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Sandra Maddock OMTEC Presentation 6-12
 

Sandra Maddock OMTEC Presentation 6-12

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    Sandra Maddock OMTEC Presentation 6-12 Sandra Maddock OMTEC Presentation 6-12 Presentation Transcript

    • Running a Clinical Trial: How to Navigate the Regulatory Maze Presented by: Sandra Maddock, RN, BSN, CCRA President & CEO, IMARC Research, Inc.We have studied clinical research and regulatory compliance issues since 1999.
    • In the next hour…Discuss current FDA climate and the impact that has on the orthopaedic industry Identify regulations that govern clinical research and discuss the importance of having a solid regulatory basis for decisions made in the clinical research setting Apply regulations to real-world scenariosSandra Maddock
    • Our Focus: ClinicalDevelopment Design/Prototype Validation/Verification Preclinical Testing Clinical Regulatory ClearancePost Market Activities Sandra Maddock
    • Our Focus: Clinical ClinicalResearch involving humansubjects….Sandra Maddock
    • Current FDA Climate• 2009: 510(k) evaluation – Institute of Medicine Report – Internal FDA Committee Report• 2011: FDA releases DRAFT 510 (k) Guidance – Clinical data required in approximately 10% of submissions • New indication for use • New technology • Limitations of non-clinical testing methods Sandra Maddock
    • Current FDA ClimateJanuary, 2012 –“Device industry watchers say FDA’s newoverarching draft guidance on the 510(k)pre-market review program introduces newconcepts that may add confusion, not clarity,to device makers planning to bring newproducts to market.” Sandra Maddock
    • Current FDA Climate“(FDA changes) could result insignificant disruption to aprogram that has served patientswell for more than 30 years.”Quote from AdvaMed Sandra Maddock
    • Impact on Orthopaedic Industry • Stalls innovation – Unclear processes • More clinical data required – 510 (k) • More scrutiny – Increase in number of warning letters – Inspections happening “real-time” Sandra Maddock
    • Impact on Orthopaedic Industry FDA Steps Up Scrutiny of Metal Hip Implants March 30, 2012 FDA cites orthopedic medical device company over violations April 24, 2012 Many medical implants never tested for safety, Consumer Reports says April 18, 2012 Sandra Maddock
    • Let’s Shake Things UpSandra Maddock
    • “You can fool all of the people some of the time, andsome of the people all of the time, but you cannotfool all of the people all of the time.” - Abraham Lincoln Sandra Maddock
    • You Need To Bring It!Sandra Maddock
    • What You Need to Know21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs;AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR Sponsor CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; 11; 21SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812;Good CFR 11; 21 CFR 50; 21 CFR 54; 21 Internal Requirements 21 Clinical PoliciesCFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; Practice21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITESOPs; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITESOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; FDASPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR IRB Regulations 50; 21 CFR 54; 21 RequirementsCFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; CRO/ Research21 CFR 50; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE Monitor Sponsor SiteSOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs;SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; NIH21 CFR 50; 21 CFR Guidelines CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE 812; 21 ICH GuidelinesSOPs; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITESOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 CFR 56; ICH; IRB SOPs;SPONSOR SOPs; SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11; 21 CFR 50; 21 CFR 54; 21 Protocol ISO14155CFR 56; ICH; IRB SOPs; SPONSOR SOPs; SITE SOPs; AGREEMENTS;Requirements Investigator PROTOCOL; 21 CFR 812; 21 CFR 11;21 CFR 50; ICH; IRB SOPs; SPONSOR SOPs; SITE Agreements SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 21SPONSOR AND SITE SOPs; AGREEMENTS; PROTOCOL; 21 CFR 812; 21 CFR 11;IRB SOPs; It’s Complicated! Sandra Maddock
    • Adding To The Mix… Fixed versus Variable A decision about regulatory compliance made at one site forone study may not be the right decision at another site for the same study or at the same site for another study…. Sandra Maddock
    • Sandra Maddock
    • 21 CFR 812 - IDEs • 812.110: An investigator shall conduct an investigation in accordance with the signed agreement with theInvestigator sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA. • 812.46: (paraphrased) Ensuring compliance with Sponsor signed agreement, investigational plan, applicable FDA regulations, and IRB requirements.... Sandra Maddock
