It's important that physicians and patients have timely access to clinical trial outcomes to help guide the best treatment options. If data is not shared and made publicly available, then the scientific record might be distorted — since there has been a historical tendency to publish positive results more than negative results — and efforts of trial sponsors and participants could be wasted if an unpublished failed trial is unknowingly repeated.
Disclosure rates are improving
Both the FDA and the EMA require summary data to be published within 12 months of trial completion (although there are exceptions, for example to protect commercially sensitive information). Are sponsors meeting these requirements? The numbers depend on what data and analysis you look at, but the key message is that disclosure rates are improving.
ClinicalTrials.gov is the most common forum for disclosing results. A recent analysis by STAT of trials in this database that should have disclosed outcomes found that 72% of them had posted results. This compares with 58% in similar analysis two years ago. A website, developed by the University of Oxford, which gives almost real time reporting of disclosure compliance from ClinicalTrials.gov shows that 65% of required trials have disclosed data (accessed May 17, 2018).
Our product, TrialFinder, can quickly assist you to find which trials in ClinicalTrials.gov have results available. The TrialFinder dashboard contains interactive filters, allowing you to quickly drill down to trials with results, saving you the tedium and time of manually searching on a one-by-one basis.
Did you know that as well as aiding patients and doctors, better access to clinical trial results can boost competitive intelligence for sponsors? Read our blog post on this topic.
Another recent publication that used ClinicalTrials.gov as well as additional databases — the European Clinical Trials Database, sponsor company trial registries and the WHO International Clinical Trials Registry Platform — showed that disclosure rate within 12 months of trial completion was an impressive 93%. This analysis included only approved medicines, so could be biased towards positive results, but nevertheless showed that disclosure compliance had increased by about 20% compared to an earlier analysis.
What should and could be shared?
On ClinicalTrials.gov, summary level data should include:
- Participant flow - Numbers of participants who started, completed and dropped out
- Baseline characteristics - Patient demographics and study-specific measurements
- Outcome measures - Primary, secondary and post-hoc outcomes
- Statistical analyses
- Adverse events
The EMA mandates that more detailed information, in the form of clinical study reports (CSRs), is published following a marketing authorization application. The FDA introduced a pilot program of publishing CSRs this year in order to "evaluate whether disclosing certain information included within CSRs following approval of a new drug application improves public access to drug approval information", said FDA Commissioner Scott Gottlieb in a statement.
Some sponsors are going one step further, and releasing patient-level data (but through controlled access mechanisms), which opens up opportunities for further research such as comparative effectiveness studies, clinical trial modelling and additional analysis by third parties.
A helping hand with data transparency
There are a number of initiatives that help sponsors and other stakeholders meet the requirements of data disclosure. For example, the TransCelerate Clinical Data Transparency Initiative provides guidance and model approaches for redacting privacy information found in CSRs, anonymizing patient-level data and preparing and distributing layperson summaries.
The ICMJE (International Committee of Medical Journal Editors) state that trials published in their journals must contain a data sharing statement and/or data sharing plan, and several other medical journals are part of the AllTrials initiative, which advocates timely trial results disclosure. Medical research funders and NGOs have signed up to a World Health Organization policy that is working toward a timeframe of 12 months after study completion as the global norm for summary results disclosure.
There's is still a way to go until all trials have published results in a timely manner, but with policies and tools in place to encourage sponsors, it hopefully won't be long before patients, physicians and other interested parties are able to find the results that they need.
Industry teams use BrackenData Analytics to analyze data on their competitors' clinical trials. Signup to get a personal demonstration of how to use BrackenData Analytics for competitive intelligence: