Brainstorm Study

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Giorgio Aguilar

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Aug 3, 2024, 2:37:16 PM8/3/24

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In this context, a multidisciplinary Brain Metastases Clinical Research Platform named the BrainStorm program was launched in 2020 by the Institut Jules Bordet, within the Oncodistinct network (ClinicalTrials.gov ID NCT04109131). The BrainStorm program is an international, multicenter, prospective interventional study that is focused on individuals with newly diagnosed non-CNS metastatic solid tumors with a high risk of developing CNS metastases. This program is building a large clinico-pathological database of around 600 patients to investigate the development and epidemiology of CNS metastases, focusing on three time periods: before the diagnosis; at diagnosis; and after the diagnosis of CNS metastases (Table 1).

D.M.B. received honoraria from Daiichi Sankyo, Novartis, Merck Sharp & Dohme, Janssen, Pfizer, Angelini and AstraZeneca; meeting or travel grants from Novartis, Merck Sharp & Dohme, LEO Farmacuticos, Ipsen, Janssen, Roche, Laboratrios Vitria and Gilead Sciences; and institutional grants from Novartis and F. Hoffmann-La Roche Ltd (outside the submitted work); G.N.M. received travel grants for meetings from Roche and Bayer (outside the submitted work); A. Gombos has served on the advisory board for AstraZeneca, Daiichi Sankyo and Seattle Genetics; received travel grants from Pfizer and Astra Zeneca; and educational fees from Eli Lilly; E.B. received honoraria from Eisai, Merck Sharp & Dohme, Sandoz and Amgen; meeting or travel grants and non-financial support from Daiichi Sankyo, Eisai, Amgen, Sandoz, Merck Sharp & Dohme, Bristol-Myers Squibb, Novartis, Pfizer and Roche; and has consulted for Egle Tx; F.C. received honoraria or travel grants from Astra Zeneca, BMS, Merck, MSD, Lilly, Roche, Novartis, Pfizer and Gilead (outside the submitted work); S.H. received honoraria from Brystol Myers Squibb, and travel grants from Roche; C.C. received travel grants for meetings from Lilly Oncology and Pfizer; and honoraria from Lilly Oncology (outside the submitted work); F.P.D. received a postdoctoral research grant from Fondation Belge Contre le Cancer; consulting fees from Amgen, Astrazeneca, Daiichi Sankyo, Eli Lilly, Gilead Sciences, MSD, Novartis, Pfizer, Pierre Fabre, Roche and Seagen; and travel support from Amgen, Daiichi Sankyo/AstraZeneca, Gilead Sciences, Pfizer, Roche and Teva (outside the submitted work); L.D. received consulting fees to UZ Brussel from MSD, BMS, Astra Zeneca, Roche and Servier; and travel support from MSD and Roche; H.D. received consulting fees (advisory role) paid to their institution by Pfizer, Roche, PharmaMar, AstraZeneca, Eli Lilly, Novartis, Amgen, GSK, MSD, Seagen, Gilead; and other fees paid to their institution (travel, accommodations, expenses) by Pfizer, Roche, PharmaMar, Teva, AstraZeneca, MSD, GSK and Gilead (all outside the submitted work); P.M.C. reports study budget funds from AstraZeneca; and was an advisory board member for AbbVie, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi-Sankyo, Leo Pharma, Merck Serono, MSD, Rakuten and Vifor Pharma; J.G. received honoraria from Astra Zeneca, Daiichi, Eisai, Exact Science, Eva Pharm, Lilly, Menarini, Merck Sharp & Dohme, Novartis, Onxeo, Pfizer, Roche Genentech, Seattle Genetics and Sothema; meeting or travel grants from Astra Zeneca, Daiichi, Eisai, Eva Pharm, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche Genentech, Seattle Genetics and Sothema; and research support from Eisai, Exact Science and Roche Genentech; A.A. had an advisory role for Amgen, AstraZeneca, Bayer, Daiichi, EISAI, Genomic Health, Hengrui, Innate, Ipsen, Leo Pharma, Lilly, Merck, MSD, Novartis, Pfizer, Seattle Genetics, Viatris and Menarini; speaker fees from Amgen, AstraZeneca, Bayer, Daiichi, EISAI, Genomic Health, Ipsen, Leo Pharma, Lilly, Merck, MSD, Novartis, Pfizer and Seattle Genetics; and received research grants to their institution from BMS and Roche; N. Kotecki received meeting or travel grants from Ose Immunotherapeutics (outside the submitted work). P.B., A. Goncalves, E.D.E., V.V., C.D., F.L., J.L.C., M.P. and N. Kindt have no conflicts of interest to declare.

