A great deal of progress has been made to increase data transparency for clinical trials. The sponsors who have rapidly increased transparency deserve our gratitude. They’re the reason why, now more than ever, more progress is possible through commitments to action on data transparency by all sponsor organizations.
Data transparency gives authorized researchers access to the clinical trial data on which the regulatory decisions for new medicines are based. In late 2013, I wrote about “Five Steps to Success” with clinical trial data transparency. These five steps were:
- Decide to participate.
- Make the data decisions.
- Implement a governance process.
- Deploy a secure analytics repository.
- Inform the research community and the public.
Considerable progress in a very short time
In a very short timeframe, many biopharmaceutical companies have elected to make clinical trial data and supporting documents available to researchers through various approaches, such as:
- Clinicalstudydatarequest.com, which currently provides study information for eight clinical trial sponsors.
- University-affiliated “independent review committees.” At least one company is using The Yale School of Medicine’s Open Data Access Project (YODA) to gather and review researcher requests. In addition, Duke Clinical Research Institute (CDRI) is providing an independent review committee to review researcher data access requests for a biopharmaceutical company.
- Consortiums such as Project Data Sphere – an initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium.
- Pharma company websites. Some organizations are providing the ability to request clinical data access from their own company website.
While the list of organizations that have committed to greater transparency grows with each passing month, some sponsors of clinical trials have not taken action.
Some companies are waiting
Although a great deal of progress has been made in a very short time by the early pioneers of clinical trial data transparency, some biopharmaceutical organizations are waiting to take action toward providing researchers with access to anonymized patient-level data from their clinical trials. Why take a wait-and-see approach? Perhaps these organizations are waiting for a regulatory mandate. Or maybe they hope the stakeholders requesting greater transparency will be satisfied by the current progress.
The bottom line is that the stakeholders demanding greater transparency into clinical trial results expect full participation and not partial transparency.
Commitment requires action
Delaying the decision to participate isn’t a sound strategy, and here’s why:
- High participation rates from all sponsors can help to prevent further scrutiny from regulatory authorities and other stakeholders.
- Regulatory mandates may be more onerous if the entire industry is not showing progress by taking immediate action to implement data transparency.
- The stakeholders are resolute. You can expect the advocates for greater transparency to be extremely dedicated – even tenacious – in pursuing access to clinical study data.
Increased access to clinical trial data for authorized researchers can be a valuable resource for the discovery of new medical knowledge. The new insights will have the potential to improve public health for decades to come. Greater transparency also helps to increase public trust in the industry. Commitment and action from all sponsors of clinical research will help to make data transparency a reality.
To learn more about how SAS can help, visit our clinical data transparency page on sas.com.