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
Let's start with the basics: The successful execution of a clinical trial means the project is finished on time, on budget,
and has a high level of quality. It only figures then that these objectives should be clearly defined before initiating any
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.
The main purpose of planning is to anticipate all possible actions that will take place throughout the project. The complexity
of today's trials makes such a diagnosis for each aspect of the study (in order to set realistic project objectives) imperative.
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
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
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.
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.