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PBHLTHX400.2-068 Introduction to Clinical Research: Clinical Trial Phases and Design > Final Exam_18Oct2021 > Flashcards

Final Exam_18Oct2021 Flashcards

1
Q

Q

A

Answer

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2
Q

Explainthe preclinical (nonclinical) phases from a scientific and business point of view

A

Scientific point of view:
-Determine safe initial dose to be used in Phase 1 human trials

Business Point of View:
-Key business decisions need to be made regarding the potential market size, the company’s prior expertise with that disease area, and the anticipated financial return or return on investment of bringing that drug to market.

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3
Q

Define the purpose of the New Drug Application (NDA) and state where in the process it would be filed

A

The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:

1) Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
2) Whether the drugs proposed labeling or package insert is appropriate, and what it should contain.
3) Whether the methods used in the manufacturing of the drug and the controls used to maintain the drugs quality or adequate to preserve the drugs identity, strength, quality, and purity.

It is filed after phase 3 clinical trials.

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4
Q

List typical desired outcomes of a clinical trial phase 4

A

Phase 4 clinical trials are post-marketing studies conducted to delineate additional information, including the drug’s

  • risks
  • benefits
  • optimal use.

These studies may be required by the FDA as a contingency for market approval.

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5
Q

True or False - Although a drug’s toxicology profile is a goal of preclinical studies, toxicology information is continuously gathered throughout all phases 1–4.

A

TRUE

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6
Q

A blockbuster drug is defined as:

A

A drug that generates more than $1 billion in revenue annually

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7
Q

What FDA division oversees the drug development of the influenza vaccine?

A

The Center of Biologics and Research (CBER)

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8
Q

Early safety tests provide data that the drug can be:

A

Absorbed in the bloodstream

Distributed to the proper site of action in the bloodstream

Excreted from the body

Metabolized effectively and efficiently

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9
Q

Optimal lead compound identification is where:

A

The target is impacted by the drug

The target is involved in the disease

The target is well understood

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10
Q

An ideal lead compound is:

A

Selective

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11
Q

The IND application does NOT include:

A

Marketing Strategy

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12
Q

Which of the following are included in the IND application?

A

Clinical information from outside the United States

Form FDA-1571

Investigator’s Brochure

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13
Q

Target identification is the process of selecting a particular gene, protein, or receptor involved in the disease that has the potential to be impacted by the drug.

A

TRUE

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14
Q

A prospective study measures outcomes by:

A

Following research subjects from a point today and into the future

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15
Q

According to GCP, the two principles of clinical research are:

A

Protection of human subjects and scientific and ethical quality standards

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16
Q

Which one of the following is NOT a principle of ICH-GCP?

A

Compensation

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17
Q

Before approval of a product for marketing by a regulatory authority, manufacturers may have to prove its:

A

Safety and Efficacy

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18
Q

A clinical trial is:

A

An experiment on humans

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19
Q

A clinical trial is conducted according to:

A

A:
An investigational plan or protocol

Applicable regulations

Ethical principles

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20
Q

A product is said to be in investigational use when:

A

A new dosage form is being administered

It has not been approved by the regulatory authority in the location of use

It is being used for a different indication than its approved use

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21
Q

The thalidomide tragedy resulted in the FDA requiring:

A

Proof of the safety of the drug

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22
Q

The ICH Guidelines for Good Clinical Practice came about as a result of:

A

Harmonisation of international standards

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23
Q

Good Clinical Practice (GCP) applies:

A

When a trial with an investigational product is being conducted on humans

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24
Q

All countries follow the same set of GCP standards and regulations.

A

FALSE

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25
Q

What ensures protection of the rights of human subjects?

A

Accurate and verifiable data.

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26
Q

The FDA is organizationally placed in the Department of Health and Human Services (HHS).

A

TRUE

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27
Q

The FDA does NOT regulate which one of the following products?

A

Ground Beef

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28
Q

What types of products does the FDA regulate?

A

Antiperspirant, aspirin, cereal, cigarettes, laser pointers, viagra

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29
Q

Drug development is guided by:

A

Good Clinical Practice (GCP)

Good Laboratory Practices (GLP)

Good Manufacturing Practice (GMP)

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30
Q

Once a new drug is approved for marketing by the FDA, it cannot be withdrawn from the market.

