clinical trial start up activities lahar ppt 3.pptx

Clinical research

1. A .U. C O LLE G E O F P H AR M ACEU T I CAL SC I E NCE S VISAKHAPATNAM SEMINAR PRESENTATION on Mr.S.Lahar Reg.No : 623209530010 First semester M.Pharmacy (Pharmacy Practice) Pharmacology division. Subject: Clinical Research Clinical trail start up activities 1 Seminar 4

2. WHO Definition: AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 2 Prospectively assigned human participants to one or more health related interventions to evaluate the effects on health outcomes.

3. Clinical trial start up activity : It covers a lot of activities starting from sites Identification and completing the enrolment of the first patient. In between this includes site selection and pre- study visits, trial documents ,submission to competent authorities, contract and budget execution ,vendors approval and setup, site activation. Steps involved in clinical trial start up activities: Site feasibility studies Site / investigator selection Pre-study visit Investigator meeting Clinical trial agreement execution Ethics committee document preparation and submission AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 3

4. Steps involved in clinical trial start up activities Site feasibility studies: site feasibility is the process of evaluating the possibility of conducting a clinical trial or study at a particular site. The process aims at ensuring that the proposed clinical site can conduct The trial, with in the budget and the timeline, maintain data integrity and participant safety. Types of feasibility study: Technical feasibility : Process of validating the technical resources and capabilities to convert the ideas into work system. Economic feasibility : Involves a cost benefits analysis. To identify how well or how poorly, a project will be concluded. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 4

5. Conti…. 3. Legal feasibility : Performed to understand well a proposed system solves the problems . 4. Operation feasibility : performed to understand well a proposed System solves the problems. 5 . Scheduling feasibility : Measure of how reasonable the project duration. Benefits of a feasibility study: Save time money and resources. Enhance the team‘s focus. Helps in identification of new opportunities . Enhance the probability of success in a short span of time. Helps to make clear future growth plans. Helps make realistic assumption. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 5

6. Site /investigator selection: The sponsor is responsible for selecting the investigator / institutions taking into account the appropriateness and availability of the study site and facilities. The sponsor must assure it self of the investigators qualification. and availability for the entire duration of the study. Before entering on agreement with an investigators / institutions to conduct a study, the sponsor should provide the investigator / institutions with the protocol and up to date investigator brochure. Sponsor should provide sufficient time to review the protocol and the information provided in the investigator brochure. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 6

7. Pre – study visits(PSV): Depending on the company you work for and the standard operating procedures(SOPs), you m ay be required to complete an in person pre-study visit(PSV) before an investigator is initiated to join a clinical trial. In some cases, you May even be able to perform this via telephone, web–conference . Objectives of the PSV: Evaluate condition of site. Understand the full capabilities of the physical location and the abilities of the site staff. Review patient recruitment strategies. Meet principal investigator (PI) confirm or gain comfort regarding their ability and interest for the protocol. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 7

8. Cont... This is typically a 2-4 hour visit. After your visit, you will likely need to complete a report template or assessment and send a follow up latter to thank the site for hosting you and inform them whether or not they have bee chosen to participate in the study. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 8

9. Investigator meeting : In investigator meeting (IM ) all the potential investigators are brought together in a typically quite fancy hotel /other conference area to receive group training on the new study. This will actually take place on - site. This is usually a 4-8 hours visit and You May be accompanied by a project leader, medical monitor, or even data management personnel just depending on the desire of the sponsor. Before your visit, you will coordinate a convenient time for the study site and confirm your visit with a letter informing them when you will arrive and what the objectives of the visit will be. It is important to physically be at the site so, as a monitor, you can visit the labs, pharmacies, and other areas where the research will be conducted to ensure they are adequate. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 9

10. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 10 Clinical trial Agreement (CTA ) execution : The sponsor should enter into a formal and legal agreement /contract with the investigators/institutions on the following terms. To conduct the study in compliance with GCP, the applicable regulatory requirements and the protocol agreed to by the sponsor and given approval /favourable opinion. To comply with the procedures for data recording, and reporting. To permit monitoring, auditing and inspection. To retain the study related essential documents until the sponsor informs the investigators /institutions in writing that these documents are no longer needed. The agreement should define the relationship between the investigators and the sponsor in matter such as financial support, fees, honorarium payments in kind etc... AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP.

11. Executing the CTA: The CTA includes the sponsor and site, and may also include a CRO in which case the document will outline the same parameters for CRO involvement. because ultimate responsibility at the site rests on the principle investigator, usually the PI must sign the CTA. Sponsors leverage template CTAs that they use with every site they may have different templates for different kinds of institutions. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 11

12. Ethics committe : The sponsor /investigator should seek the opinion of an Institutional ethics committee regarding suitability of the protocol , methods and documents to be used in recruitment of subject and obtaining their informed consent including adequacy of the information being provided to the subjects. The ethics committee are entrusted not only with the initial view of the proposed research protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring for the compliance of the ethics of the approved programmes till the some are completed . AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 12

13. Ethics committee document preparation : All documentation and communication of an Institutional E thics C ommittee (IEC) are to be dated, filed and preserved according to written procedures, strict confidentiality is to be maintained during access and retrieval procedures. Records should be maintained for the following: The constitution and composition of the IEC . Standing operating procedures of the IEC . Copies of the protocol, data collection, CRFs, Investigational brochures ( IB) etc . Submitted for review. All correspondence with IEC members and investigators regarding application, decision and follow up. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 13

14. Ethics committee document preparation : Conti… 7.Agenda of all IEC meetings. 8. Minutes of all IEC meetings with signature of the chairperson. 9.Copies of decisions communicated to the applicants. 10 . Record of all notification issued for premature termination if a study with a summary of the reasons. 11. Final report of the study including CDs and video recording . It is recommended that all records must be safely maintained after the completion termination of the study for at least a period of 5 years . AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 14

15. Ethics committee document submission: The research should submit an appropriate application to the IEC in a prescribed format along with the study protocol at least three weeks in advance . The protocol should include the following : Clear research objectives and rationale for undertaking the investigation in human subjects in the light of existing knowledge . Subject recruitment procedures. Inclusion and exclusion criteria for entry of subjects in the study. Precise description of methodology of the proposed research, including intended dosages and routes of administration of drugs, planned duration of treatment and details of invasive procedures if any. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 15

16. Cont... 6. A description of plans to withdraw or withhold standard therapies in the course of research. 7. The plans for statistical analysis of the study . 8. Procedure for seeking and obtaining informed consent forms in English and vernacular languages. 9. Safety if proposed intervention and any drug or vaccine to be tested, including results of relevant laboratory and animal research. 10. For research carrying more that minimal risk ,an account of plans to provide medical therapy for such risk or injury or toxicity due to over-dosage should be included . AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 16

17. Cont... 12. Storage and maintenance of all data collected during the trial. 13. Plans for publication of results – positive/ negative –while maintaining the privacy and confidentiality of the study participants . 15. All other relevant documents related to study protocol including regulatory clearances. 16. Agreement to comply with national and international GCP protocols for clinical trials. 17. Details of funding agency/sponsor and fund allocation for the proposed work. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 17

18. References' Good clinical practice for clinical research in I ndia. Schedule Y (Amended version- 2005) GCP – CDSCO ( central drug standard control organization.) Turner N. The key to successful study start up :Right path , Right start patients. Iqvia .2020. Jack kaufman . the innovative start ups improving clinical trial recruitment , enrolment , retention and design , November 30,2018. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 18

19. AU.COLLEGE OF PHARMACEUTICAL SCIENCES, VSKP. 19 Thank you…