Clinical trials from CRA s point of view
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1 Clinical trials from CRA s point of view Dr Jacek S Gregorczyk MPharmS, PhD Clinical Research Associate (CRA) at MDS Pharma Services UK office - a global CRO
2 REGULATION of CLINICAL TRIALS World Medical Association Declaration of Helsinki (est. 1964, last updated 2004) ICH-GCP guidelines EU directive 2001/20/EC EU directive 2003/94/EC EU directive 2005/28/EC Country specific regulations
3 REGULATION of CLINICAL TRIALS World Medical Association Declaration of Helsinki In medical research on human subjects, consideration to the well-being of the human subject should take precedence over the interests of science and society. It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject. The subjects must be volunteers and informed participation in the research project.
4 REGULATION of CLINICAL TRIALS ICH-GCP guidelines A unified standard for EU, Japan and US Covers all area of clinical trials Allows the Sponsor to delegate number of tasks to CRO Introduces monitor (CTM/CRA) role in the trials
5 REGULATION of CLINICAL TRIALS EU directive 2001/20/EC Introducing the law, regulations and administrative provisions of the Member States relating to the implementation on good clinical practice in the conduct of clinical trials on medicinal products for human use. Adopted by all 25 EU countries on 1 st of May Standardisation of processes and timelines in all EU countries.
6 REGULATION of CLINICAL TRIALS EU directive 2003/94/EC Introducing the the principles and guidelines of good manufacturing practices in respect of medicinal products for human use and investigational medicinal products for human use. Instruction for whole process of manufacturing and distribution of all medicinal products. Annex 13 describes GMP guidelines for IMP
7 REGULATION of CLINICAL TRIALS EU directive 2005/28/EC Introducing the the principles and detailed guidelines for good clinical practice as regards investigational medicine products for human use, as well the requirements for authorisation of the manufacturing or importation of such products. Extension of EU directive 2001/20/EC over import authorisation, archiving and inspection procedures.
8 REGULATION of CLINICAL TRIALS Country specific regulations Each EU country has own specific regulation UK: EC and RA submission in parallel Germany: EC and RA submission in parallel Poland: RA submission is done after EC submission
9 CLINICAL TRIALS in STEPS idea protocol feasibility PSV Site selection EC/RA SIV IMP realise recruitment MV(s) Data collection Database entry Database lock Statistical analysis Final report? CRA CTM
10 CLINICAL TRIALS in STEPS idea new medical substance new formulation new indication additional data request by RA protocol study objective study design study procedure and assessments
11 CLINICAL TRIALS in STEPS feasibility can we do the trails? patient population protocol feedback further suggestion
12 CLINICAL TRIALS in STEPS PSV PRE-STUDY VISIT study/protocol review investigator discussion site-specific issue document collection
13 CLINICAL TRIALS in STEPS Site selection site eligibility assessment based on PSV EC/RA EC (Ethics Committee) and RA (Regulatory Authority) approval is legal requirements essential part of critical documents requires for drug realise
14 CLINICAL TRIALS in STEPS SIV SITE INITIATION VISIT meeting team members explanation of study design/protocol requirements background of study medication how to record data (medical notes, CRF) investigator site file pharmacy file study supplies/procedures
15 CLINICAL TRIALS in STEPS IMP realise recruitment as soon as critical document pack is approved IMP (Investigational Medicine product) can be realised Pharmacy confirms IMP shipment patient recruitment is open
16 CLINICAL TRIALS in STEPS MV(s) SITE MONITORING VISIT to ensure that patient was properly consented to monitor patient safety to ensure that study is being conducted with ICH-GCP, the protocol and any other EC/RA requirements to ensure that data collected on CRF (Case Report Form) are complete and verifiable to perform IMP accountability
17 CLINICAL TRIALS in STEPS MV(s) INFORMED CONSENT A process by which a subject voluntary confirms his/her willingness to participate in a particular trials, after having been informed of all the aspects of the trails that are relevant to the subject s decision to participate. Informed consent is documented by means of a written, signed and dated inform consent form, both by a patient and a physician.
18 CLINICAL TRIALS in STEPS MV(s) PATIENT SAFETY Patient safety is priority # 1 in the clinical trials! Adverse Event(s) Pregnancy Precautions IMP handling, dispensing and administration
19 AE (adverse event) What is an AE? Any untoward medical occurrence in patient or a trail subject, administered a pharmaceutical product, which does not necessarily have to have a casual relationship with this treatment. New/worsened symptoms Abnormal medical exam Laboratory abnormalities A E Any pregnancy Accidents Drug dependency/abuse Under-/over- dose of IMP
20 What is a SAE? SAE - serious adverse event Seriousness criteria Results in death Is life-threatening A E Requires/prolongs hospitalisation Birth/congenital abnormalities Persistent disability/incapacity Other medical condition SAE
21 When AE is SAE/AR/SAR/SSAR/SUSAR? A E Serious? YES! Related to IMP? YES! AR Serious? YES! SSAR SAE Related to IMP? YES! SAR First SAR? NO! YES! SUSAR
22 PREGNANCY PRECAUSION Pregnancy precaution are mandatory! F M contraception during the whole study pregnancy tests during whole study (females) Pregnancy F M Study discontinuatio n Pregnancy report Follow up until Any abnormalities SAE Delivery
23 IMP HANDLING Is IMP storage acceptable? Has IMP expired? Has correct IMP been given to patient? Has correct dose been given to patient? What is patient compliance? Have all steps been properly recorded?
24 CLINICAL TRIALS in STEPS Data collection Database entry Database lock Statistical analysis Final report? site close out visit next phase drug licensing
25 ONCOLOGY TRIALS 1 placeb o cytostati c No phase one Special precautions with IMP handling No placebo group - always comparator
26 CONCLUSIONS Each step in clinical trials is well-defined Patient safety is priority #1 Monitor role is essential part of trials CRA is involved in many steps of trials CRA is the middle link between a Sponsor and patients Oncology trials have different design
27 QUESTIONS?
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