Basing Informed Decisions on the Totality of the Evidence
In a March 2012 editorial for Circulation: Cardiovascular Quality and Outcomes, Harlan Krumholz, Director of the YODA project, identified the steps required to achieve the fullest use of clinical research data to benefit patient care:
- Post, in the public domain, the study protocol for each published trial. The protocol should be comprehensive and include policies and procedures relevant to actions taken in the trial.
- Develop mechanisms for those who own trial data to share their raw data and individual patient data.
- Encourage industry to commit to place all its clinical research data relevant to approved products in the public domain. This action would acknowledge that the privilege of selling products is accompanied by a responsibility to share all the clinical research data relevant to the products’ benefits and harms.
- Develop a culture within academics that values data sharing and open science. After a period in which the original investigators can complete their funded studies, the data should be de-identified and made available for investigators globally.
- Identify, within all systematic reviews, trials that are not published, using sources such as clinicaltrials.gov and regulatory postings to determine what is missing.
- Share data.
Krumholz, H.M. 2012. Open Science and Data Sharing in Clinical Research: Basing Informed Decisions on the Totality of the Evidence. Circ Cardiovasc Qual Outcomes. 5:141-142.
Other recent relevant articles include:
Ross, J.S., Lehman, R. and C.P. Gross. 2012. The Importance of Clinical Trial Data Sharing: Toward More Open Science. Circ Cardiovasc Qual Outcomes. 5:238-240.
Spertus, J.A. 2012. The Double-Edged Sword of Open Access to Research Data. Circ Cardiovasc Qual Outcomes. 5:143-144.
Gotzsche, P.C. 2012. Strengthening and Opening Up Health Research by Sharing Our Raw Data. Circ Cardiovasc Qual Outcomes. 5:236-237.