A

FALSE

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31
Q

FDA implements its statutory public health protection mission by:

A

Conducting inspections

Evaluating safety reports regarding regulated products

Overseeing approvals of drugs, biologics, and medical devices

Taken enforcement actions against adulterated drugs

Taking enforcement actions against misbranded drugs

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32
Q

FDA inspects the following types of establishments as part of its Bioresearch Monitoring Programs:

A

Clinical Investigators

IRBS

Nonclinical Labs

Sponsors of clinical trials

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33
Q

ICH Stands for:

A

International Council for Harmonisation

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34
Q

The ICH has as one of its objectives to prevent the duplication of unnecessary human clinical trials.

A

TRUE

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35
Q

The ICH Regulatory Membership is composed only ofthe authorities fromthe USA, Japan, and the EU.

A

TRUE

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36
Q

ICH Guidelines are divided into the following categories.

A

Efficacy, Multidisciplinary, Quality and safety Guidelines

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37
Q

Of the four types of Guidelines that the ICH publishes, the one most applicable to clinical research work is:

A

Efficacy

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38
Q

What is MedDRA?

A

ICF Medical Terminology

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39
Q

An investigational drug is a:

A

Biological product used in vitro for diagnostic purposes

Drug not yet approved by the FDA to be marketed in the United States

New drug or biologic used in a clinical investigation

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40
Q

The Pre-IND Consultation Program:

A

Allows the FDA to determine if the clinical study design is scientifically valid

41
Q

The 1962 Kefauver-Harris Amendment to the Federal FD&C Act:

A

Required that drug manufacturers prove safety and effectiveness prior to marketing a drug

42
Q

The following are included in the IND EXCEPT:

A

Projected return on investment

43
Q

The Investigator’s Brochure includes:

A

A brief description of the drug substance and and drug product formulation

A summary of all preclinical data related to the drug substance

A summary of safety and effectiveness in humans, if applicable

44
Q

A Phase 1clinical trial usually focuses on all of the following EXCEPT:

A

Efficacy

45
Q

A treatment IND is:

A

A request to FDA to use an investigational drug prior to marketing approval

Used for patients with serious or immediately life-threatening conditions

Used when no alternative treatment is available

46
Q

What is the primary goal of nonclinical studies?

A

Provide dosing and exposure information for clinical trials

Provide ADME data for at-risk populations

47
Q

Which of the following is NOT a key objective of a clinical trial?

A

Identify off-label indications

48
Q

What are the key objectives of a clinical trial?

A

Identify therapeutic efficacy

Obtain safety and tolerability data

Provide data for label development

49
Q

Some key endpoints of a successful Phase 1 clinical trial are:

A

ADME data, drug is reasonably well tolerated, and drug is tolerated upon multiple administrations

50
Q

Some key endpoints of a successful Phase 2 clinical trial are:

A

An optimum dose range is determined

Effects of concomitant medications are understood

Maximum tolerated dose is determined

51
Q

Some key endpoints of a successful Phase 3 clinical trial are:

A

A draft package insert and label are ready for submission as part of an NDA

Conclusive evidence to support the use of the drug for treatment of a certain disease or condition

52
Q

Some keyendpoints of a successful Phase4 clinicaltrial are:

A

Expanded indication or extension of the label

Inclusion of range of age groups, races, and/or severity of disease

53
Q

ide effects of the drug in patients are usually determined in which phase?

A

Phase 2

54
Q

What are 1571s?

A

Investigational New Drug Application

55
Q

What are 1572s?

A

AKA Statement of Investigator. The purpose is to inform the sponsor that the investigator is qualified, and the clinical site is an appropriate location for clinical investigation and to inform and clarify the obligations of the investigator and to acquire investigator’s commitment to follow pertinent FDA regulations.

56
Q

What must be included in an Informed Consent?

A

The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by him/her, so that he/she can make the voluntary decision regarding “to” or “not to” participate in the research study.

57
Q

IND Approval Times

A

An IND application may go into effect:
30 days after FDA receives the application, unless FDA notifies the sponsor that the investigations described in the application are subject to a Clinical Hold; or.

on earlier notification by FDA that the clinical investigations in the IND may begin.

58
Q

Investigator responsibilities in clinical trials?

A

1) Electing qualified investigators and providing them with the information they need to conduct an investigation properly
2) Ensuring proper monitoring of the investigation(s)
3) Ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND
4) Maintaining an effective IND with respect to the investigations
5) Ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug.

59
Q

List the primary responsibilities of an IRB or IEC.

