltzer: Some of the 13 key elements of GCP training may require deeper focus depending on the individual’s role. For example, the element “Investigator’s Qualifications and Agreements” specifies that the investigator should be able to identify what it means to be a qualified investigator with a qualified team, know how to supervise and delegate tasks, and know what is required in Form FDA 1572 (“Statement of the Investigator”). However, a GCP course for a study coordinator at a site may focus on other elements related to site support duties such as data management and trial records.

Q: While not making a specific recommendation in support of online GCP training, CTTI does state that an online format “may be the most practical to impart GCP training.” What challenges do investigators face that would make online GCP training a more practical option?

Dr. Seltzer: Time and resource constraints are challenging within all professions, and clinical research is certainly no different. Since clinical trial participant visits often occur during workday hours, and online learning can essentially occur at any hour of any day, the flexibility provided by online learning could be more practical than other options. However, while online training is attractive because of flexibility of access, CTTI heard concerns from some individuals that online learning may not be retained as well as in-person approaches. CTTI prefers to allow flexibility to the administering institutions to fulfill their specific needs.

NIH Office of Science Policy Unveils New Resources

The National Institutes of Health’s (NIH’s) Office of Science Policy (OSP) just launched a listserv designed to speed dissemination of updates on policy areas including biosafety, biosecurity, and clinical research. The move is part of a broader “organization restructuring” says Ryan Bayha, director of strategic engagement. Details on those changes are expected in the next few months, he said.

In addition, OSP is promoting a blog written by Dr. Carrie Wolinetz, NIH’s associate director for science policy. It’s all part of an enhanced stakeholder outreach campaign, according to Bayha.

To subscribe to the listserv, click here and then choose the “subscribe” option. You may also subscribe by sending an e-mail to listserv@list.nih.gov with the message: Subscribe OSP_News.

To subscribe to the blog, go to: http://osp.od.nih.gov/under-the-poliscope.

For more information about OSP, please visit its website at: http://osp.od.nih.gov/. Questions may also be sent to SciencePolicy@od.nih.gov.

Remote Monitoring Threatens to Increase Site Challenges

Sandra SAM Sather, MS, BSN, CCRC, CCRA, vice president at Clinical Pathways, LLC

Remote monitoring is here to stay, says Sandra SAM Sather, MS, BSN, CCRC, CCRA, vice president at Clinical Pathways, LLC. That said, she wonders if it increases the burden on research sites to de-identify subjects’ medical records.

She notes that, in many cases today, it does increase that burden and often blocks access remotely to subjects’ records. That’s the bad news. The good news? According to Sather, it doesn’t have to be that way. The key is to have the right agreements and processes in place.

“We can address the barriers and burden for clinical research associates and research sites to support monitors’ access to subjects’ source documents without de-identification before the review,” Sather says. “Many think the Health Insurance Portability and Accountability Act restricts research sites from disclosing patient records for monitoring review (even remotely), but that’s a myth.” De-identification can also waste a lot of time and resources, she adds.

Sather and colleagues Kelly Cairns, MA, BASc, APMR, CCRA, leader for clinical trial operations with Boehringer Ingelheim (Canada), and Dr. Gil Price, CEO and owner of MaGil IRB & Drug Safety Solution, will present Remote Monitoring and Access to Electronic Medical Records at the ACRP 2016 Meeting & Expo, April 16-19, in Atlanta, Ga.

Getz: Exciting, Transformational Time to Be a Clinical Researcher

Ken Getz, director of sponsored reasearch and associate professor at the Tufts Center for Study of Drug Development and founder of CenterWatch

Powerful forces of change are transforming the clinical trials landscape—and that’s a good thing, says Ken Getz, director of sponsored research and associate professor at the Tufts Center for the Study of Drug Development and founder of CenterWatch.

“It’s exciting but also daunting, because it forces us to confront and consider” structural and operating changes that will impact the industry for generations to come, including the latest wave of consolidation driven by contract research organizations, institutional review boards, and investigative sites, he notes.

Getz lauds this “paradigm shift” in part because it will advance the use of e-data, remote and risk-based monitoring, and other analytical tools.

Clinical research associates (CRAs) must be prepared to meet new performance expectations, Getz says. In addition to embracing new technologies and new ways to collect clinical trial data, CRAs will need to learn how to function effectively in larger site networks and health systems, where more physicians and data are drawn from satellite offices and remote locations.

“Trends and changes are unfolding that will profoundly impact how our enterprise manages its innovations and how it will operate and perform,” he says.

Getz will discuss these major changes in April at the ACRP 2016 Meeting & Expo in Atlanta, Ga., including:

• growth of precision medicine;
• the consolidation of research sponsors and service providers;
• the convergence of clinical research and clinical practice;
• the use of wearable and mobile devices and new technology solutions; and
• more sophisticated uses of large and growing structured and unstructured data and information for scientific and management purposes.

The overarching consolidation could improve operating performance through efficiencies of scale; broader adoption; and more systematic and consistent execution. “As sectors across the drug development landscape achieve new levels of operating scale, the breadth and depth of healthcare and clinical data and powerful analytical tools will drive major improvements in detecting safety and efficacy signals, risk-based management approaches, and predictive recruitment and retention,” Getz says.

Learn more about Getz’s presentation, An Aerial View of Forces Reshaping the Global Clinical Research Enterprise.