Algernon Pharmaceuticals Inc (AGNPF)

[tcm7]

NIH guidelines appear to want a full report at "completion" and then publication. CRIS implied confidentiality until publishing data thru International Committee of Medical Journal Editors. ?...GLTA... Discussing a "signal" is unclear to me. I guess AGN will have inside info as Trials proceed but making "claims" needs documented verification.?.

Lots of info and different procedures depending on ***.

https://www.ncbi.nlm.nih.gov/books/NBK286004/

Benefit patients and future research participants. An essential step in science is verification and replication of investigators' claims. Once investigators have published their findings, as responsible scientists they should allow other researchers to subject those findings to scrutiny. Allowing timely verification and reproduction serves the public good by preventing other researchers or clinicians from building on findings whose validity cannot be established and by preventing patients from receiving recommendations for clinical care that are based on invalid information. Moreover, sharing clinical trial data benefits patients by allowing other investigators to carry out additional analyses that provide valid scientific information about the effectiveness and safety of the study intervention. In addition, sharing clinical trial data prevents participants in future research from being placed at unwarranted risk because the benefits of an intervention are smaller or the risks greater than claimed in a publication. Furthermore, sharing clinical trial data may increase public trust in the scientific and clinical trials ecosystem.
Protect the professional interests of clinical trialists in gaining fair professional rewards for their intellectual effort and time by giving them reasonable time to analyze and publish data from a trial they have planned and carried out. In the long run, this protection of the interests of trialists will benefit the public and future patients by creating incentives for investigators to carry out clinical trials; conversely, failure to allow clinical trialists time to publish their findings will discourage investigators from proposing and conducting trials.
Protect the commercial interests of the sponsors in gaining regulatory approval for a product or indication they have developed and tested, so that they can gain fair financial rewards for their investment of financial and intellectual capital. If a sponsor shares extensive data before a product gains regulatory approval, follow-on developers may gain commercial and strategic advantages. In addition, as a matter of fairness, other companies should not use shared clinical trial data as the predominant basis for their own regulatory submissions—for example, seeking approval for a generic version of the product in a country that does not recognize data exclusivity. In the long run, such incentives to sponsors will benefit the public and future patients by incentivizing investors and companies to develop new medical products and bring basic science discoveries to patients; failure to do so will discourage investments in health care innovation and product development that would ultimately benefit future patients.
Allow other researchers to access the data in order to reproduce the results of a published trial, synthesize results across trials, and carry out additional or exploratory analyses. Such secondary uses of the data will increase the benefits to society and future patients in terms of knowledge gained from the clinical trial and the contributions of the trial participants.
Policies regarding responsible sharing of specific clinical trial data at particular times in the life cycle of a clinical trial need to balance these countervailing goals and interests. To strike a reasonable balance, the committee proposes releasing specific types of clinical trial data “packages” at different timepoints in the life of a clinical trial