A

Reviewing and approving all clinical trial protocols and amendments

Reviewing and approving the methods and materials used to obtain and document informed consent of trial subjects

Reviewing all clinical study related materials—including subject information, informed consent forms, subject recruitment procedures, written information for subjects, subject payments and compensation, and safety information—both before the start of the trial and throughout the conduct of the trial (at least once a year)

Ensuring the investigators and all study staff are qualified with sufficient experience in Good Clinical Practice (GCP) and the designated therapeutic area being studied in the trial

Complying with national and/or local regulations, as well as with ICH good clinical practice guidelines

60
Q

When would an investigator use a central IRB instead of a local IRB?

A

A central IRB tends to have access to more resources, staff, and expertise than a local IRB. Therefore, an investigator would use a central IRB to review multicenter trials that involve complex study designs and larger numbers of subjects.

61
Q

Describe the membership requirements of an IRB or IEC.

A

An IRB/IEC should have:

At least five members
Members with varying backgrounds (diversity of race, gender, and culture)
At least one member whose primary area of interest is nonscientific (a layperson)
At least one member who is independent and is not affiliated with the institution or the trial site
Competent members who are able to review and evaluate the science, medical aspects, and ethics of the proposed trial

62
Q

Would a clinical trial that involves an abdominal surgical procedure require a full, expedited, or exempt IRB/IEC review?

A

A clinical trial involving an abdominal surgical procedure would require a full IRB/IEC review because of the greater than minimal risks.

63
Q

What must a research study demonstrate in order to be approved by an IRB/IEC?

A

In order to gain approval from an IRB/IEC, a research study needs to demonstrate the following:

The benefits outweigh the risks

The protocol design includes sound scientific methods

The intervention being studied is compared with established standards for treatments

The selection of subjects is equitable
Informed consent is obtained from all subjects

Data is monitored

The privacy of subjects is protected

There are additional safeguards to protect vulnerable populations from undue influence

64
Q

Describe the type of communication that takes place between an IRB/IEC and:

A) An investigator
B) Regulators

A

A) The IRB/IEC is responsible for communicating its concerns and complaints to the investigator. The IRB/IEC will inform the investigator that no subject may be admitted to a trial without its approval of the protocol. The investigator must also communicate to the IRB/IEC any deviations and violations that occur from the approved protocol, any serious and unexpected adverse drug reactions that occur during the course of the trial, and any new safety information that the investigator receives about the study from the sponsor.

B) The IRB/IEC is required to communicate to a regulatory authority any serious or continuing noncompliance by an investigator in regard to all applicable regulations and IRB policies. Each IRB/IEC in the United States that reviews an FDA-regulated study must register with the FDA. This requirement provides the FDA with a comprehensive listing of all U.S.-based IRB/IECs responsible for reviewing FDA-regulated research. IRBs/IECs based outside of the U.S. that review FDA-regulated research can choose to voluntarily register.

65
Q

What does an investigator have to agree to in order to comply with the conduct of a clinical trial?

A

In order to comply with the conduct of a clinical trial, the investigator should agree to the following:

Compliance with GCP and all applicable regulatory requirements

Monitoring and auditing of the conduct of the clinical trial by the sponsor

Inspection of the clinical trial and site by the appropriate regulatory authority

Maintaining a list of qualified persons who have been delegated significant clinical trial related responsibilities

66
Q

When does an investigator communicate:

A) With the IRB/IEC?
B) With the regulatory authority?

A

A) Before initiating a clinical trial, the investigator should have written approval from the IRB/IEC for the clinical trial protocol, informed consent form, subject recruitment procedures, and any other information provided to the subjects. During the clinical trial, the investigator should continue to provide the IRB/IEC with all related documents for review.

B) The investigator should only communicate with the sponsor and the IRB/IEC. The only exception is if the site is audited. Then investigators are required to permit the FDA to inspect and copy any records pertaining to the investigation.

67
Q

Describe an investigator’s responsibilities related to the investigational product.

A

The investigator is ultimately accountable for the investigational product but may delegate this responsibility to a qualified person.

Adequate records of the investigational product’s delivery to the trial site, inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s) must be maintained including dates, quantities, batch/serial numbers, expiration dates, and codes assigned to the product(s) and trial subjects.

The investigational product should be stored as specified by the sponsor and in accordance with all regulatory requirements.

All investigational products should be used in accordance with the approved protocol.

The investigator should explain the correct use of the investigational product to each subject.

68
Q

What should an investigator do if a clinical trial is prematurely terminated or suspended?

A

If the trial is prematurely terminated or suspended, the investigator should inform the subjects. An appropriate therapy and follow-up should be identified for the subjects.

