Replies to post #234236 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Correction: Hearsay, not heresy. Although I kind of think I spellcheck stumbled onto a more descriptive synonym..

[exwannabe]

She repeated the efficacy analysis claim in San Fran on 1/12/15

Senti's transcript:

So, first off… the DCVax-L Phase three program, we will continue expanding that program. You can look for announcements during this Q1 in that regard. We will be sometime this year conducting the first interim analysis for efficacy. That will be conducted by the Data Monitoring Committee. Up to now, the assessments have only been safety, so this will be the first assessment for efficacy.

And if she was privately telling some there would be no IA, and publicly saying there would be an IA, that is a reg FD violation.

[Evaluate]

you wrote:

Now Dr. Bosch and the rest of NWBO are emphasizing not conducting an efficacy data lock until the SAP is etched in stone.

1) I do not recall "the rest of NWBO" emphasizing that an efficacy data lock will not be conducted until SAP is etched in stone.

2) I thought that Dr Bosch was indicating that the SAP had to be etched in stone prior to "hard lock" & topline.
Which might not preclude that a "soft lock" has already taken place?
I have the impression that one needs to do a soft lock, and then conduct an audit of the data (including completion of all the queries).
I also have the impression that once NWBO has "finalized" the SAPs (after submitting the draft SAPs and after some back and forth with RAs to make sure that they are on board with the concept of the revised SAP), then the final data lock would be expected shortly thereafter. And then the data analysis, based on the final SAPs, will start to take place soon too.
I think there will typically be a reasonable amount of time between soft lock and hard lock .... so I imagine that the soft lock would take place perhaps a minimum of 6 months prior to completion of the draft & final SAP?
www.ijrpc.com/files/25-10-16/28-6122.pdf includes:

The success of any clinical trial is dependent on assuring that the data collected is of good quality. Clinical Data Management is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. It is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Audit forms an important part of a quality system to assure the data generated is of high-quality, reliable, and statistically sound and to provide verification of data integrity. Clinical data base audits may be conducted at any facility or institution where clinical trials are conducted on human volunteers or subjects. Auditors should be selected based on the suitable qualifications, experience and training. Adherence to specific audit principles is a prerequisite for providing a reliable and relevant audit outcome. Like in all other audits, database audits require careful preparation. Audits of the database are conducted between ‘soft lock’ and ‘hard lock’ (’freeze’ and ‘lock’) of the database. Data transcribed from a Case Report Form or other source into the database is usually checked for accuracy through a database audit.

data base audit program will point out potential problem areas early, so solutions can be found before the data submission to regulatory authorities.

audit = a systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor‘s standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirement(s).