The clinical research enterprise can succeed only when study sponsors and CROs have healthy relationships with healthy sites – that is our Dream. It may not be sustainable otherwise.
The Site Council is an industry collaboration that speaks with a common voice to eradicate serious problems that sites have had with sponsors and CROs for over 40 years. By sapping time, money and energy, these problems interfere with effective study conduct. We have discussed these problems and possible solutions in countless forums, but we have systemically solved only one of them: redundant GCP training for principal investigators.
The Site Council is growing fast, with thousands of members, including 38 site networks and 51 AMCs and health systems. To view the Executive Committee, click here.
The Site Council Dream clarifies site priorities for sponsors and CROs. Member sites gently encourage sponsors and CROs to support the Site Council Dream. No membership fees, no paperwork, just some communication. To benefit from the Dream, sites must conduct clinical studies in a safe, ethical, efficient, high-quality and timely manner.
Sponsors and CROs support the Site Council Dream by working constructively to implement it over time. No membership fees, no paperwork, no demands, no deadlines, just gentle encouragement. The magic happens when sponsors and CROs realize that their support is to their benefit because (a) the Site Council Dream is their checklist for becoming a study sponsor or CRO of choice and (b) resolving these problems will free up site resources to conduct their clinical research studies better.
The Site Council Dream lists 24 serious problems in six areas:
- Essential Information
- Professional Autonomy
- Fair and Timely Compensation
- Proficient Governance
- Patient Centricity
- A Collaborative Relationship
To view the Site Council Dream, click here. To download a flyer, click here. To join the Site Council, click here.
It doesn't have to be this way. Talk therapy isn't working. Let's try a new, collaborative approach to solving these problems. The patients can’t wait.
Resources
To view member resources. click here.
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, perhaps only one percent of total study costs. Do sites really need study coordinators spending one day a week on redundant data entry? 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.