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Saturday, February 06, 2021 2:54:46 PM
To further bolster your artillery of info I'd ask that you take this into consideration as you move forward with your good deeds:
1) Oncologists and other members of the cancer care team would presumably want that information sooner rather than later to be able to more appropriately prescribe those drugs and take care of their patients. But new data that reviewed 100 pharmaceutical company-sponsored clinical trials shows that the median delay from when results are available to publication of complete data was 300 days, with negative findings taking longer to reach the public. The study was recently published online in JAMA Oncology (2018; doi:10.1001/jamaoncol.2018.0264).
“The complete and timely dissemination of clinical trial data is essential to all fields of medicine, with delayed or incomplete data release having potentially deleterious effects on both patient care and scientific inquiry,” the researchers noted in the study. “Even for the most pressing study findings, median publication delays approach 1 year.”
https://journals.lww.com/oncology-times/fulltext/2018/09200/3_questions_on____how_long_it_takes_to_publish.16.aspx#:~:text=But%20new%20data%20that%20reviewed,longer%20to%20reach%20the%20public.
2) From https://www.ncbi.nlm.nih.gov/books/NBK285993/
Taken together, these are compelling justifications for sharing clinical trial data to benefit society and future patients. The challenge is to set clear expectations that clinical trial data should be shared and to agree on how to do so in a responsible manner that mitigates the risks involved. Stakeholders have concerns about data sharing. Clinical trial participants want assurance that data will be shared in a way that protects privacy and is consistent with informed consent. Sponsors want a quiet period for regulators to evaluate the entire body of evidence submitted to them, appropriate safeguards for intellectual property and commercially confidential information, and protections from invalid secondary analyses. Academic clinical trialists want time to analyze and publish the data they have collected and thereby gain appropriate professional recognition for planning, organizing, and running clinical trials whose data are subsequently used by other investigators. Research institutions fear that requirements for sharing clinical trial data will be unfunded mandates. Participant and patient advocates want clinical trial data to be widely available in order to advance the development of new treatments. If data sharing is to be broadly accepted and fulfill its promise, these concerns of key stakeholders will need to be acknowledged and addressed. Moreover, the sharing of clinical trial data needs to be carried out in a way that maintains incentives for sponsors and researchers to develop new therapies and carry out future clinical trials and that sustains participants' willingness to participate in trials.
There are many nuggets in here that you might find informative as you expose future PUMPS/SCAMS
3) As I have shared before, I think you will find this useful to update your underlying agenda: https://www.ncbi.nlm.nih.gov/books/NBK286004/
4) Lastly, I know you brought into question the size of the DCVaxL trial. Spread the word on the stats included below as continue forward with your good deeds.
https://academic.oup.com/neuro-oncology/article/20/8/1034/4922286
Forty-five trials were terminated early. Reason for termination was available on ClinicalTrials.gov for 38 (84%) terminated studies. Recorded as reasons for termination were lack of accrual (19 trials), lack of funding (6 trials), futility (6 trials), drug availability (3 trials), administrative reasons pertaining to protocol (eg, principal investigator left the institution in 5 trials), and safety (1 trial). Median trial duration for terminated studies (all phases) was 31 months (range 11 to 50 mo) for ND and 31 months (range 14 to 71 mo) for recurrent trials.
Based on the number of patients accrued to trials between 2008 and 2012 and the incidence of GBM over the same time period, we estimated that approximately 8%–11% of newly diagnosed GBM patients enrolled on therapeutic clinical trials. In 2010 there were approximately 2035 total enrollments on clinical trials, representing an estimated 10.2% of the annual prevalence (19972 GBM cases) in the US.8 As stated above, this analysis does not account for individual patients enrolling on more than one trial.
The clinical trials landscape for GBM is characterized by long development times, inadequate dissemination of information, suboptimal go/no-go decision making, and low patient participation. Truly amazing this PUMP/SCAM made it to PH III for an RCT..the odds were definitely again them!!
Please feel free to share this info with those in your team and again, myself and I'm sure many here would like to thank you for all your charitable time, energy and passion!!
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