The Triumph Fund believes that, if it seeks donations to support a cause, it’s donors are entitled to know how the donated funds are used. The Triumph Fund has previously posted on this blog the extremely limited use of funds for administrative purposes. This post now delves into the manner in which the Clinical Trials Office of the Medical College of Wisconsin has made use of the funds donated to it by The Triumph Fund – donations allowed due to the selfless individuals who themselves have donated to The Triumph Fund.
As one sees in reading this post, the CTO has made a productive use of these funds by: i) building a much needed and technologically advanced education center in which, among other things, CTO staff meets with representatives of the National Cancer Institute, pharmaceutical companies, biotechnology companies, and scientists to implement and discuss clinical trials and then trains its staff to carry out he trial; and ii) advancing the national certification and professional education of its staff, much of which is undertaken in that education center.
The Clinical Trials Office of the Medical College of Wisconsin Cancer Center (CTO) has been extraordinarily grateful to The Triumph Fund for its generosity. That gratefulness was evident this past February when John and Janis Hovel, two of the founding members of The Triumph Fund, visited the CTO’s offices and visited with its leadership, including Dr. James P. Thomas, the Medical Director of the CTO, and Betty Oleson, its Administrative Director. We also met and had the chance to visit with many of the talented professionals on the CTO’s staff.
That visit verified for The Triumph Fund the wisdom of promoting clinical trials – that is, the visit confirmed the fund’s decision to raise money to assist the CTO in moving new and innovative cancer treatments from the laboratory to the patient. That visit also revealed the deep appreciation that the CTO has for The Triumph Fund and its many donors. In fact, it is hard for The Triumph Fund to put into words the depth of the gratitude shown by the CTO, as illustrated by the kind words spoken.
As of the end of 2013, after less than one year in existence, The Triumph Fund had donated almost $30,000 to the CTO. As of the end of April 2014, in significant part due to donations made to the insoluble memory of Mark Vetter, a friend of The Triumph Fund who passed from this earth in January after a valiant fight against cancer, that number had climbed to in excess of $45,000.
II. Helpful Definitions:
First, a review of a couple terms that are used in this post and that this blog has used often:
Clinical trials are a form of clinical research that involves patients, many of whom have few if any other established treatment options remaining. The National Cancer Institute explains that “they are the final step in a long process that begins with research in a lab. Most treatments . . . use[d] today are the results of past clinical trials.” In a cancer setting, most clinical trials are designed to find new ways to treat the disease, manage its often painful and life-disruptive symptoms, or diagnose the disease.
Translational research is closely aligned with clinical trials. It takes scientific discoveries and puts them into practical applications beneficial to cancer patients. One Nobel prize winner has described the term as follows: “Translational research can be pictured in the following way . . . I have a scientific insight. I develop a drug for that scientific insight, or a new therapeutic approach . . . You have to find the cancer patient who would respond to this drug, and you have to deliver it to that cancer patient in a compassionate and reasonable way to see if you can get maximal response.”
III. The Nicholas Family Foundation Translational Research Unit:
In October 2014, the CTO showed its commitment to clinical trials when it opened the Nicholas Family Foundation Translational Research Unit (TRU) at the MCW/Froedtert Hospital Clinical Cancer Center, which houses the CTO. Built with funds selflessly donated by the Ab Nicholas Family Foundation, this beautiful unit is the location in which cancer clinical trials at MCW are actually carried out. The TRU is located adjacent to the “Day Hospital,” where established chemotherapy and other services are delivered to patients
As the MCW website states, “[t]he TRU space is devoted to early-phase investigator-initiated cancer research trials, one of only a few in the nation with the capability to conduct early-phase cancer clinical trials in dedicated space with experienced research staff.” The website explains that the TRU: i) was designed to “accommodate novel ‘first in man’ cancer treatments” and ii) that for researchers and clinicians at MCW it “is a powerful tool in translating laboratory research into patient care.