If the investigator terminates or suspends a trial without prior agreement of the sponsor, the investigator should inform the institution where the trial is being conducted and provide the sponsor and the IRB/IEC with a detailed written explanation of the termination or suspension.

69
Q

Describe an investigator’s responsibilities related to obtaining a subject’s informed consent.

A

The investigator should comply with all applicable regulatory and GCP requirements related to obtaining a subject’s informed consent.

Before the start of the clinical trial, the investigator should have the IRB’s/IEC’s written approval of the informed consent form and any revisions.

No subject should be coerced into participating or continuing in a clinical trial.

The language used in the informed consent form should be as nontechnical as possible.

70
Q

Who is responsible for finding out if an investigator has been debarred before the start of a clinical trial? Where is this information publicly available?

A

The sponsor is responsible for finding out if an investigator has been debarred before the start of a clinical trial. A list of disqualified, restricted, or debarred investigators is publicly available on the FDA website.

71
Q

What is a sponsor?

A

The FDA identifies the sponsor as an individual, pharmaceutical company, governmental agency, academic institution, private organization, or other organization who is responsible for a clinical trial but does not actually conduct the investigation.

ICH identifies a sponsor as an individual, company, institution, or organization with the responsibility to initiate, manage, and/or finance a clinical trial.

72
Q

Who is ultimately responsible for the conduct of a clinical trial?

A

The sponsor is ultimately responsible for the conduct of a clinical trial.

73
Q

What purpose does an IDMC or DSMB serve?

A

An Independent Data Monitoring Committee (IDMC), also known as a Data and Safety Monitoring Board (DSMB), assesses the progress of a clinical trial while maintaining the study’s blinding. The safety and efficacy data are unblinded and reviewed at critical intervals according to written operating procedures. The IDMC/DSMB then recommends to the sponsor whether to continue, modify, or stop the clinical trial.

74
Q

What does IDMC stand for?

A

Independent Data Monitoring Committee

75
Q

What does DSMB Stand for?

A

Data and Safety Monitoring Board

76
Q

What are some of the sponsor’s responsibilities in managing an investigational product in a clinical trial?

A

The sponsor should ensure that sufficient safety and efficacy data from nonclinical studies and/or clinical trials supports human exposure (route of administration, dosage, duration of exposure, etc.) in the population to be studied.

The sponsor should update the Investigator’s Brochure as new information becomes available.

The sponsor should ensure that the investigational product(s), active comparator(s), and placebo (if applicable) are appropriate for the stage of development, manufactured according to GMP, and labelled to protect study blinding (if applicable).

The sponsor should determine and inform study personnel of the proper handling procedures, storage (temperature, conditions, times, etc.), dispensing, retrieval, and return of the investigational product(s). Any unused product should be returned to the sponsor or disposed of according to the sponsor’s instructions.

The sponsor should package the investigational product(s) to prevent contamination and deterioration during transportation and storage.
The coding system for the investigational product(s) in a blinded clinical trial should permit rapid identification of the product(s) in case of a medical emergency.

The sponsor is responsible for providing the investigator with sufficient quantities of the investigational product(s) after IRB/IEC approval has been obtained.

The sponsor should maintain documentation related to shipment, receipt, disposition, return, and destruction of the investigational product(s).
The sponsor should maintain a system for retrieving investigational products in the event of a product recall.

77
Q

Who submits a marketing application to the regulatory authority?

A

The sponsor submits a marketing application to the regulatory authority.

78
Q

Give several reasons why a regulatory authority would force a sponsor to prematurely terminate a clinical trial.

A

A regulatory authority might force a sponsor to prematurely terminate a clinical trial for one of the following reasons:

Inadequate protocol design where subjects are exposed to unreasonable and significant risk of injury or illness.

Inadequate protocol design where insufficient information is collected to properly assess safety of subjects.

Inadequate manufacturing controls of the investigational product.

Noncompliance with the protocol, SOPs, GCP, sponsor agreement, and/or applicable regulatory requirements by an investigator or clinical trial staff member.

Monitoring and/or auditing identifying serious and/or persistent noncompliance by the investigator such as failure to report serious and unexpected adverse events.

79
Q

What is a CRO?

A

A contract research organization (CRO) can be a person but is generally either a commercial or academic organization contracted by the sponsor to perform a sponsor’s clinical trial related duties and functions. Typically, a CRO is used to design a protocol, monitor, evaluate reports, and prepare submissions to the FDA.

80
Q

What is the role of a CRO in the context of GCP?

A

The CRO is responsible for implementing quality assurance and quality control for the clinical trial. All GCP principles that apply to the sponsor also apply to the CRO.

