The following is a short piece of correspondence with Apothecaries Clinical Research, which is cited on the Dynamiclear page.
E-mail excerpt sent to Apothecaries Clinical Research:
|I have several major concerns about this study. The first is even conducting a phase III trial when there is no published evidence of any phase I or phase II work having ever been conducted. This would seem to be a pretty gross violation of India' GCP standards.
My second major concern is over the size of the study, since when is a hundred odd participants a phase III study?
And lastly, failure to use any blinding or controls on the study seems to be a major oversite that calls into question the works as a whole.
Is there anyone that can respond to my concerns? Is this essentially a marketing tool that Dynamiclear paid you for, or is this the standard that you use when conducting all your phase III trials. Do you think if I were to send this to a major drug regulatory service in the US or Europe they would say it was a successful phase III trial and approve the drug or would they have concerns as well?
Excerpt of reply from Apothecaries Clinical Research:
|1.The clinical trial was conducted as per a protocol that received approval from Indian regulatory authorities as well from concerned ethics committees and to the best of our knowledge and belief – there was no violation of any applicable law or GCP guidelines.
2.A Phase III (or any phase study) does not necessarily happen with a pre-ordained number of patients. The sample size is calculated based on the objectives of the study. This study was conducted as a proof-of-concept study and number of patients were accordingly determined by the Sponsor.
3.Many proof of concept studies are conducted without any comparators or controls. In several cases - no comparator products may be available. Scientific attitude is founded on inquisitiveness and questioning: that is the grain of science. The study being referred by you has been conducted as per the protocol and results have been objectively reported. It is for the reviewer of study report to decide if the protocol and data are sufficient and usable for the purpose for which user is reviewing the data. Likewise, it is for regulators to decide if they are satisfied with the study protocol (including study design and number of patients) before they decide to register a product. Likewise, it may not be considered necessary to conduct a Phase I and Phase II study for well known substances: you would not need a Phase I study to explore a new indication for Acetyl Salicylic Acid. Regulatory pharmacology does tend to be fuzzy at most times: else – we will not need regulators as software would suffice to apply straight-forward regulatory logics.
4.As an independent CRO providing services to various global blue-chip pharma companies based in US and Japan – we are retained to conduct clinical trials that comply with the protocol and all applicable regulations and guidelines. We’ve no stakes in outcomes of the studies. I can assure you that it was same for this clinical trial too.