We strive to partner with oncology clients to serve their monitoring requirements utilizing a unique approach. We work with experienced, allied independent oncology Clinical Research Associates (CRAs) who are part of a collaborative international network, and combine our own experience in monitoring with TQM/QA business principles to optimize the complex demands of cancer studies. This leveraging of our own experience with those of the monitors creates a synergy that allows us to understand each client, their culture, protocol, primary endpoints, and both short-term and long-term goals. We then focus on the composition and ongoing management of a cohesive monitoring team with the skill sets, flexibility, and professionalism to achieve those goals. Clients have included 11 of the top 12 global Pharmaceutical companies, and multiple biologics and device clients.
Monitoring oncology clinical trials is traditionally among the most challenging and difficult roles within in a challenging field. The morbidity and mortality associated with cancer patients ensures that a high number of Serious Adverse Events (SAEs) and deaths due to Disease Progression must be monitored, traditionally necessitating an in-depth review of hospital charts, including all nursing flowsheets and medical administration records (MARs). One subject may have literally hundreds of pages of paper and/or electronic records to review, and may take all day to review eligibility criteria, medical history, concomicant medications, adverse events, and study procedures. Oncology has it's own common regimens, abbreviations, and adverse event grading criteria (NCI Common Toxicity Criteria Adverse Events, Version 4.0). A pharmacy visit and many oncology products require a particular storage, preparation, dispensing, and disposal. The evolving regulatory environment and the FDA's new Guidance on Risk Based Monitoring involves increasing Congressional oversight, and an overhaul of the Office of Human Research Protection (OHRP) is underway. Change is guaranteed - and it is coming. Most trials have discarded paper Case Report Forms (CRFs) in favor of electronic data capture systems, following the Federal mandate for 'meaningful use' of Electronic Medical Records (EMR) by the end of 2014. Initially thought to simplify and streamline clinical trials, the move to EMR is now recognized as an additional complexity for both study coordinators and monitors.
In short, an already tough job monitoring oncology trials has gotten and is getting tougher, and is evolving.
But wait - there's more:
While the pharmaceutical and biotechnology sectors have been somewhat insulated from the global recession and recovery, thousands of new job-seekers have flooded the industry seeking to become CRAs. Many come from other fields and lack medical or scientific education, training, or experience. Most that do come from within healthcare lack either oncology or monitoring experience. With the talent pool diluted, recruiters have depressed wages and employers have become more selective. but despite adding several additional layers of screening, behavioral assessments, and Skype interviews, they are hamstrung when it comes to assessing candidate skill sets. Few recruiters and Human Resource professionals possess the knowledge to adequately assess or interact with the talent. Buzzwords and extensive experience questionnaires become screening tools, and savvy candidates have learned to play along and polish their interview skills to get the job. Monitoring oncology is such a tough field, it may not become apparent until an audit, often months or even years later, whether a CRA has done an effective job.
By contrast, if you are an experienced monitor, you can pick up almost immediately whether or not someone knows what they are talking about and whether or not it's based on practical experience, how thorough they are, and whether or not they monitor to client expectations and Standard Operating Procedures (SOPs), or are doing their own thing. It's easy if you know the right questions to ask, but you have to have been an oncology monitor for several years to assess it properly - which very few people in this role have done. Turnover remains high, and companies now are generally satisfied if an oncology monitor stays on for a year, and thrilled if they are actually on board for an entire study. In practice, that usually doesn't happen, because it's all based on a business model that, frankly advertises the monitors qualifications during the bid and approval or hire process, then relegates them to warm bodies producing long, unnecessarily bureaucratic reports that contain very little useful information but serve as a deliverable to justify what the sponsor is paying for. These reports are wasteful and of minimal use to FDA auditors, who rarely consider them in an audit, realizing they have been sanitized of all but the required elements during the review process prior to submission to client companies.
So CRAs, particularly contract CRAs, move on, for a variety of reasons; it's part of the business model employed by the CROs that they are expendable once they have passed the break-even point of approximately a year. Deficiencies are covered up or easily explained away. Sponsor companies wont' hear from these monitors, lest they not be paid. There is constant turnover in our industry, not only the monitors and coordinators, but also project management at the CRO and sponsor companies. The process begins anew with each change, and recruiters and CRO's are able to cast themselves in the role of a 'White Knight' - coming to the rescue in situations that by are larege, they themselves helped to create in the first place by paying low, and providing little or no practical training or oversight, few reasons to stay on, and several to leave after the hire when the scope of the task gets its final reveal. The truth in the industry we all learn in our first monitoring job is that the more chaos, delays, poor communication and management on our end, the more profits for the companies we work for as well as ourselves, and increased cycle times and reduced profits for the sponsor companies we work for, but alas rarely directly communicate with - because it's designed that way. There is an inherent conflict of interest in business as usual between the executive branch that negotiates a monitoring contract and the clinical arm charged to implement it. The system is designed to get your business initially with a low bid and then make up for with change orders later for 'unforseen' costs that we all know are necessary and should have been part of the initial proposal.
That's simply wrong, it's unethical, and it's going to change. It's not a question of how but when. When sponsor companies have unfettered access and communication with the monitors who represent them to the sites and can tell them more about their study in 5 minutes than the typical hour an half weekly CRO call, light bulbs will go off. The CRO's aren't needed; the FDA's new Risk-Based approach practically has this as it's underpinnings. Rather than do the exhaustive monitoring we now do for each patient, do what every other scientific discipline does with valid, tested through statistics and practical experience - random sample for cause monitoring - and other than that, critical fields and primary endpoints only. That's such a hard concept for most CRAs, CRO's and even sponsor companies to get their heads around most simply refuse to adopt this approach outright, insisting that the only way to be 'protected' is to monitor everything - just in case - because your reputation is on the line. Right - it's a direct economic threat to an established way of doing business that is now up to 13.6 BILLION dollars as of 2012 - they aren't going to change overnight that easily.
At Oncology Monitors we don't have to change. We are not warm bodies, we are the best at what we do, and we will share our expertise with you to actually reduce your cycle times and get your drug approved faster, or decide it's not worth pursuing earlier. We have no conflicts of interest, because our business and monitoring executives are one and the same - we all monitor - with senior staff devoted exclusively to Quality Assurance (QA) to ensure that everyone is on the same page, and that you are getting what you pay for. That's not the same as a for cause audit of a monitor or a confidential annual evaluation most companies promise but fail to deliver and not share with you. All your QA auditor will ever see is a CRA's training file - reduced to scores from literally hundreds of electronic quizzes in a database - none directly related to oncology knowledge, by the way, and in as much as they relate to your trial, a few require actually reading the protocol, but that is rare. Attend a Site Initiation Visit with us and see what we can do. Better yet, attend an interim monitoring visit and see what 90% of this is about - the man behind the curtain sponsors are traditionally told not to pay attention to, just like in the Wizard of Oz - but it's where the rubber meets the road and you see what kind of quality you can get in 2 days to check off 80 to 100 boxes on a trip report, meet with the PI, conduct a pharmacy visit, monitor the regulatory binder, and meet with the study coordinator and go over queries.
Don't worry - there is a better way - and by coming to this page, you've found it, whether you be a prospective client or CRA. We do things differently. We know our core competencies and have no ambition to expand beyond them. We know our niche and will not deviate from what we do best. We'll leave changing the world to itself, but we're doing our part in our corner of it to lead the way and show how oncology monitoring should be done.
