CLINICAL TRIALS INFRASTRUCTURE. New Investigators Course. Andrew Robinson

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1 CLINICAL TRIALS INFRASTRUCTURE New Investigators Course Andrew Robinson

2 Pre-Knowledge: Activation Things to think about: 1. Who is involved in opening/running a clinical trial? 2. What are the requirements of a clinical trial, and what is needed to support this? 3. How is intrastructure (hospital or clinical trial) supported, what are the challenges? Objectives 1. Understand the basic functions of clinical trials infrastructure, so that you can appreciate the unique infrastructure at your centre and the various parts. 2. Develop a sense of timelines typically involved, and the breadth of people involved. 3. Understand the most basic challenge of clinical trials infrastructure, and give some ideas.

3 4. Clinical Trials Infrastructure: A play in two acts: Characters: Gupta An early career lung cancer medical oncologist, who just finished a fellowship in the USA at Dana Farber in thoracic oncology. Rebecca O Shea a 52 yr old lung cancer patient, with T3N2 non small cell lung cancer, otherwise fit.. Lang a clinical trials department (CRA, data entry, CTA, nurse, manager) Regina Merkizer a study monitor Sherlock Jones a NCI auditor. Eddie Money hospital finance Huey Lewis - hospital pharmacy Marie Curie radiation physicist Conn Smythe radiation oncologist Professor X radiologist Act 1, Scene 1: The patient encounter Dr. Gupta Ms. O Shea, you have stage III non-small cell lung cancer, the good news is, it s potentially curable, and you have a 1 in 4 to 1 in 3 chance of being alive in five years. Rebecca Gasp! Dr. Gupta, that doesn t sound very good. You re right Rebecca, we need better treatments. Let me see if we have a clinical trial open. Dr. Gupta leaves the room, and picks up the telephone and calls clinical trials department

4 Hello,, do we have the new MerckizerMSCIG study open yet, using Costalotumab after bi or trimodality therapy in lung cancer? Ummmm, we just got that study 2 weeks ago, we haven t even had our site selection visit yet, we need to get ethics approval are we the provincial applicant for OCREB? they don t meet again until September - we also need the various departments in the hospital- including radiology, and pharmacy to review, and we need to review the budget. That study is also requiring the radiation planning to be standardized, but we have already received the phantom. Then, we need the site initiation visit, the investigators need to be familiar with the protocol and the side effect management, the trial needs global activation, the no objection letter from health Canada.. Ok, so you re saying maybe in a couple of weeks? (taking a deep breath, and muttering under her breath) Investigators love the enthusiasm, need some realism about timelines. Maybe in a couple of months. (to ) Ok, that s great. I think that trial randomizes at the end of therapy anyway, so she ll be completing her surgery in a bout 4 months if she goes for trimodality. Can I speak to her about it now? Can you talk to her about a trial that we don t have open? That doesn t have ethics approval yet? And that isn t open anywhere? Did you PASS the GCP training??? You re just

5 lucky that this is an industry study the time from concept to opening is less than the 18 months to 2 years for cooperative group studies. Ok. Thanks. Heads back to room Rebecca, we don t have any clinical trials open now that you would be eligible for, but when we end treatment, we may have trials open or I may refer you to a center that does have a clinical trial open. Rebecca Ok Dr. Gupta, thank you for looking into that for me. I appreciate knowing what the standard treatment is, and then knowing what the clinical trial options are after that. Act 1: Scene 2: Opening the trial: The scene opens with Regina Merkizer sitting with, and and Conn. Regina Merkizer Ok, thank you for coming to the site selection meeting, we are going to go over the protocol and the eligibility, and I d like to answer these questions, then we ll decide on your eligibility for this trial. That s great. We really would like to open this trial soon. Regina Ok, how many patients do you expect? How will you identify them? What is in place to ensure safety? Have you had similar trials? Is the physics accredited? What barriers do you see in patient accrual? Do you have any competing trials? When do you think you can open?

6 I think we see about 30 patients a year who would be eligible, so should be able to enroll 15. We have no competing trials, we should be ready to open in one month. What he means is there are no competing trials, probably 5-7 per year, and we should be able to open in three months typical is 6 months from receipt to opening. We are working on reducing that. Conn From radiation, we are already accredited with the phantom that was sent, so the QA for the trial has been performed. There is no additional cost to us, so it isn t an issue. We are ready whenever. Regina Great, I ll get back to you, I m sure your site will be selected. Act 1: Scene 3 the opening process, when is this study going to open, Rebecca is almost done her chemorads. Well, with hospital finance, we ve reviewed the budget and approve the CTA. Now pharmacy has to build the protocol in the order entry system and educate the pharmacists still. Huey I ve checked the budget/workload, and we have the special - 70 degree fridge, and we have the log of temperatures. We are ready to receive drug, and just need to put the orders into OPIS. I have vacation coming up though, and I m swamped with clinical work, so I won t be able to put it in the system for a few weeks.

7 And, the hospital/research Institute have signed off. Eddie Money and Chorus We are ultimately liable as the hospital or research institute, and need to sign off and review contracts and budgets. Eddie Money I am also after the department to have a balanced budget. Clinical trials cost money, and we can t continue to subsidize employees if accrual is slow. Unfortunately, clinical trials can only theoretically recoup costs for work done for trials, as most trials pay a start-up fee plus an enrollment fee, but if there is a slow period of accrual, clinical trials staff still need to be paid, even though cash flow in is limited. Clinical trials staff are a fixed cost, but clinical trials revenue are a variable revenue. And, radiology has approved the imaging, and we are already able to send films in the requested format from the radiology reviewers. Professor X We review images and provide an additional local assessment of response and measurements in addition to what the investigator assesses, we require payment for the work these trials generate, we also need to send films sometimes for central review. We have had the clinical trials assistant do the paperwork for the clinical research ethics board review, but you need to approve the revisions to the consent form. The REB next meets the end of this month, so hopefully everything is ready to go.

