2019-11-15

[#DIV28SUPER] Info Requested Re NIH Clinical Trials

 

Colleagues, Jeremy Wolfe and FABBS are looking to identify researchers who are willing to share their experience preregistering and reporting experimental results in NIH's proposed clinical trials framework. See below – share with your colleagues who may be able to provide insights to help develop a more reasonable policy.

 

Patricia Clem Kobor | Sr. Science Policy Analyst

Government Relations | (202) 336-5933| pkobor@apa.org

American Psychological Association: www.apaservices.org

Twitter: @APA, @APAScience

Advancing psychology to benefit society and improve people's lives

 

 

 

Dear All (on my informal NIH Clinical Trials email list) 

Hope life is treating you well. I am hoping you have some ideas for us. "Us" is FABBS (Federation of Associations of Behavioral and Brain Sciences). We are still working to mitigate the not-so-good effects of the NIH's Clinical Trials policy. As you probably know, at the moment, the rules for registering and reporting studies are in abeyance for a couple of years while the NIH tries to develop a sane system of registration. SO…here is where you come in. The US National Library of Medicine (NLM) is looking researchers to help them develop registration systems that work.  

We are looking for people who preregistered their studies and have now published these. You don't have to have preregistered in CT.gov. I, for example, have been using the Open Science Framework. 

FABBS has been asked to identify 10 such investigators who are doing work that might be problematic to register in ClinicalTrials.gov. NLM is particularly interested in NIH-funded basic experimental studies involving humans ("BESH") work that has any of these four characteristics.

 

1.           Does the study/project/paper consist of multiple experiments (Exps 1-N in your paper), not just one big "clinical trial".

 

2.           Does the analysis use an outcome measure that was not pre-specified. For example, maybe Reviewer 2 asked for an item analysis or maybe for a new control experiment. That wasin't in the original pre-registration.

 

3.           Does meaningful reporting of the data require recording non-aggregated results (like individual observer data).

 

4.           Does the project includes preliminary experiments that serve largely to optimize procedures.

 

So……do you have some ideas about researchers who we could approach?

Self-nomination is fine….encouraged….They/you would need to give us a bit of time and a bit of documentation. Who can you think of?

 

Many thanks!

 

         Jeremy Wolfe

         And Juliane Baron (FABBS Exec Director)

 

 

Jeremy M Wolfe, PhD 
Professor of Ophthalmology & Radiology, 
Harvard Medical School

Visual Attention Lab   
Department of Surgery   
Brigham & Women's Hospital

65 Landsdowne St
4th Floor
Cambridge, MA  02139 

Phone:  617-768-8818
Fax:  617-768-8816

Best email: jwolfe@bwh.harvard.edu
Backup: jeremywolfe0131@gmail.com
URL: search.bwh.harvard.edu

Editor: Cognitive Research: Principles and Implications (CRPI)
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http://www.cognitiveresearchjournal.springeropen.com/

 

 

 

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