    • Working through the maze Federal Regulations Agreements Investigational Plan Requirements of IRBSandra Maddock
    • Federal Regulations• Requirements for conducting clinical studies• Outlines responsibilities of the sponsors, investigators, and IRBs for conducting trials involving human subjects
    • Federal Regulations FDA Regulations to Know812 IDEs (Investigational Device Exemptions)50 Protection of Human Subjects56 IRBs (Institutional Review Boards)54 Financial Disclosures11 Electronic Records/Signatures Sandra Maddock
    • Federal Regulations21 CFR 812 - IDEs • Describes the procedures for the conduct of clinical investigations of devices • Sponsor responsibilities • Investigator responsibilities Sandra Maddock
    • Federal Regulations 21 CFR 812 - IDEs • 812.110: An investigator shall conduct an investigation in accordance with the signed agreement with theInvestigator sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA. • 812.46: (paraphrased) Ensuring compliance with Sponsor signed agreement, investigational plan, applicable FDA regulations, and IRB requirements.... Sandra Maddock
    • Federal Regulations 21 CFR 812 - IDEs• Overall conduct of a study: – Labeling – Promotion – Selection of Investigators – Monitoring (securing compliance) – Record keeping – IRB approval….. DOCUMENT IT! Sandra Maddock
    • Federal Regulations 21 CFR 50 – Human Subject Protection• The rights, safety, and well-being of the trial subjects should prevail over interests of science and society.• Freely given Informed Consent should be obtained from every subject prior to clinical trial participation.• The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality Sandra Maddock
    • Federal Regulations21 CFR 50 – Human Subject Protection • Specifies: – Consenting procedures – Elements to include in an informed consent – Documentation of informed consent – Exceptions of informed consent – Safeguards for children/wards Sandra Maddock
    • Federal Regulations 21 CFR 50 – Human Subject Protection• Sponsor obligations: – Ensure informed consent process at site level is compliant with regulatory requirements DOCUMENT IT! Sandra Maddock
    • Federal Regulations 21 CFR 56 - IRBs• IRBs – Institutional Review Boards (Ethics Committees) Review and approve research studies involving human subjects• 21 CFR part 56 contains general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA Sandra Maddock
    • Federal Regulations 21 CFR 56 - IRBsAn IRB has the authority to: • Approve research • Require modifications in research • Disapprove research • Require additional elements of informed consent are provided • Waive the requirement for a signed informed consent Sandra Maddock
    • Federal Regulations 21 CFR 56 - IRBs• Sponsor’s obligations: – Ensure IRB is operating in compliance with 21 CFR 56 – Ensure site is following IRB procedures DOCUMENT IT! Sandra Maddock
    • Federal Regulations 21 CFR 54 – Financial Disclosure• Protect the integrity and reliability of clinical data• FDA considers whether adequate steps are taken in the design, conduct, reporting and analysis of studies to minimize bias• The FDA works with the applicant/sponsor to minimize potential bias Sandra Maddock
    • Federal Regulations 21 CFR 54 – Financial Disclosure Investigator to Sponsor to FDA SponsorIf financial interests raise questions about data integritythe FDA may: • Initiate audits of the data from that investigator • Request further analyses of data • Request applicant to conduct additional studies • Refuse the data Sandra Maddock
    • Federal Regulations 21 CFR 54 – Financial Disclosure• Sponsor’s obligations: • Collect accurate investigator financial information before study participation (21 CFR 812.43) • Report COI to FDA at time of application • Obtain updates throughout the study and for one year after all study data is submitted DOCUMENT IT! Sandra Maddock
    • Federal Regulations21 CFR 11 – Electronic Records • Describes How: – Electronic records, electronic signatures, and handwritten signatures executed to electronic records are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. Sandra Maddock
    • Federal Regulations 21 CFR 11 – Electronic Records• To ensure the authenticity, integrity and confidentiality of electronic records, controls include: – Tracking of data entry with an audit trail (paper or electronic) – Documented verification of data entry accuracy – Unique electronic signatures Sandra Maddock
    • Federal Regulations 21 CFR 11 – Electronic Records• Sponsor’s obligation: – Know the requirements of 21 CFR 11 – Ensure site and internal (sponsor) compliance DOCUMENT IT! Sandra Maddock
    • Minute to Win It!Sandra Maddock
    • Fill in the blanks….Regarding record maintenance, an investigator mustmaintain accurate, complete and current records,including:21 CFR 812.140 (1)All _____________ with another____________, an _______, thesponsor, a monitor, or ______,including required________________.
