NCCTG Spring Meeting April 7-8, 2008 Highlights from the NCCTG New CRA Orientation program: From: Rachel Lei, Clinical Research Associate/Data Cancer Control It was helpful to learn more about cancer control trials since I have not worked with them. “Cancer Control” trials cover prevention (reducing incidence and mortality) as well as symptom management (reducing morbidity). Cancer control accruals are mandated for CCOPs and research bases to keep grant. Some characteristics of cancer control studies: Shorter studies: especially symptom management studies – must be able to work quickly to be of use to patients Extensive use of placebos: since there are usually no “standard treatment” Continuation phases: patients randomized to placebo have option to try investigational agent; continuation phases also assesses duration of benefits of investigational agent Smaller sample sizes: looking for bigger effects Keep the pt on study as much as possible: once a pt has taken even one dose, their data (knowing deviations) is used no matter what happens Self-reported endpoints: because what matters is how the regimen makes the patient feel Areas not considered traditional biomedical treatment: herbs/dietary supplements that have already generated solid animal studies (e.g. known safety profile) and must be readily available and satisfactorily regulated; behavioral/cognitive interventions such as a CD that employs progressive relaxation and imagery to aid sleep NCCTG Website We went through the NCCTG website in great detail. The NCCTG website is probably under-utilized because it is not immediately clear where to go to find certain information. Here are some places on the website for helpful information in the members section: Protocols that randomize through NCCTG are accessed through Protocols (on navigation bar at left), then by either protocol number or specifics of the protocol (i.e. drug abbreviation, type and then disease site). Once on the page of the protocol of interest, the protocol document is accessed by clicking underneath the “additional information” – NCCTG Protocol (in blue text – no apparent button). Under Disciplines, then CRA, is listed many helpful resources for CRAs and coordinators, including: Disease site resource (people) list Quality control specialists for specific protocols contact info CRA manual, which includes instructions for patient transfers and lost to follow-up as well as links to other portions of the website Outstanding materials report (data that are expected and overdue) Calculators (e.g. BSA) used by NCCTG Access to remote data entry and instructions Data Expected and delinquent data can be monitored online through the “outstanding materials report.”   On the list of reports for our membership (Colorado CCOP), there should be a percentage (shown in green) indicating completeness; if this percentage goes under 85% the PI will get a letter from NCCTG Overdue materials are listed by location; you can also see the report for the entire membership by clicking “here” in the first line Within the “materials expected” report, if an item has a negative sign under the “days overdue” column, the number indicates days until the item is overdue Most newer NCCTG protocols require the data to be entered online through the remote data entry system, accessed either from the CRA page or the page of the specific protocol. This system has a number of eccentricities, as listed below:  After you enter in the study number and/or the subject (pt ID number), you must hit Enter (no visible button to press) to trigger the system to prompt you to enter in your user ID and password to load the case Forms are listed under the appropriate phase of study: active treatment, end of active treatment, observation (active treatment has ended but still following X chart test schedule), or event monitoring (no longer following X chart test schedule – FU schedule at physician’s discretion) Once the form of interest has appeared in a separate window, you must work from top to bottom and navigate from one line to the next by pressing Tab. Using a mouse may obscure lines in the form and result in queries. If you need to go away from the form, you may save your work in progress by attempting to “save as complete” (under file at top menu bar) and the system will give you the option of “save as work in progress” and the form will appear red in the original window. NCCTG will not process (or give credit for) the form until it is actually completed and all errors immediately detected by the system have been corrected (in other words, form is no longer appearing red) If changes need to be made within the form, you must work from the bottom up AdEERS Tips on AdEERS:  Never have more than one AdEERS report per cycle – just keep amending the original report even if the event(s) reported have nothing to do with the original event For 24 hr notification reports, the clock begins when you start the report – 3 days to complete. If you don’t have all the necessary info, submit what you have to meet the time frame, and then go back and amend the report when you have more info. Don’t start a 24 hr notification if not required – those not requiring the 24 hour notification you have 7 days to complete and submit the report. When a report is amended, the “last administered date” of