Immediately below are photographs of the TRU taken shortly before its October 2014 opening:
IV. The Legacy of the Donated Funds:
During this February 2014 visit to the CTO’s offices, we discussed the use that the CTO has made and is thinking of making of the funds we have donated. That discussion took place in “The Lorax Classroom” which, as is explained below, is a combination classroom and conference room created solely with those funds. Betty Oleson, the Administrative Director of the CTO, then followed up that discussion with a report on the use of the donated funds.
The CTO has been happy to provide that information to The Triumph Fund. In turn, The Triumph Fund is delighted to share with you, our donors and supporters, the uses to which the CTO has put and is putting the donated funds. One can readily see that the donated funds are furthering the CTO’s goals of increasing the number of early phase clinical trials available in Wisconsin and maintaining a talented and highly trained staff. As you will see, The Triumph Fund is helping make a tangible difference.
Below is a summary of the ways to which the CTO has put and is putting the money donated by The Triumph Fund’s many generous donors.
1) Education and Training in “The Lorax Classroom.” Using only funds donated by The Triumph Fund, the CTO has converted a copy room in it’s offices in the MCW/Froedtert Hospital Clinical Cancer Center to an education center – a combination classroom and conference room. Proudly showing appreciation for the funds our generous donors have contributed, the CTO has named this education center “The Lorax Classroom” and has decorated it in theme – with a picture of The Lorax himself staring at the proceedings, surrounded by a forest of truffula trees. To complete the theme, there on the wall are the inspiring words of The Lorax, as penned by Dr. Seuss, on which The Triumph Fund has fund inspiration: “Unless someone like you cares a whole awful lot, nothing is going to get bettter. It’s not.”
Below are photographs of The Lorax Classroom:
The Lorax Classroom can comfortably accommodate 10 to 12 individuals and, as the above photograph show, is equipped with a large wall monitor, state-of-the-art audio-visual capabilities, a conference phone, and a conference table. To the envy of many other specialized offices at MCW and Froedtert Hospital, The Lorax Classroom is used solely by the CTO and is designed to carry-out many of the behind-the-scenes functions of the CTO. Its primary purpose is to provide a technologically advanced space with which to educate and train CTO staff and to meet with third-parties who design, coordinate, and evaluate the results of clinical trials.
The following are just two examples of the use the CTO makes of The Lorax Classroom:
a) Protocol Training for Clinical Trials. The Lorax Classroom is a location for meetings with outside representatives involved in sponsoring or monitoring the planned clinical research. These individuals may include “Sponsors” of planned or ongoing clinical trials, including National Cancer Institute (NCI) personnel, pharmaceutical companies, biotechnology companies, and independent scientific researchers. A Sponsor is an entity which or individual who has assumed responsibility “for initiating, managing, and financing” the trial. A “Sponsor” also oversees the study and analyzes and submits reports about the trial to the Food and Drug Administration.
b) Internal Staff Training and Education. The CTO also uses The Lorax Classroom for the internal training and continuing education of CTO staff, including “Investigators.” An Investigator is “[a] medical professional, usually a physician but [who] may also be a nurse, . . . under whose direction an investigational drug is administered or dispensed. A Principal investigator is responsible for the overall conduct of the clinical trial at his/her site.” The training of Investigators is a critical component of carrying out clinical trials.
2) Certification of Clinical Research Professionals. To provide the most professional management possible for a clinical trial, thus making it more attractive to Sponsors, the CTO encourages its staff to achieve certification as a clinical research professional. Such certification verifies that the individual has displayed a recognizable level of knowledge in clinical research or clinical trials. Clinical research professionals achieve this prestigious designation by taking the certification examinations offered by the Society of Clinical Research Associates (SoCRA), or the Association of Clinical Research Professionals (ACRP).
The CTO will use funds donated by The Triumph Fund and other funds at its disposal to invite SoCRA sponsored educators and trainers to come to MCW to teach a course to prepare the staff for the SoCRA exam and then to administer the certification examination in 2015.
Clinical research staff must have a minimum of two full years of experience in clinical research to be allowed to take the certification examination, therefore we will be offering this opportunity biannually. Because continuing education credits are required to maintain the certifications that have been achieved, the money our donors have contributed to The Triumph Fund will help allow a number of CTO staff each year to acquire the requisite educational materials needed for the certification exams and to travel to SoCRA or ACRP conferences to receive the needed continuing education credits.