8 OK, so you need to get ethics approval, budgets approved, investigators educated, pharmacy educated, clinical research staff in-serviced, regimens built in the order entry system, radiation accredited, etc. Did I miss anything? A ton. Wow, thank you clinical trials infrastructure for supporting this. All I want to do is enroll this patient on a trial I guess after the site initiation visit, we ll get going. Act 2: Scene 1: Well Rebecca, you ve finished the radiation therapy and chemotherapy portions of your treatment. I d like to now talk to you about what the standard treatments are, and then speak to you about a clinical trial that we have. Is that ok? Rebecca Yes. Did the chemoradiation work? Is the cancer gone? We have no way of knowing if the cancer is gone or not. There is a chance that it is gone. A CT scan does not help, as we will see white stuff, but it might be scar tissue, it might be tumour, it might be radiation effects. The only way of knowing for sure would be to get in a time machine. The standard treatment is to observe now, and treat if new spots develop or if the mass grows. We will observe for side effects of the therapy, which may happen months later, and we will observe for cancer recurrence.

9 We do have a clinical trial open, that you may be eligible for, where we randomize patients to standard care or to a drug called costalotumab. This drug works by turning on your immune system, and maybe fighting the cancer. I don t get a say in terms of what treatment you get, it is a randomized study. Would you like more information? Yes please. (enters room) Rebecca Hi Rebecca, I m from clinical trials. Dr. Gupta asked me to speak to you about a clinical trial, is that ok? goes through informed consent discussion with patient, who then signs the form. Rebecca So when will I know if I get the drug or not? Well, Dr. Gupta feels that you are eligible for study, and you ve signed consent. Now we need to enter the data to central office to confirm eligibility. Then we call/log into the interactive voice response system thingy. Then the computer will let us know what you are to receive. Rebecca Okey dokey, I hope I get the intervention. Fingers crossed. ACT II Scene 2: 6 months later Dr. Gupta, did you know that your patient on the costalotumab trial ended up in hospital last night?

10 Yes, she was found unconscious and was taken in an ambulance to hospital where she was hydrated and admitted. Her cortisol level was undetectable I think she has panhypopit. She is getting an MRI brain today and an endocrine work-up. Ok, this is a grade 4 toxicity, and we need to report to the sponsor within 24 hrs. I ll get the paperwork started for you. Thank you. What if we find out after the MRI that it isn t, and that she s become adrenally insufficient from her cancer? Then we continue to let the sponsor know as things change. What if she develops another grade 4 toxicity in hospital, that s the result of the intervention given for the grade 4 toxicity from the study drug? Like if she has TB reactivation after receiving infliximab for colitis caused by costalotumab? Ummm, let s not get carried away. If you have questions, speak to the sponsor. Regina will go through all of this data at the next monitoring visit as well. ACT II Scene 3: 4 years later Sherlock Jones Dr. Gupta,, thank you for meeting with me. We are performing an audit of the costalotumab study, to ensure that compliance with ICH-GCP and FDA regulations were followed. Is it ok if we ask you a few questions about the study?

11 Please, we re happy to assist. It might cost a lot, but that s a valuable drug. They paid for my conference trip to Vienna last fall too! MMhhhmmmm. Sherlock What questions do you have. You also have access to all of our documents/source documents etc. We have them stored for just this occasion, and some is in offsite storage but we are happy to retrieve it. Sherlock Ok, do you have the pharmacy logs, including fridge temperature, date shipments received, dates dispensed etc. Yes. Sherlock I ve looked at all the electronic case report forms (ecrfs), and would like the source documentation for a few of them to ensure they were entered correctly, is that ok? Sure. Sherlock As high blood pressure was a potential side effect, do you have your log books for the blood pressure calibration in clinic? Do you have the log books to ensure that weights were correctly assessed, that your scales are accurate? Do you? DO YOU???

12 Wow, it s awesome that audits are so thorough. It does take a lot of clinical trial resources though to make sure we are compliant, have the ethics approval, have the data stored, the forms filled out correctly etc. etc. Between the physical space drug storage, work space, document storage, storage of electronics for patient related outcomes, the personnel involved from contract reviewing/reviewing confidentiality agreements, submitting protocols for review by pharmacy, physics, radiology, finance, laboratory medicine, reviewing the work required from clinical trials staff to consent patients, assess patients, help patients with quality of life assessment, fill out case report forms, follow-up with patients, submitting to ethics locally or provincially or both, ensuring consent language is appropriate locally etc. etc., processing amendments to trials. It seems exhausting. Yes, yes it is. And don t forget dealing with physicians... I don t have time to sign on to xyz, I forgot my password, what do you mean there s another computer system I have to know. Sherlock Oh, you mean the fun part of the job? THE END DISCUSSION 1. What steps need to be taken to open a trial that already is open at another centre in Canada? 2. What physical requirements are there for clinical trials infrastructure that doesn t involve PK/PD/Phase 1 studies? 3. What is the biggest expense in clinical trials other than drugs?

13 4. While infrastructure costs are largely fixed costs (including salary), revenue is variable and depends on accrual. When revenue is variable what are the risks? What ways are there to mitigate those risks? 5. What drives people to overestimate the number of patients they will accrue? 6. If a trial is open globally for 2 years, and it takes you an extra six months to open the study, how much of a return on upfront investment do you lose?

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