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Imaging Clinical Trials.
Imaging clinical trialists face complexities not shared by other clinicians conducting clinical experiments. Although much has been written on the subject of Clinical Trials, this Wiki serves as a resource for those imaging professionals who need more than mere familiarity with the design and conduct of clinical trials. Its content arose from key modules of the mentoring program conducted jointly by RSNA and NCI for select young imaging faculty who plan careers as professional clinical trialists.

Consult the User's Guide for information on using the wiki software.----

Concepts and FAQ's addressed in this course

How does a screening trial differ from a therapeutic trial?

How does a randomized control trial (RCT) differ from an observational trial?

Must the control arm of a therapeutic RCT always be a placebo?

What distinguishes Phase 1, 2, 3 and 4 trials?

What are ‘Phase 0’ trials and what role would imaging have in them?

What data do you need to determine a statistically valid study size?

When does a trial need a Data Safety Monitoring (DSM) board?

What functions do interim and futility analyses serve?

What are the definitions of type 1 and type 2 errors?

How do you constitute an imaging central reading review panel and how does it function?

What is the regulatory definition (e.g. FDA) of a “surrogate’ biomarker?

How do “prognostic” biomarkers differ from ‘predictive’ markers?

What happens if an ‘adverse event’ occurs to a study subject?

Abbreviations and Definitions

CR (Complete Response)

DFS (Disease Free Survival)

ORR (Objective Response Rate)in solid tumors represents measurable reduction in the dimension of target tumor masses when depicted on imaging

OS (Overall Survival)

PD (Progressive Disease)

PR (Partial Response)

PFS (Progression Free Survival)

RR (Response Rate) represents data that implies an attenuation of the amount of tumor burden realtive to the degree present at baseline and can include either reduced symptoms or shrinkage of measured tumor size.

RECIST Response Evaluation Criteria for Imaging in Solid Tumors

SD (Stable Disease)

TTP (Time to Progression)

Target Lesions tumors visible at baseline that are measured sequentially over time by the RECIST criteria http://www.eortc.org/Recist/Default.htm

Useful Wiki outLinks

1. List of Cancers. http://www.cancer.gov/cancertopics/alphalist
2. PDQ. http://www.cancer.gov/cancertopics/pdq  peer-reviewed summaries of cancer treatment, screening, genetics and a clinical trials directory
3. Learning about Clinical Trials. http://www.cancer.gov/clinicaltrials/learning
4. Search for Clinical Trials. http://www.cancer.gov/search/clinicaltrials
5. Conducting Clinical Trials http://www.cancer.gov/clinicaltrials/conducting
6. NCI Cancer Therapy Evaluation Program (CTEP) http://ctep.cancer.gov
7. NCI Cancer Imaging Program http://imaging.cancer.gov
8. RECIST criteria http://www.eortc.org/Recist/Default.htm
9. RECIST original article http://www.eortc.org/Services/Doc/RECIST.pdf

Software that's essential for your efficiency

You can't be efficient until you have a thorough knowledge of the following software applications. Spend some time learning them intimately - it will be worth it.

• Acrobat Professional – especially when you need to extract text (Select Tool) and images (Advanced  ->export all images); track changes (Comments & Markup); or publish a smaller, unchangeable PPT as a PDF;
• Word – convert to Adobe PDF using an Acrobat plug-in; Track changes (ctrl+shift+E); email document as a draft for comment; add images; has hierarchical outline view
• Endnote – links to Word; does its’ own PUBmed searching, constructs a complete bibliography and dynamically formats your references while you write
• PowerPoint (PPT) – you can incorporate and edit web pages and images for presentations. And it's an easy way to construct protocol flow schemas
• Quosa – http://www.quosa.com/  connects automatically to PubMed and extracts full article PDFs if you are allowed to do so by your institutional license.

Informed Consent and Ethics

Informed consent is an essential part of the ethical conduct of clinical trials. For more detailed discussion follow this link > Informed Consent

Investigational Drugs and Devices

Investigational means any drug or device not currently marketed in the US in the exact form that you are using for the exact indication for which you are using it.  For example, updated device software is investigational, as is investigation of an marketed drug for a disease or histology that is not explicitly in the drug labeling. For more detailed discussion follow this link > Investigational Drugs & Devices

Imaging as a Measure of Therapeutic Response

Suppose you were asked to devise an imaging acquisition protocol and analysis scheme for a new drug therapeutic trial that might be submitted to FDA. Can you come up with a list of the key considerations you might want to go through?

• If you'd like a Socratic list of 20 questions you ought to consider, try this link > Instructive use-case problems for clinical trial imagers