1	Considerations in Industry Sponsored Clinical Trials Lori Kelly, RN BSN Clinical Trials Coordinator
2	Why do Industry Sponsored Clinical Trials? Opportunity for new investigators to get their “feet wet” in a non-threatening setting by working as a sub-investigator. Provide income to department for support of non-sponsored research. Be involved in new modalities and device development. (Use experience to enhance image as a local expert in the field) Establish APOM as clinical research site within the Pharmaceutical Industry. Participate in industry publications if our site is a good enroller.
3	Industry Sponsored Trials Different from Investigator-initiated trial: Sponsor (Pharmaceutical company/Device company) designs and writes the protocol Sponsor “owns” the data generated Investigator is bound by contract to follow protocol unless mutually amended Sponsor will be very involved-the FDA is monitoring them
4	"Study coordinator" Study coordinator/ Research associate may be needed to manage study documents and work with the sponsor. OHSU will manage the legal contracts through SPA and takes its share! Sponsor has no relationship with the patient, indeed no direct identifier is given to the sponsor. Sponsor may provide all study related devices, lab materials, lab processing, etc.
5	Who’s Who? Principal Investigator (PI) Sub-investigator Study Coordinator: Research Nurse/Associate Sponsor Clinical Research Organization Monitor/CRA Medical Monitor
6	Principal Investigator “Top Dog” Responsible for all conduct of the clinical trial at the study site as outlined in the Code of Federal Regulations Assigns responsibility for the other members of the team Ensures the accuracy of the data that are submitted. Makes medical assessments related to the protocol and determines whether adverse events are study related or not.
7	Sub-investigator Assumes responsibility of patient care assessments but not responsible for administrative issues of the trial
8	Study Coordinator/Research Nurse or Associate May be the same person Manages the day-to-day logistics of everything Helps assess study feasibility Understands federal regulatory issues and document management Meets with the sponsor’s monitor on a regular basis
9	Other members of the team… On site: Research Pharmacist, APOM Research Administrator From Sponsor: Monitor (regular visits to check data, maintain regulatory documents, determine payment) Medical Monitor (physician on call to answer protocol questions or safety issues)
10	Other…. Contract research organization (CRO). (As if there weren’t enough “chiefs”) The CRO works as a broker for the Pharmaceutical Company to manage the administrative aspects of the clinical trial. The CRO provides monitors and data management. They may also be involved in study site selection.
11	If you want to be an investigator… You must have time to do the study Your must be sure you can meet the recruitment targets You should not have any competing trials You must be aware of and adhere strictly to the Investigator’s Good Clinical Practice responsibilities (Code of Federal Regulations Title 21 part 312)
12	What makes an Ideal Clinical Investigator? (from the sponsor viewpoint) Fast High quality Cheap
13	What are sponsors looking for? Evidence that the right patient population exists Credentials and experience of the investigator and staff IRB turnaround time Ongoing conflict or competing studies? Enthusiastic and committed PI and staff Willingness to follow GCP guidelines and the sponsor SOP’s
14	More…. Facilities (lab, secure storage, x-ray, fax, space for monitor visits) Obsessive-compulsive, attentiveness to details. General atmosphere
15	Why would a Sponsor pick us? Academic Medical Center: We provide a solid patient data base and proven research expertise. Large pool of available subjects Convenient site accessible for monitoring Fantastic investigators and incredible study personnel!
16	Initial Contact
17	Getting started Contact from the sponsor usually starts with a query from the sponsor or their representative CRO whether you are interested in a study. A Confidential disclosure agreement (CDA) will be sent for your signature. Send it to Diane Brownlee, JD Contract analyst before you sign. This must be done before they will send further information about the study. There is no obligation to participate, this is just getting to know each other.
18	More… The sponsor may request site information such as PI CV, type of patients, number of patients. They are looking to see if you meet their basic criteria. If both parties are interested, a site qualification visit is arranged. The sponsor representative will discuss the protocol in general, tour the facility, interview the study staff, get a general feeling of the site.
19	Site Qualification Visit We get to interview the “sponsor” also! General information about the proposed trial is shared, sometimes the proposed protocol is discussed. Important that the intended PI is available to meet with the sponsor. (Shows involvement) Include study personnel (impress them with our resources)
20	And more… Include Research Administrator (bring up proposed per/patient payout?) Sponsor may want to view the lab, pharmacy, storage areas, patient areas where recruitment may take place. If the sponsor feels our site is appropriate for the study, the protocol may be sent, regulatory documents requested (FDA forms, financial disclosure forms, copies of licenses, CV’s.), and a proposed budget.
21	Still not home free… The Protocol must be assessed for feasibility and the sponsor’s proposed budget must be assessed for financial viability by our research adminstration.
22	Protocol Assessment-Things to consider Is the enrollment goal realistic for your time, patient population? Are the inclusion/exclusion criteria too restrictive? Will the IRB have problems with any aspect of this protocol? How many persons must be involved in the study (MD, blinded safety assessors, study staff) How much follow-up for each subject is required?
23	All Aboard! Investigator meetings at sponsor expense to discuss the protocol with all PI’s . Protocol may be amended after meeting requiring re-submission to IRB and consent changes. Sponsor will give the go-ahead to enroll subjects when trial ready to start. Study delays may last several months!
24	Some harsh realities… Things don’t always go as planned, ie. lack of appropriate subjects, study extensions. Assume the IRB will have issues with the protocol, consent, patient hand-outs. Think about problems and plan budget accordingly. Talk to experienced study staff.
25	In Summary It is an adventure to be involved in industry sponsored clinical trials but it’s not for the naïve or faint-hearted! Go forward with eyes wide open. Recognize the pitfalls, try to plan for them Be sure the protocol is do-able Be sure the pay-out is worth the time involved!
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29	Phases…. Phase IV: The drug has been FDA approved and is undergoing further safety data study. Or drug maker is trying to expand the approved uses or targeting different populations.
30	Phases of Drug Development Phase I: Small group (20-100) healthy volunteers are given the study drug to test its safety, tolerability, and pharmacokinetics and pharmacodynamics Phase II: Efficacy for the drug’s intended use and best doses for target indication. Subjects might be ill and dose/agent is untested in sick people. May include placebo or comparator drugs. Phase III: More people (multi-site) included, more underlying medical diseases. Usually compared to placebo or existing treatment or drug.