3) Expedited Hiring. Donations from The Triumph Fund have helped enable the CTO to expedite the hiring of an “Early Phase Research Nurse/Manager” – also known as a Research Nurse – to usher in more early phase clinical trials to be carried out by the CTO in the TRU. Although the CTO originally expected to fill this position in the next fiscal year, in large part due to the funds donated by The Triumph Fund, this Research Nurse, who has held a supervisory position with a translational research unit in Arizona, has already joined the CTO, thus allowing it to further develop its portfolio of Phase I Clinical Trials.
4) Involvement in NCI Clinical Research Organizations. CTO staff is actively involved in clinical research organizations, including several cooperative groups sponsored by the NCI . The Triumph Fund’s donations support attendance at meetings of these cooperative groups and allow the CTO to maintain leadership roles within the groups.
These efforts continue to promote MCW’s goal of becoming an NCI designated Cancer Center. There are only 68 such Cancer Centers in the country. The NCI’s website explains the numerous advantages to achieving an NCI Cancer Center designation, including increased NCI funding, serious interest shown by national pharmaceutical and biotechnology companies, and increased national prestige.
The cooperative and other groups in which the CTO has ongoing involvement include:
a) National Cancer Institute Cooperative Groups. MCW maintains a membership in four NCI sponsored cooperative groups: i) Alliance ; ii) the ECOG-ACRIN; iii) the NRG; and iv) and the COG (Children’s Oncology Group). These national/ international research networks, called cooperative groups, undertake cancer clinical research primarily under the sponsorship of the NCI. These NCI sponsored organizations are further described in this link: http://www.cancertrialshelp.org/aboutus_content/aboutusMainContent.aspx?intAppMode=5
Each of the three adult groups have either annual or biannual meetings, including specialized meetings for Investigators, Research Nurses, and Research Coordinators of participating cancer centers. Attendees at these meetings receive an update by the disease-specific cancer committees on upcoming clinical trials and the status of current trials for that particular disease. Not only is CTO staff encouraged to take part in these cooperative groups, one of the CTO’s Manager’s for Solid Tumors, Debby Baumgarten, represents MCW as a member of the mentoring and audit committee for NRG. The generosity of The Triumph Fund’s donors helps offset her travel costs and enables the CTO to send at least two other professionals to each meeting. As a result, MCW has a voice at the table of each of these clinical research organizations and the increased respect throughout the country that comes with this ongoing professional involvement
b) The AACI-CRI – a National Leader. Clinical trial operations in this country face a host of issues relating to, among other things, the growing complexity of clinical trials, administrative hurdles, regulatory constraints, increasing staffing, and, not surprisingly, increasing costs. The Association of American Cancer Institutes – Clinical Research Initiatives (AACI-CRI) is a highly-respected network of clinical research leaders that, as it website states, studies and shares best practices that promote the efficient operation of clinical research facilities in cancer centers throughout the U. S. Dr. James P. Thomas, the Medical Director of the CTO, is a founding member and a past chair of this organization. AACI-CRI’s annual meeting primarily involves the leadership of both NCI designated Cancer Centers and the growing and expanding cancer centers, like MCW, which are striving to receive this designation.
Betty Oleson, the Administrative Director of the CTO, in a report to The Triumph Fund, refers to this organization as “the single most collaborative effort I have been part of in the 20+ years I have spent in clinical research.” As she explains, “[w]e have learned a tremendous amount and are beginning to share our own suggestions for improvement as we take a more active role. The organization’s meetings are in Chicago, meaning that the travel costs are relatively minimal. As a result and in large part because of the donations The Triumph Fund has provided, the CTO is sending four members of its leadership team to the annual meeting in July and having representation at each of the breakout sessions.
V. Conclusion: The Triumph Fund is more than satisfied with the “partnership” it has developed with the CTO in terms of the manner in which funds donated to the CTO by The Triumph Fund are being utilized. The Triumph Fund hopes to continue to raise significant funds for the CTO so that the CTO can undertake even more to expedite the movement of life-saving cancer treatments from the laboratory to the patient.