Last Updated on March 6, 2024
Division of Pharmacy Services, DRAP, under Rule 20 of the Bio-Study Rules 2017 maintains a clinical trial registry for approved clinical trials involving human subjects being conducted in Pakistan.
Drug Regulatory Authority of Pakistan has recently adapted U.S. National Trial Registry as an international registry for all clinical trial approved by the Clinical Studies Committee, DRAP.
- Principal Investigators / Responsible parties (Sponsors) nominate a focal person from their organizations, to open & maintain PRS (Protocol Registration & Results System) account.
- All Principal Investigators / Responsible parties (Sponsors) will enlist their approved Clinical Trials on U.S. National Trial Registry and after getting “NCT” identifier number will inform to Division of Pharmacy Services-DRAP.
- NCT Number: The National Clinical Trial number is an identification that ClinicalTrials.gov assigns a study when it is registered. The NCT number is in the format “NCTXXXXXXXX”. Until an NCT number is assigned, the study is not registered on the U.S. National Trial registry.
Clinical Trials Subject Registry
A verifiable record of the clinical trial participants or subjects be maintained to stop duplicate enrolment and also to improve both patient safety and preserve data integrity of clinical trials. The subject identification shall be a closed information from the investigator, directly submitted to the DRAP.
Rejected Applications of Clinical Trials
The Drug Regulatory Authority of Pakistan (DRAP) has a stringent process for approving clinical trials. Applications may be rejected due to non-compliance with the rules, regulations, and procedures implemented by DRAP under the Bio-Study Rules, 2017. The detail of applications for clinical trials rejected by the Clinical Studies Committee are as under: –
| Sr. No. | Date | CSC No. | Title of Study/ Trial | Clinical Research activity Status | Remarks Reference (if any) |
|---|---|---|---|---|---|
| 1 | 20/1/2020 | CSC-06 | Pioneer Research Solutions (Pvt) Ltd., Islamabad For CRO. (Application to act as Contract Research Organization-CRO) | Contract Research Organization-CRO | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements, decided to reject the application. |
| 2 | 2/5/2020 | CSC-11 | Study title: "To determine the bioequivalence of test product Clarithro® 500mg Tablets manufactured by M/s Nabiqasim Industries (Pvt) Ltd, Karachi in health adult human subjects, compared with reference product Klaricid® 500mg Tablets, Manufactured by M/s Abbot Laboratories, Karachi." | Bioequivalence Study | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and upon request of PI, decided to reject the application. |
| 3 | 2/5/2020 | CSC-11 | Study title: "A Single Center, Open Label, Randomized, Single Dose, Two way Cross-over Study to explore the Relative Bioavailability of Moksi (Moxifloxacin) 400mg Tablet of M/s Abbott Laboratories and Avelox (Moxifloxacin) 400mg Tablet of M/s Bayer Pharmaceuticals under the fasting conditions in Healthy Male Pakistani Subjects. | Bioavailability Study | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements, decided to reject the application. |
| 4 | 2/5/2020 | CSC-11 | A comparative, open labelled, multicentre, parallel arm, controlled, and randomized study with 2 parallel groups to compare the efficacy and safety of test drug (Megafer Injection) with reference (Venofer Injection) in outpatient woman with Iron deficiency anaemia (IDA). | Clinical Trial | Applicant in reference to this division reminder letter number F.No.14-11/2018 DD (PS) dated 20th April 2020 submitted withdrawal letter from subject application, Hence CSC decided to reject the case for further processing. |
| 5 | 2/5/2020 | CSC-11 | An open labelled, controlled, and randomized study with 2 parallel groups to compare the efficacy and safety of test drug (Rexyl cough syrup) with reference (Hydryllin cough syrup) in adult outpatients with productive cough. | Clinical Trial | Applicant in reference to this division reminder letter number F.No.14-11/2018 DD (PS) dated 20th April 2020 submitted withdrawal letter from subject application, Hence CSC decided to reject the case for further processing. |
| 6 | 2/5/2020 | CSC-11 | Open Label, Non-Randomized, Multi-Center investigator initiated study to evaluate effectiveness of generic Velpatasvir and Sofosbuvir in Hepatitis-C with or without Ribavirin among Pakistani population. | Clinical Trial | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements, decided to reject the application. |
| 7 | 12/2/2021 | CSC-19 | Convalescent plasma treatment in covid-19 patients: non-randomised open label clinical trial at a tertiary care center in Pakistan. | Clinical Trial | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements like even fee submission, decided to reject the application. |
| 7 | 13/10/2022 | CSC-35 | Clinical Trial Titled Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of Covid-19. | Clinical Trial | The CSC after detailed discussion and deliberations decided to reject the case due to noncompliance |
| 13/10/2022 | CSC-35 | “Open label, two cohorts (with & without Imiglucerase), multicenter study to evaluate pharmacokinetics, safety & efficacy of eliglustat in pediatric patient with gaucher disease type 1 and type 3 (Elikids).” | Clinical Trial | The applicant asked for termination of the subject trial/study initiation process in Pakistan on 10th June, 2022, due to non-compliance to codal requirements, CSC decided to reject the application. | |
| 8 | 13/10/2022 | CSC-35 | Approval of Rehman Medical Center, Peshawar To act as Clinical Trial Site for Phase-II Clinical Trials. | Clinical Trial Site | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements, decided to reject the application. |
| 9 | 21/11/2022 | CSC-36 | Clinical Trial Site (CTS) For Phase-II (Trial Specific) From M/s Abdul Waheed Trust (Aviceena Dental College), Lahore | Clinical Trial Site | The CSC discussed the application in detail in light of recommendation of inspection panel report. It was decided to reject the case. |