The team brainstorming session is a common way for drumming up new ideas but research suggests that they have one big problem: Group interactions, like brainstorming, can actually inhibit idea generation.

Few evidence-based studies have investigated effective brainstorming, so Paulus and colleagues designed two small exploratory experiments to put brainwriting to the test in a real office setting. Participants were employees at a global technology company that was looking for ways to improve productivity after hiring more staff.

In the first study, 57 employees were asked to come up with ideas about how to make an excellent, significant, and effective team. In one condition (alone-to-group), participants wrote down ideas on slips of paper individually first, followed by a group brainwriting session. After 10 minutes of writing ideas down individually, participants were asked to start passing their slips of paper around to the group as they continued to come up with ideas. In the other condition (group-to-alone), this order was reversed.

In a second study, Paulus and colleagues tested out a technique called asynchronous brainwriting, in which individuals quickly alternate between sharing with a group and working alone. The researchers hypothesized that this technique would allow for the best of both worlds, ultimately leading to more ideas than a straightforward group sharing session.

The asynchronous condition yielded more ideas than did the group condition. An analysis of the rate of ideas generated per person per minute during the idea generation sessions showed that the rate of idea generation was significantly higher in asynchronous condition (a 71% advantage).

Interesting research. However, it seems only to have reviewed the quantity of ideas generated rather than the quality of those ideas. Assuming the final aim of brainstorming, brainwriting, etc is to provide a creative solution to a problem, then a fewer number of higher quality ideas should be preferable to a smaller number (or even just one) high quality ideas.

We have found similar results in a subsequent study and in a second one we found that groups are good at building on previously generated ideas to develop high quality ones. Thus, generating a lot of ideas is fine since one can then build on the more novel ones to develop potentially useful and feasible versions.

Constance Dierickx discusses her work as an advisor to boards and senior executives in high-stakes leadership situations and her experiences helping psychologists learn how to be consultants.

Elizabeth Tenney, an associate professor of management at The University of Utah, discusses her research into overconfidence and biases that influence our social interactions and decisions.

Some of us come to that meeting with a bunch of brainstormed ideas. Others come with the seat-of-their-pants, more gifted at reacting and filtering than at brainstorming and planning on their own. Which is fine. We need all kinds of brains to pull a trick like this out of a hat.

One-week standalone session team-taught by one Progressive and one Traditionalist, for amicable balance. Instead of focusing on the plethora of lies, name-calling, and profanity that has erupted during this election cycle, focus on the ideas the presidential candidates have that track with Christian teachings.

NEW YORK, Nov. 17, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today topline results from the Company's randomized, double-blind placebo-controlled Phase 3 trial evaluating NurOwn (MSC-NTF cells) as a treatment for Amyotrophic lateral sclerosis (ALS). Results from the trial showed that NurOwn was generally well tolerated in this population of rapidly progressing ALS patients. While showing a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints, the trial did not reach statistically significant results.

The Phase 3 clinical trial's primary efficacy endpoint, a responder analysis evaluating the proportion of participants who experienced a 1.25 points per month improvement in the post-treatment Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope, was powered on assumed treatment response rates of 35% on NurOwn versus 15% on Placebo. These estimates were based on available historical clinical trial data and the NurOwn Phase 2 data. The primary endpoint was achieved in 34.7% of NurOwn participants versus 27.7% for Placebo (p=0.453). Therefore, the trial met the expected 35% NurOwn treatment group efficacy response assumption, however the high placebo response exceeded placebo responses observed in contemporary ALS trials. The secondary efficacy endpoint measuring average change in ALSFRS-R total score from baseline to Week 28, was -5.52 with NurOwn versus -5.88 on Placebo, a difference of 0.36 (p= 0.693).

In an important, pre-specified subgroup with early disease based on ALSFRS-R baseline score 35, NurOwn demonstrated a clinically meaningful treatment response across the primary and key secondary endpoints and remained consistent with our pre-trial, data-derived assumptions. In this subgroup, there were 34.6% responders who met the primary endpoint definition on NurOwn and 15.6% on Placebo (p=0.288), and the average change from baseline to week 28 in ALSFRS-R total score was -1.77 on NurOwn and -3.78 on Placebo (p=0.198), an improvement of 2.01 ALSFRS-R points favoring NurOwn.