The Site Council consists of clinical research sites and site networks dedicated to the professional conduct of clinical research studies and the advancement of the clinical research enterprise. We have created the Site Council Bill of Rights to clarify site priorities for sponsors and CROs. Sites must earn these rights by conducting clinical studies in a safe, ethical, efficient, high-quality and timely manner. We believe that the clinical research enterprise can succeed only when study sponsors and CROs have healthy relationships with healthy sites. It may not be sustainable otherwise.
The Site Council Bill of Rights includes six fundamental rights (supported by 24 practical examples):
- The Right to Essential Information
- The Right to Professional Autonomy
- The Right to Fair and Timely Compensation
- The Right to Proficient Governance
- The Right to Patient Centricity
- The Right to a Collaborative Relationship
The clinical research enterprise has been wrestling with the same problems between sites and sponsors/CROs for over 40 years. We have discussed these problems and possible solutions in numerous forums, but we have never actually solved any of them on a systemic basis. The Site Council is creating a virtuous cycle to fix these problems systemically.
The Site Council is growing fast, with over 1,200 members, including 28 site networks and 30 AMCs and health systems. To view the Executive Committee, click here. To read a press release, click here. To download a flyer, click here.
We invite clinical research sites and site networks to join the Site Council. There are no membership dues. The only member time commitment -- which is modest -- is talking about the Site Council Bill of Rights with study sponsors and CROs when they bring you a new study. When study sponsors and CROs consistently hear from important sites about the Site Council Bill of Rights, they will have to take it seriously. To join the Site Council, click here.
We are getting traction with study sponsors and CROs, who can join as Supporters. We are also working with organizations that have trusted relationships with numerous sites, who can join as Partners. There are no membership dues.
The clinical research enterprise has been wrestling with the same problems for over 40 years. Let's try a new, more strategic and collaborative approach to solving them. The patients can't wait.
The Broader Context
The deceptively named Inflation Reduction Act of 2022 includes one section that, while misguided and perhaps even counterproductive, may reduce inflation: the prescription drug provisions. These provisions direct Medicare to "negotiate" drug prices with pharmaceutical companies. The Supreme Court will probably have something to say about the coercive overreach of these provisions, but the larger issue is that there is bipartisan support for government intervention in drug pricing. The harsh reality is that the high cost of many essential drugs is simply not sustainable. We can talk about the high value of high-priced drugs, but Medicare’s pockets – and the pockets of our health system, in general – are just not deep enough to cover their costs when widely prescribed.
We need to look at this problem another way, and that’s where clinical research comes in. The consensus opinion of senior clinical operations executives is that over half – yes, half -- of the cost and time in a typical clinical trial is wasted. Some say 80%. Do the math on your own studies: Compare the cost of the test article, procedures, tests, and assessments that generate data to the total cost of the study – it will probably be a tiny fraction. Do sites really need study coordinators spending one day a week on redundant data entry? Do sites really need armies of CTA negotiators renegotiating the same terms over and over again? Legions of accounts-receivable clerks chasing late and poorly documented payments from study sponsors and CROs?
The Site Council is addressing fundamental problems that needlessly inflate costs, timelines and risks in the clinical research enterprise. Let’s stop bailing and start fixing the boat.