A product manager's most critical task is preparing a project plan for a global clinical trial. But what constitutes a successful plan, and how do you execute it in a landscape that has become increasingly more complex? Here's a clue—It's all in the planning

This may seem obvious but, in fact, it is rarely understood: Before defining time, budget, and quality metrics, a comprehensive project plan is required, otherwise objectives will not be realistic.

What's new

Consider first the significant changes in the way studies are conducted:

Regulatory authorities Emerging regions in particular have begun to develop or change existing clinical trial legislation and requirements to ensure patient safety.

Clinical trials logistics Importation requirements and regulations and collection and management of biological samples are different, which makes a detailed plan necessary that covers supplies, storage, and distribution.

Legal aspects Contracts with sites and local regulations and practices need to be negotiated in order to avoid delays in the study's start-up process.

Cultural differences Communication with investigators, patient-physician relationships, and patient recruitment strategies are all seriously impacted by different practices and mores.

Language barriers Principal investigators outside the US are usually fluent in English. However, this is not always the case with sub-investigators, study coordinators, or other clinical site staff.

Investigational sites Identifying the right sites to conduct clinical research is critical. In the near future, support and training will have to be given to newly established sites considering the increasingly large number of competing studies in emerging geographies.

Technology considerations Adoption of new technologies very often varies from country to country. For example, the use of e-patient diaries has had poor reception in some emerging countries due to lack of patient compliance.

Protocol design Frequently, the protocol design dose not take into account either the standard treatment in countries where the study will be performed or product reimbursement issues. Therefore, if the protocol requires patients who originally failed a treatment that is not actually available in the country, it will result in low patient recruitment rates.

Translation requirements A clear understanding of which documents need to be translated and which documents can be used in English is crucial.

Operationalize

One of the main issues when creating a project plan is to design a system where the project team does not have to start from scratch every time there is a new clinical trial.

The framework that facilitates the planning for any project team needs to come down from the very highest levels of the organization to the lowest level (and across all functions) Otherwise, each new clinical trial is like reinventing the wheel, and first studies have to be conducted all over again.

This concept changes the traditional way of planning. To a great extent, it makes the organization responsible for planning (not just the project team).

There are several tools available that can be used for the planning of a clinical trial, but they are useless if the
organization has not structured the knowledge and expertise of its people in a way that can be utilized by the entire organization.