FEATURE into the scientific community faster . Of course , that ’ s partly because there is no formal peer review built into preprint .”
Faster dissemination allows for more real-time feedback , she added , and preprint also may foster collaborations – for instance , a researcher may see a paper in preprint , realize that her group is working on something similar , and reach out to the authors of that preprint paper .
At bioRxiv . org , authors retain copyright , according to a blog post at ASAPBio from John R . Inglis , PhD , executive director of Cold Spring Harbor Laboratory ( CSHL ) in New York , which operates the preprint server . By posting on bioRxiv . org , authors explicitly consent to text mining of their work ( e . g ., by search engines or researchers ). Once an article is published in a journal , bioRxiv . org will automatically update the preprint with a link to the published version . 9
Preprint also “ provides a way of transparently showing progress that could , in principle , be used to demonstrate productivity to anyone evaluating a researcher , whether that ’ s his or her funding source , his or her institution , or other stakeholders ,” Dr . Polka said .
Ideally , a preprint article undergoes screening , and preprint research must meet at least two basic criteria , she explained . First , it cannot be copied or plagiarized work , and , second , it must be within the scope of the server ’ s designated scientific field .
Plagiarism is a potential issue with preprint , although not necessarily a widespread one . According to an analysis of the arXiv . org preprint server , there were some signs of , at best , text overlap , and at worst , scientific plagiarism , according to an article in Science . The article goes on to state “ it appears that copying text from other papers is more common in some nations than others , but the outcome is generally the same for authors who copy extensively : Their papers don ’ t get cited much .” 10
And in a review article on preprint servers , Nicholas G . Tomaiuolo , instruction librarian , and Joan G . Packer , head of reference , at the Elihu Burritt Library at Central Connecticut State University in New Britain , Connecticut , acknowledged that plagiarism is a risk associated with all electronic publishing , but that the additional feedback from interested parties in the pre-print system was likely to compensate for this risk . Also , they suggested that “ authors evidently see [ plagiarism ] as more of a potential problem than an actual one .” 11
“ The checks are designed to ensure that the work is ethically disclosed ,” Dr . Polka added . “ That work is usually done by a combination of computer algorithms , followed by a human
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screener who will review the paper to ensure it fits within the server ’ s scope . This screening is very light ; there ’ s no intention of questioning the importance or the validity of the work .”
In that respect , preprint does not “ challenge the critical role of the journals , which is to validate the work ,” Dr . Polka stressed . In her estimation , preprint and all journals can work together and , indeed journals such as Nature and Science accept preprint because of the latter ’ s successful track record in the
PROVEN PROPHYLAXIS moments
DOSING SCHEDULE =
THEIR WAY
n + SIMPLE ,* TWICE-WEEKLY
ADYNOVATE prophylaxis helped patients achieve
+ 95 % reduction in median overall ABR vs on-demand treatment † 1 + Zero median ABR for joint or spontaneous bleeding episodes ‡ 1
* ADYNOVATE allows patients to infuse on the same 2 days every week . 1
†
1.9 ( Q1 : 0.0 ; Q3 : 5.9 ) vs on-demand 41.5 ( Q1 : 31.7 ; Q3 : 51.1 ); 4.7 ( SD 8.6 ) mean vs on-demand 40.8 ( SD 16.3 ). 1 , 2
‡
Joint : 0.0 ( Q1 : 0.0 ; Q3 : 2.0 ) median vs on-demand 38.1 ( Q1 : 24.5 ; Q3 : 44.6 ); 2.9 ( SD 8.0 ) mean vs on-demand 34.7 ( SD 15.1 ). Spontaneous : 0.0 ( Q1 : 0.0 ; Q3 : 2.2 ) median vs on-demand 21.6 ( Q1 : 11.2 ; Q3 : 33.2 ); 2.9 ( SD 7.1 ) mean vs on-demand 26.0 ( SD 19.6 ). 1 , 2
The safety , efficacy , and PK of ADYNOVATE were evaluated in a multicenter , open-label , prospective , nonrandomized , 2-arm clinical study ( N = 137 ) that compared the efficacy of a twice-weekly prophylactic treatment regimen to on-demand treatment and determined hemostatic efficacy in the treatment of bleeding episodes . 1
For patients 12 years and older with hemophilia A
ADYNOVATE [ Antihemophilic Factor ( Recombinant ), PEGylated ] Important Information
Indication
ADYNOVATE , Antihemophilic Factor ( Recombinant ), PEGylated , is a human antihemophilic factor indicated in adolescent and adult patients ( 12 years and older ) with hemophilia A ( congenital factor VIII deficiency ) for :
• On-demand treatment and control of bleeding episodes
• Routine prophylaxis to reduce the frequency of bleeding episodes
ADYNOVATE is not indicated for the treatment of von Willebrand disease .
DETAILED IMPORTANT RISK INFORMATION CONTRAINDICATIONS
ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE , to the parent molecule ( ADVATE [ Antihemophilic Factor ( Recombinant )]), mouse or hamster protein , or excipients of ADYNOVATE ( e . g . Tris , mannitol , trehalose , glutathione , and / or polysorbate 80 ).
WARNINGS & PRECAUTIONS Hypersensitivity Reactions
Hypersensitivity reactions are possible with ADYNOVATE . Allergic-type hypersensitivity reactions , including anaphylaxis ,
BAXALTA , ADVATE and ADYNOVATE are trademarks or registered trademarks of Baxalta Incorporated , a wholly owned , indirect subsidiary of Shire plc . SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates . USBS / MG159 / 16-0047
physical sciences world , she said .
“ One of ASAPBio ’ s goals is to have conversations with journals about preprint ,” Dr . Polka explained . “ We view preprint as analogous to a conference presentation . It ’ s a different way to communicate within the scientific community .”
Curt Rice , PhD , rector ( president ) of Oslo and Akershus University College of Applied Sciences in Norway , agreed that while preprints may lead to a new type of peer review , the latter is still important to
For more information , visit www . ADYNOVATEPRO . com
ABR = annualized bleeding rate .
have been reported with other recombinant antihemophilic factor VIII products , including the parent molecule , ADVATE . Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema , chest tightness , dyspnea , wheezing , urticaria , and pruritus . Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur .
Neutralizing Antibodies
Formation of neutralizing antibodies ( inhibitors ) to factor VIII can occur following administration of ADYNOVATE . Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests . Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected , or if bleeding is not controlled with expected dose .
ADVERSE REACTIONS
Common adverse reactions ( ≥1 % of subjects ) reported in the clinical studies were headache and nausea .
Please see the following page for the Brief Summary of ADYNOVATE .
References : 1 . ADYNOVATE Prescribing Information . Westlake Village , CA : Baxalta US Inc . 2 . Data on file . Baxalta Incorporated .