81
Q

What are the regulatory requirements regarding transfer of obligations?

A

All regulations that apply to the sponsor also apply to the CRO. The CRO is subject to the same regulatory actions that can be taken against a sponsor for failure to comply with the regulations.

Specifically, 21 CFR Part 312.52 describes the transfer of obligations to a CRO. The transfer of each responsibility from a sponsor to a CRO should be put into writing. If all obligations for a clinical trial are transferred, a general statement that all obligations have been transferred is allowed. Any obligation that is not specified in writing remains with the sponsor.

82
Q

When should a sponsor use a CRO?

A

A sponsor should use a CRO for a number of reasons:

The sponsor may not be able to hire sufficient staff. All pharmaceutical companies face challenges hiring sufficient staff with the skills and experience required to conduct a clinical trial. Smaller pharmaceutical companies in particular do not have the resource capacity to conduct all clinical trial activities. A CRO may have a greater resource capacity (including staff, expertise, equipment, storage, and facilities) than the sponsor for managing the various aspects of the clinical trial.

A sponsor may not have the knowledge of the regulations that apply in a foreign country or region. It may make more sense to hire a CRO that is familiar the local regulations.

Outsourcing to a CRO gives the sponsor the ability to conduct multiple clinical trials at once while maintaining sufficient quality oversight.

From a cost perspective, a sponsor can convert the fixed and overhead costs of maintaining in-house personnel, expertise, and facilities into variable costs by outsourcing to a CRO.

83
Q

How should a CRO be selected?

A

From an operational perspective, a sponsor should look for a CRO with expertise in the therapeutic area being studied or in data management. A CRO may have better equipment, storage, and facilities than the sponsor for managing certain aspects of the clinical trial.
From a regulatory perspective, a sponsor should look for a CRO that has past experience with the respective division of FDA or with the local regulatory agency where the study will be conducted.

From a quality perspective, a sponsor should select a CRO that has standard operating procedures in place, staff that is properly trained, and an independent quality assurance unit. The CRO should also perform routine audits of its contractors and subcontractors.

From a business perspective, the longevity and reputation of the institution or the company is important. The sponsor should check references from past clients of the CRO who performed similar activities. The ability of the CRO to communicate well and work with its client’s specific culture is important. A detailed communication plan between the sponsor, the CRO, and clinical trial sites must consider time zones and clear roles and responsibilities. The CRO must be able to meet the timeline requirements for the study and have staff available.

From a cost perspective, the overall cost of hiring the CRO should be consistent with the anticipated quality and timeline for the activities that are being outsourced. Clear procedures for change orders should be established. Metrics can also be established for assessing the quality of the collaboration and return on investment in the relationship.

84
Q

What types of activities can a CRO perform?

A

A CRO can directly manage the clinical trial sites including contract and budget negotiations, making site payments, creating the study manual, tracking enrollment, maintaining the site files (especially the clinical trial master file), and managing site supplies.

A CRO often monitors clinical trial sites to assess safety and compliance with study blindness and randomization. A CRO may already have a central depot in place that can take packaged supplies and distribute them directly to the site as needed. A central laboratory function or bioanalytical laboratory may already be in place at a CRO.

A CRO designs case report forms, sets up databases, performs data management and statistical analyses, and writes clinical study reports.

A CRO can set up a clinical endpoint committee consisting of independent experts who review and evaluate endpoints as they are described in the protocol. Specific clinical trial requirements that a sponsor does not have in-house may be outsourced to a CRO with expertise in that area. A CRO also performs audits of vendors or subcontractors and clinical sites to ensure compliance with the protocol, GCP, and the applicable regulations.

85
Q

Describe the common regulations that drug studies and device studies follow.

A

The common regulations that drug and device studies follow include:

21 CFR part 50 (Protection of Human Subjects)
21 CFR part 56 (Institutional Review Boards)
21 CFR part 54 (Financial Disclosure)
21 CFR part 11 (Electronic Records)
HIPAA Privacy Rule

86
Q

How long is the process to bring drugs from inception to market release? How long is the device process?

A

The process for bringing drugs from inception to market release can take up to 15 years. By contrast, the process for devices is shorter, usually between 3 and 9 years. The reason for this is that new devices—with updated technology—are often introduced every few years.

87
Q

Do devices require dosing studies? Do device studies require pivotal studies?

A

Devices do not require dosing studies (in contrast to drugs). However, devices do require pivotal studies.

88
Q

Name some of the device categories used by the CDRH.

