| Henry Yau at the Clinical Trials Centre, Hong Kong, rethinks the clinical trial agreement management process
Management of clinical trial agreements/contracts (CTAs) for industry-sponsored clinical trials between sponsors and study sites has been deemed a major rate-determining step for the initiation of clinical trials. Study sites are commonly blamed by the industry for their unfamiliarity with legal parlance, incomplete knowledge of legal and regulatory requirements and requests for specific arrangements that deviate from sponsors’ standard contract terms and conditions.
Sponsors, on the other hand, are condemned by study sites for using tricky and difficult-to-understand legal jargon that is biased towards sponsors and unfair to study sites. Within a sponsor's organisation, project teams frequently accuse their legal departments of wasting time on debating meaningless legalese. Legal counsels used to complain to project teams about their overlooking potential legal risks. Such conflicting views among different parties has resulted in fewer industry players attempting to look into the issue from a broader perspective and propose holistic solutions – hence the problem persists.
CTA MANAGEMENT PROCESS
Contracts are normally seen as specifically legal documents. Drafting, negotiating and managing CTAs are, therefore, commonly regarded by many sponsors, contract research organisations (CROs) and study sites as purely legal matters and the sole responsibility of legal counsels. This, however, reflects the incomplete understanding of the functions of contracts. Whilst contracts are intended to be legally binding, the primary purpose of any contract is not to take the contract parties to court, but to set out the rights and responsibilities of those parties and, ultimately, to facilitate the accomplishment of the goals of the parties under the contract. Management of CTAs is a multi-disciplinary process involving four interlocking components (see Figure 1). |
