Singapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY

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1 Singapore Clinical Trials Register Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY

2 Clinical Trial Register Global Trend EMA: EU Clinical Trials Register FDA AA expands registry & adds results reporting requirements WHO International CT Registry: create a global network ICMJE: Publication only if trial registered at its outset ClinicalTrials.gov launched in Feb 2000 FDA MA mandates registry - IND trials for serious & life-threatening diseases

3 Clinical Trial Register Factors influencing Disclosure REGULATORY ICMJE IRBs COMPANY / ORGANISATIONAL POLICIES

4 Clinical Trial Register Target Audience - Stakeholders PI and clinical research team Clinical researchers in same field Clinical researchers in other fields Academia Readers of the medical literature Lay public 4 4

5 Clinical Trial Register - Benefits Increasing transparency and accountability Helps solve the problems associated with publication bias Assist researchers conducting meta-analyses of trial results to create systematic reviews of the literature on treatments for a particular disease (regardless of whether the results were positive, negative, or inconclusive) Researchers Industry Reveal areas of fruitful future investigations and identify better opportunities for research

6 Clinical Trial Register - Benefits Helps physicians identify treatments under study and for future research Keeps track of new advanced therapies, its goals and outcomes for different conditions to better advise patients Generate new ideas for investigations or look for data trends by accessing all the trials conducted on a drug or therapy Patients Healthcare Professionals Providing just-in-time information about the particular condition or intervention under study Helps patients find trials that they could find it eligible for participation Individuals suffering from various diseases, and their family members, want to know that appropriate therapies are being offered Ability to search on their own for research that pertains to their disease and potentially to enroll in a clinical trial if suitable, enhancing recruitment

7 Benchmark Survey to Identify End User Needs for the Registration and Disclosure of CT Information Health Canada Sept 2005

8 Clinical Trial Register IT platform HSA PRISM online system for clinical trial application Relevant application information extracted for population in CT register Accuracy of CT registry information will be checked during screening/evaluation of application CT register will also accommodate amendments to clinical trial information (e.g., change of principal investigator, addition of trial site) Launch for public access on HSA Website : 1 Sep 2012

9 Key Data Set in CT Register (PRISM) Protocol Title/ No. Phase Therapeutic Area Intervention [Name of Study Drug] Sponsor Trial Site Principal Investigator Status [ongoing or completed]

10 Clinical Trial Register Future Plans Clinical Trials Register data-set Register data extracted from current Clinical Trial Application e-form, which at present is limited to information currently captured in e-form Moving forward New IT system revamp planned Information on all 20 fields planned in revised Clinical Trial Application e-form Will meet all 20 fields in WHO minimal data set

11 Clinical Trial Register Future Plans Zarin DA, Tse T.. Science Mar 7;319(5868): Future plan: Voluntary results posting on Singapore CT Register 11 11

12 Clinical Trial Register Future Plans Additional Enhancements to consider: Posting of clinical trial results (voluntary) Link to regional and global trial information & status Individual trial link to clinicaltrials.gov. mobile applications? Consultation with stakeholders on enhancements

13 Clinical Trial Register - Impact Public Trust Shaping medical decision making Patient Access Shaping medical decision making Protecting and Promoting Public Health Shaping medical decision making Public- Private Research Collaboration Shaping medical decision making Clinical Research Efficiency

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23 Conclusion (1) Initiatives in clinical trials registration have made information more accessible to all stakeholders and enhancing public confidence & trust Registration is only part of the means to an end; that end is full transparency with respect to performance and reporting of clinical trials Promotes evidence-based medicine leading to better health outcome

24 Conclusion (2) HSA first priority is to ensure the safety and wellbeing of subjects participating clinical trials HSA will continuingly review and strengthen the regulatory framework and at the same time also facilitating the process One key aspect is stakeholders information and empowerment. The launch of the CT Register marks a step forward to have an informed public

25 Knowing is not enough; we must apply. Willing is not enough; we must do. - Goethe