A

Device categories used by the CDRH include the following:

Clinical chemistry and clinical toxicology
Hematology and pathology
Immunology and microbiology
Anesthesiology
Cardiovascular
Dental
Ear, nose, and throat
Gastroenterology & urology
General and plastic surgery
General hospital and personal use
Neurological
Ophthalmic
Orthopedic and physical medicine
Obstetrical and gynecological
Radiology
89
Q

Class I Devices

A

For class I devices, these are low risk devices and only general controls are needed to market the device. This is a reasonable assurance of the safety and effectiveness. Some examples are surgical instruments, wound dressings, contact lenses, and a toothbrush. Based on their low risk status, class I devices do not need a pre-market notification to the FDA, but can be marketed with documentation of the classification and demonstration of good manufacturing practices and a robust risk determination.

90
Q

Class II Devices

A

A class II device, or moderate risk device, need general and special controls. For example, they need performance standards and surveillance documentation. Some examples include infusion pumps that are not unplanted, vascular clamps, sutures, electrocardiograms, or ECGs, and urology catheters. For class II devices, one must obtain a 510(k) clearance or de novo classification. The required documentation includes design, validation, and verification, all special controls and demonstration of equivalence to a pre-amendment device– also known as a predicate device.

91
Q

Class III Devices

A

Class III devices are moderate and high risk devices, so general and special controls alone are insufficient. Clinical data and pre-market approval are required. These are usually life supporting, life sustaining, or are important in preventing impairment or have a potential for unreasonable risk. Some of these examples are defibrillators, vascular grafts, angioplasty catheters, and drug eluding stents. The class III device requires a pre-market approval application, or PMA. This application requires the most extensive documentation that all controls are verified and validated and demonstration of safety and effectiveness are established both on benchtop and via clinical study.

92
Q

When is an IDE needed?

A

If you are studying a device that is not yet cleared or approved for marketing, and you want to test the device in humans, then an IDE is required—unless the device qualifies for an exemption.

93
Q

What devices are exempt from an IDE?

A

The following kinds of devices are exempt from an IDE:

Non-invasive diagnostic
Consumer preference testing
Solely for veterinary use
Used for research with lab animals
Custom device (not being used to determine safety and efficacy for commercial distribution)
94
Q

Implanted insulin pumps would need to follow what pathway to commercialization?

A

An implanted insulin pump would be considered a Class III (moderate/high risk) device and would therefore require a Premarket Approval Application (or PMA).

95
Q

Under what circumstances does the Humanitarian Device Exemption (HDE) allow access to devices?

A

An HDE allows access to Humanitarian Use Devices (HUDs) under the following circumstances:

An IRB approves the device.
The device is clearly labeled as a Humanitarian Use Device.
Effectiveness has not been demonstrated.
Safety is demonstrated (i.e., the device does not pose an unreasonable risk of illness or injury).
The probable benefit outweighs the risk.
The device will not serve more than 4000 patients per year.

96
Q

A sponsor has an implantable defibrillator that has an approved diagnostic capability. The sponsor wants to collect data from interrogations from follow-up visits to use in educational material for physicians. All patient identification is to be masked before submission to the sponsor. The study is not impacting the doctor’s normal clinical practice or changing how he performs his follow-up. Remember that this defibrillator is already on the market and no new procedures are being performed.

A

Because this implanted device is already market released, and because the study is not changing any procedures that are already being performed for the treatment of patients, this is a Non-Significant Risk (NSR) study.

97
Q

Form 1572 must be completed for all device studies.

True or False?

A

False. An investigator agreement is sufficient for device studies.

98
Q

To whom do you report an unanticipated adverse device effect?

A

You report an unanticipated adverse device effect to the FDA and the IRB.

99
Q

Why would finding an investigator be harder for a device study?

A

Reasons that finding an investigator for a study is more difficult for devices than drugs include the following:

Sometimes it is difficult to find enough doctors with the expertise to perform a procedure with a specialty device.
Some of the experts maintain private practices that do not have the capacity or resources to do clinical research—either in terms of equipment or people to collect data.
Some doctors may be experts in the specialty you are studying, but may have poor skills with your device.
Marketing colleagues may have specific doctors in mind who they think are “important,” and must be included in the study, but who are not qualified to do the clinical research.
Performing a device study in a university setting may also be difficult, because one must constantly train the new personnel—residents and fellows—in the use of the device.

PBHLTHX400.2-068 Introduction to Clinical Research: Clinical Trial Phases and Design (1 decks)

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