Evidence Generation Moves Closer to Commercial Decision-Making
Evidence generation software has been regarded as a means for conducting clinical trials and organizing study management activities until now. The role of evidence generation software in biopharmaceutical organizations appears to be expanding. As healthcare providers become increasingly reluctant to rely solely on trial evidence, the use of an evidence generation solution could play a key role during the commercial decision-making process.
This situation results from the practical realities of marketing drugs in the current landscape. Regulatory approval of a drug or treatment approach represents only one aspect of its success; however, the actual acceptance requires the collection of evidence about the drug or treatment. Health systems, providers and payers would need additional information related to patients' response rates, adherence and other aspects of therapy in order to decide about using this product in their facilities.
The role of evidence generation software becomes obvious in this case. Such a solution allows the user to create a plan and schedule for collecting evidence and managing evidence generation efforts. Activities that previously were regarded as research support appear to be becoming integral parts of the broader decision making framework within biopharmaceutical companies.
Such changes are reflected in evolving evidence program planning needs. Commercial decision makers need information about the company's evidence strategy since such information could influence reimbursement decisions. Evidence generation software allows the users to see and manage evidence gathering and generation processes in a common framework, thus improving collaboration between departments involved.
In addition, this tool does not necessarily help in eliminating all barriers to efficient collaboration between departments. Researchers and commercial managers have different goals and responsibilities and may interpret evidence needs differently even if they share the same information resources and evidence plans. Moreover, various departments usually operate independently from each other and may have conflicting time lines even if they utilize the same software tools.
Finally, evidence generation involves the collection and analysis of data. The latter factor remains a concern as long as the resulting information must satisfy criteria of reliability and integrity of third party evaluators who consider the product in question. Additional data alone may be useless as part of the company's decision making process. Proper planning is required before launching an evidence generation project, especially when reimbursement decisions and treatment guidelines are expected.
Vendors in this category face challenges associated with changing buyer expectations. Evidence generation software is increasingly evaluated by companies with the aim to establish links between evidence generation activities and decision making processes within the organization.
All these factors lead to reevaluation of the place that this type of solutions occupy in modern biopharmaceutical organizations. Instead of serving the needs of researchers alone, evidence generation software starts to play a major role in supporting commercial planning and other business aspects of a pharmaceutical or biotech organization.
