Innovation Pharmaceuticals Inc (IPIX)

[F1ash]

If a patient enrolls in a trial and then half way through he decides to drop out.

Can the company replace him or must his half treatment be included in the trial and be a part of the final statistics,...?

If he can be replaced I wonder why Leo did not replace the 7 or so patients that were defineded as not having followed the Protocol.

If they cannot be replaced couldn't industrial spys offer incentives to trial participants to drop out halfway,... in the case of competitive drugs,...?

Any info would would be appreciated!

Typically dropouts cannot just be replaced because it would bias the trial results. Most trials have some number of dropouts. There are different methods to deal with the missing data.


"Background: Pragmatically, intention to treat (ITT) analysis has become the ‘gold standard’ for analysing the results of clinical trials. Despite its popularity and wide use, ITT is not without its critics,controversies and misunderstandings. To perform an ideal ITT requires a full set of data, where all patients providing data are followed, independent of any protocol deviation. However, most of the time, clinicians and researchers are faced with non-compliance and drop-outs. Thus, researchers should be familiar with t'he concepts associated with ITT and strategies to deal with missing data

Intention to treat analysis, compliance, drop-outs and how to deal with missing data in clinical research: A review (PDF Download Available). Available from: https://www.researchgate.net/publication/233519659_Intention_to_treat_analysis_compliance_drop-outs_and_how_to_deal_with_missing_data_in_clinical_research_A_review [accessed Jul 18, 2017].



As long as the trial is sufficiently sized and as long as companies are careful to specify exactly what their data represents. {Label data with PP or ITT and what method was used to input missing results} it should not be that big of a problem. IPIX has done an excellent job of presenting accurate data with complete explanations of how missing data was handled and makes it perfectly clear if data is ITT or PP. Amazingly some other companies pretend like dropouts dont even exist in their graphs and don't even tell investors if it's ITT or PP data in their graphs. SMH... How they get away with that is inexplicable to me but they do.

Say what you want, but IPIX management plans and executes trials a hell of alot better than several other companies I follow. Many other companies use Investor Relations as a forcefield to prevent answering shareholder concerns, glad that doesn't happen here.