Conducting clinical research on a drug before it goes to market is expensive and time-consuming. However, there’s no way for companies that aggressively market products before they’ve been tested or that skimp on the scientific studies can’t avoid public attention. For that reason alone, it’s always better to hire a trusted clinical research organization that can give you quality data. Here are some starting points to find a new CRO for your next clinical trial
Always Start with the ICH Guidelines
As always, you’ll want to refer to the ICH’s Guidelines for Good Clinical Practice when you choose a contract research organization. It seems like common sense, but pharmaceutical companies may take a short-sighted view in their desire to complete trials quickly and cheaply. Is the organization aware of the GCP guidelines? Do they allow their sponsors to audit and monitor their clinical research? Do they have the resources to recruit for phase 1 drug trials? These questions should always be on the forefront.
Ethics and PR Go Hand in Hand
Clinical trials are not without controversy. The controversial CAFE study at the University of Minnesota, sponsored by Astra-Zeneca, resulted in the suicide of 26 year old Dan Markingson in 2004. The case is often held up as an example of what not to do in CRO clinical research, but pharmaceutical companies can still receive bad press (and, in some instances, be liable) if they don’t put enough safeguards in place to protect patients. No matter how seemingly trustworthy a CRO may seem, it’s important to ensure that their methods are secure, if for no other reason than to protect yourself from negative public attention.
Consider their Curriculum Vitae
Finally, you’ll want to evaluate your CRO’s track record and credentials. If you’re conducting paid depression studies, ask potential CROs about their experience specifically conducting paid depression studies. With phase I clinical trials especially, experience prior experience with the specific type of trial is a must.
Drug development is risky. Don’t just work with any CRO; be sure you find one that you can trust, even if they don’t produce the results you’re looking for.