Pain (Post Herpetic Neuralgia)
Small Molecule Repurposing 505(b)(2) Proof of Concept Clinical Trial requiring enrolment of
350+ patients in under 6 months.
A New York based mid-size pharma company wanted a quick PoC clinical trial to get the Yes-No answer for a novel indication (topical use for PHN) for an oral drug that was approved for completely different indications. They had only 12 months to complete the entire project, including submissions, site initiations, enrolments of 360 patients, SDV and database lock and desired a fail-proof plan to meet that timeline. The study involved
Apothecaries was responsible for managing the entire clinical trial project, right from protocol development to database lock and transfer.
Apothecaries converted their study-synopsis into a complete study-protocol, made submissions, obtained regulatory as well as EC clearances (including controlled substance related permissions), enrolled 360 patients in under 5 months and locked the database in about 11 months. The challenging narrow inclusion criteria and the enrolment target was achieved by initiating 35 sites within 2 weeks. Each site was managed through an SMO function to ensure timely patient enrolments, patient retention, compliance and data quality. The project was intensively managed to ensure that complete database was transferred to the client to perform data analysis and prepare the CSR.
Antibiotic for a Resistant Chest Infection
1 Year Treatment Period Clinical Trial
The study had been initiated 2 years ago and was far behind its enrolment targets. Investors were pushing for remaining enrolments to be completed in not more than 18 months. The protocol required several esoteric tests to be conducted for which the patients' specimens had to be moved to some study dedicated, highly sophisticated laboratory complying with BSL-3 standards and such labs are very rare across the world. Patient retention was expected to be another big challenge because the patients (largely expected to be impoverished) were expected to be asymptomatic in about 3 months but had to continue taking the drug for another 6 months, followed by 9 months follow-up period.
The Clinical Operations Head of this Wall Street headquartered organization, who had experienced Apothecaries' services while working for one of the World's top 3 pharma companies, approached us with the protocol synopsis and discussed all the underlying challenges. Apothecaries was offered a letter of intent which mentioned that about $10m study would be contracted provided (i) Apothecaries would invest about $2m to set up the study dedicated BSL-3 lab, meeting the CDC-Atlanta specifications, within 6 months (ii) The lab is approved by Sponsor's auditors (UCL, London) and (iii) Apothecaries could establish systems and processes to be deployed for accruing and retaining patients (which was the basic challenge being faced by the Sponsor).
Apothecaries organized resources (including investments) and established the lab within 6 months. The lab was audited and approved by 3 different US and UK based bodies. The study was contracted to Apothecaries to complete the recruitments within 8 months. A Project Management team initiated 70 sites and each site was intensively managed by the SMO function by deploying site-dedicated CRCs. A study-dedicated logistics team managed to ship the investigational products from our 10000 sq. feet central pharmacy, under cold-chain conditions, and to retrieve patients' specimens from sites. The dedicated lab functioned 24x7 to test the specimens because preliminary reports were used to determine inclusion eligibility of the patients. Patient enrolment targets (including global deficits) were met in less than 7 months. The astonished Sponsor got the laboratory and site operations monitored almost on monthly basis, without any major or critical findings. An army of social workers ensured that only 2% patients dropped out of the study over 1 year treatment and 6 months follow-up period.