    • Working through the maze Federal Regulations Agreements Investigational Plan Requirements of IRBSandra Maddock
    • Agreements• Statement of investigator’s commitment to: – Conduct the investigation in compliance with FAIR – Supervise device use – Obtain informed consent – Other items as agreed upon with sponsor… DOCUMENT IT! Sandra Maddock
    • Working through the maze Federal Regulations Agreements Investigational Plan Requirements of IRBSandra Maddock
    • Investigational Plan • Inclusion / Exclusion • Required Testing • Procedural Requirements • Randomization Processes • Follow-up Requirements DOCUMENT IT! Sandra Maddock
    • Working through the maze Federal Regulations Agreements Investigational Plan Requirements of IRBSandra Maddock
    • Requirements of IRB • Informed consent procedures • Adverse event reporting requirements • Renewal timelines • Etc. Sandra Maddock
    • Case Maze Study #1 You are monitoring a site when you notice that an investigator routinely signs the consent forms days after the patients sign them. You’re not sure what to do. The manager of the brand new research coordinator tells you that this is no big deal and there is nothing to address. She said “It’s not in the regs…..” Is she right?Sandra Maddock
    • Working through the maze Federal Regulations Agreements Investigational Plan Requirements of IRB  Could be specified by the IRBSandra Maddock
    • Maze Study #2 A monitor notes that all of the IRB approvals were on file at a site, but some of the correspondence back and forth regarding the approvals was missing. The RC refused to locate the missing documentation. The monitor insists “It’s in the Regs….” Is the monitor correct?Sandra Maddock
    • Working through the maze Federal Regulations FDA requires that all correspondence with an IRB be maintained (21 CFR 812.140) Agreements Investigational Plan Requirements of IRB Sandra Maddock
    • Maze Study #3 You have a site that routinely takes case report forms (CRFs) into the exam room while seeing patients. While much of the information you need for the study is included in the patient’s regular assessment, they write the other data directly onto the CRF. You think they need a separate source, but you’re not sure. You dig into the regulations and find what???Sandra Maddock
    • Working through the maze Federal Regulations Agreements  Could be in an agreement  Could be in an Investigational Plan investigational plan Requirements of IRBSandra Maddock
    • Well?????Discuss current FDA climate and the impact that has on the orthopaedic industry Identify regulations that govern clinical research and discuss the importance of having a solid regulatory basis for decisions made in the clinical research setting Apply regulations to real-world scenariosSandra Maddock
    • Sandra Maddock CEO and President Meet Our Team John Lehman Mary LewisDirector of Business Development Clinical Auditor & Research Associate Sandra Maddock
    • More Information for You on Download our Whitepaper Sandra Maddock
    • References• FDA’s official website: • www.fda.gov• GCP Guidances and Information Sheets • http://www.fda.gov/oc/gcp/guidance.html• Informed Consent • A Guide To Informed Consent: • http://www.fda.gov/oc/ohrt/irbs/informedconsent.html • Protection of Subjects: • http://www.fda.gov/cdrh/devadvice/ide/informed_consent.shtml• Running clinical trials • http://1.usa.gov/ILt1tc Sandra Maddock