In clinical research, as in many other areas, among consultants and CROs, you will find many people who will do things right for you. We will always strive to do the right thing.
Doing things right in clinical research is extremely important (Good Clinical Practice, control, paperwork, reliability). But doing the right thing is more important. Without the right study question (what do you want to prove? What do you want to claim when your product is on the market?), without the right patient population, without the right comparator, even the best conducted study will lead you nowhere.
Whether it is pilot or pivotal, exploratory or confirmatory, the principal reason for conducting clinical trials is to comply with regulatory requirements and have a product registered or otherwise approved. Here, good relationships with Regulatory Agencies can facilitate an early collaboration and the design of an appropriate clinical plan.
Start-ups need solid clinical evidence to establish their products; Venture Capital firms want to rein in the enthusiasm of the inventor, and find the right study question, the right study hypothesis, the right comparator. Low conceptual and cultural standards in the study protocols written by inventors are common in start-ups, but it is easy for us to improve them and make them acceptable to regulatory authorities and an international medical audience.
For CROs, the design and management of clinical trials is their raison d’être, but they can potentially come across new therapeutic areas where they need external expertise.
Finally, clinical trials are often the only instrument that can be used to obtain the best possible payment for medical products under increasingly stringent reimbursement conditions; or to generate a scientific publication in peer-reviewed, specialised medical journals.