the IND agent, attributions to all adverse events, and “description of events” text field must be updated. Reasons NOT to amend AdEERS report Discharge from hospital Recovering to resolved AE Dose reductions Pre-treatment info Notification of “Off study” An AE that continues without resolution (persistent AE), or resolved then occurs during a subsequent cycle (recurring AE) does not require additional reporting by AdEERS unless the grade becomes more severe or hospitalization is associated with the recurring AE. Highlights from the experience of Maribeth Taylor, RN, OCN Overview of Oncology Workshop was our first full day structured seminar, packed with especially helpful content for one, such as I, who is new to Clinical Research. Our speaker, Tammy Neseth, began with the basics, Aspects of Effective Teams. She outlined the importance of an effective team to help build relationships with patients, the IRB, and to augment the collection of effectual data. Each table of 5 came together and collectively discussed our working experience. The table I sat had jointly 44 years of clinical research experience! Our individual input to the class was reinforced throughout the day with a collection of shiny stones for correct answers, or valuable comments. The end prize was exhibited on a table, which would be rewarded to the table with the most stones collected. I was fortunate to be seated at the winning table, yet how to fit my nice prize of a large blanket, cup, and pen into my small suitcase became my pondering challenge. The remainder of the morning addressed Protecting Research Subjects, Research Base Q & A, and a Protocol Review Case Study, all very educational and informative. The afternoon was spent on Phases of Clinical Trials, extensive discussion of Effective Documentation, DARFS, and Drug Accountability. We also referenced throughout the day, as it pertained to our studies, the Good Clinical Practice, Guidance for Industry manual. During the remainder of our days at the conference we visited various training sessions. My favorite was the seminar History of Clinical Neuro-Oncology. The presenter was Anna Willson, a very educated RN. She discussed the progression of early brain tumor treatments, to the current research in brain tumor therapy. I also enjoyed the seminar on Targeted Therapies. It covered a review of the most commonly used targeted therapies, and the management of common toxicities, especially the care of skin rash, which is the most common issue with patients on these drugs. And finally, a favorite subject for all of us, The “Ins and Outs” of an Audit was covered by Tammy Neseth, our instructor from day 1. Her discussion was full of helpful information and tips for those participating in an audit. Covering how to prepare for an audit, common findings at an audit, the importance of adequate documentation, and most importantly, care of the auditors. Tips such as being prepared to begin on time, flagging charts, and providing them with an adequate space to work were just a few of the ideas mentioned. Lastly, our time in Rochester would not have been complete without a tour of the Mayo Clinic. This was an inspiring visit of the largest not-for-profit group practice in the world. They have reportedly treated more than 8 million people since their beginning in the early 1900’s. Their philosophy, the needs of the patient come first, is evident throughout the Mayo community, which was the original vision of Drs. William J. and Charles H. Mayo and their father, Dr. William W. Mayo. Not only did we visit the newest Mayo Clinic building containing the state of the art Cancer Treatment Center, we were given a glimpse back into time at the neighboring historical 1920’s Plummer building which contains a friendship gallery, with photos of many surgeons and physicians who worked with the Mayo brothers. We were allowed to peek into the actual offices of each of the Mayo brothers as they left them. We also saw the original desk of the father Mayo, and the huge Board of Governors Room with more than 200 awards, citations, and honorary degrees that the Mayos received. During our tour we had glimpses of Mayo’s recognition of nursing. Not only is the Mayo clinic a magnet hospital, but early appreciation toward nurses was represented in the stone carvings atop the tower of the old Plummer building. Another beautiful art piece adorns the main corridor of the hospital titled, Forever Caring. Figures of nurses are arranged to portray the retrospective histories of nurses from past, present, and future meeting patient care needs. Also, as part of the tour we saw many other amazing and famous pieces of art which have been donated to the hospital from former patients and benefactors, all wonderful and inspiring. Giant blown glass chandeliers and an extensive 2 wall mural depicting the individual lives of the brother’s Mayo greet patients and visitors as they enter the Mayo Clinic. Although overwhelming, this building feels extremely welcoming. I left Minnesota motivated to make a continued effort of integrating the inspirational Mayo philosophy into the care of my patients, and feeling more educated to do my small part toward the advancement of Oncology research. Thank you to CCRP and my colleagues at North Colorado Medical Center for giving me this opportunity.