Ethical and transparent design, delivery and reporting of clinical trials is crucial to patient-centred healthcare.
Open publication and transparent results
The ethical design and delivery, open publication and transparent result reporting of clinical trials and research is vital in improving the quality of healthcare to patients. Without full access to the results of clinical trials, healthcare professionals and regulators cannot make informed recommendations on treatment options and patients are unable to make informed decisions on their healthcare.
The publication of clinical trial results is critical to ensuring that patients have accurate information on treatments, their efficacy and their relative benefits versus risk.
IAPO supports the development and enforcement of appropriate regulations on all aspects of clinical trials and research. The key issues from the patients’ perspective are:
- Protection of the rights and welfare of patients
- Ensuring that patients have access to quality information regarding clinical trials
- Meaningful informed consent, with specific strategies regarding vulnerable patient groups
- Meaningful patient involvement across all aspects of clinical trials and throughout the process
- Transparency about all outcomes and results of trials, whether successful or not
We have responded to several initiatives and consultations on clinical trials and research. These include:
- Responding to a World Medical Association (WMA) consultation on the Declaration of Helsinki. The Declaration of Helsinki is a set of ethical principles regarding the use of human subjects in medical research
- Responding to a European Medicines Agency (EMA) consultation on clinical trials
- Responding to WHO on their Statement on Public Disclosure of Clinical Trial Results
- Following approval at its May 2013 Governing Board Meeting, IAPO endorsed the AllTrials campaign as an important step towards greater transparency and patient information