Observational studies form an important part of research as they provide an important contribution to our clinical evidence base and real-world data (RWD). In fact, they provide the most reliable source of data for long-term outcomes and safety of clinical interventions, they support prescribing decisions/patient management and are of increasing relevance in research where this data is used to provide supplementary information to inform future research planning (1-3). Furthermore, there is an increasing need for additional insights on epidemiology, compliance, adherence and costs in a realistic environment, which cannot be obtained through randomised controlled trials but by using a number of RWD sources.

Observational studies differ from interventional studies such as clinical trials in that there are no interventions prospectively assigned to participants by a protocol and they are subject to fewer regulatory controls. Given this, observational studies generally have a lower risk profile than clinical trials and subsequently fewer governance controls in place compared to the current standards placed on clinical trial studies. Observational studies are however not without risk such as data sharing plans, privacy considerations and contractual obligations. Much of this can be de-risked through careful consideration at the protocol development and planning stages.

Emphasis is often placed on institutions having robust research governance frameworks for clinical trials. However, research governance of observational studies should not be left behind. A Research Governance Framework that fosters and promotes good research practices for all research (not just clinical trials) will ensure all studies conducted under an institution’s auspices conform with applicable laws, meet the highest ethical and scientific quality standards, and ensure the lowest possible risk to the institution, researchers and participants. Given the growth in global collaborations and routine data sharing across borders, there has never been a more important time to ensure governance frameworks are in place.

References:

  1. https://ebmh.bmj.com/content/23/2/83

  2. https://pubmed.ncbi.nlm.nih.gov/18036390/

  3. https://academic.oup.com/rheumatology/article/57/Supplement_7/vii54/5115896

  4. https://www.safetyandquality.gov.au/standards/clinical-trials