RCTs within the database: a feasibility study of statin effectiveness

• Research type

  Research Study

• Full title

  RETRO-PRO: The effectiveness of simvastatin compared to atorvastatin: an e-clinical randomised trial within a research database in routine clinical practice - a feasibility study

• IRAS ID

  14274

• Contact name

  Tjeerd-Pieter van Staa

• Sponsor organisation

  London School of Hygiene & Tropical Medicine

• Eudract number

  2009-014913-28

• ISRCTN Number

  ISRCTN33113202

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Many patients use statins or lipid-lowering drugs for heart disease. Although there are laboratory data suggesting that some types of statins may be better than others, there is not much evidence for physicians to decide what type of statin to prefer. This proposal wants to evaluate whether it is possible for general practitioners to conduct a study that compares two popular types of statins. This study will use a simple and novel method for collecting information on what happens to patients over a long period of time after starting statin treatment. This information will be based on information that is already routinely collected in the NHS. As an example, when patients are admitted to a hospital, the disease causing the hospitalisation is recorded in order to help the administration of the NHS and the patient??s GP is informed about the hospitalisation. This kind of routinely collected information will be used in this proposal. Currently, most studies are conducted in specialist centres rather than in general practices. Also, information is routinely collected using paper report forms rather than using routinely collected health records. If this proposal is successful, more studies can be conducted in general practices (where most patients are seen). More evidence will be available to guide patients and physicians on how to treat diseases. All information in this study will be fully anomymised (the researchers will not know the patient??s name and contact details) and will be collected from the General Practice Research Database that is widely used for monitoring of side-effects and research in diseases. This is a feasibility study on a relatively small number of participants to assess whether the "simple study methodology" of recruitment in routine clinical care and of data collection using standard NHS records could be used to run studies in general practice.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/30

• Date of REC Opinion

  3 Feb 2011

• REC opinion

  Further Information Favourable Opinion