Outsourcing Clinical Trials – Support Functions
To start with, Clinical Trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Now, lets move on with our discussion on outsourcing clinical trials.
Outsourcing Clinical Trials – An Overview
In 2015, 206,949 studies on Clinical Trial Support were registered across the globe. As on July 10, 2016 , 219,712 studies were registered under various sub-divisions such as Interventional, Observational and Expanded access. The bulks of these clinical trials are interventional and are sponsored by academic institutions and private organizations. The sheer number of increase in Clinical Trials every year and increase in research cost is driving the industry to focus on optimization by reducing the cost and high rate of success.The ISR report “2016 CRO Market Size Projections 2015-2020” paints the growing trend for the Clinical Trials Market with an increase in R&D spending up to$303.7 billion. Contract Research Organizations (CROs), specialized in Clinical Research, work with Pharmaceutical, Bio-technology and Medical Devices companies supporting the drug or device development. The CRO’s activities include patient recruitment firms to investigate sites, site management organizations, patient data mining companies and data-capture software vendors. Except for on-site data collection and investigation, all IT and analysis activities in the Clinical Trails can be outsourced. Some of the key challenges of outsourcing clinical trials and outsourcing clinical research, their impact and solutions are discussed in the below passages.
The entire process of a drug from lab to the patient takes approximately 12 to 18 years and an average cost of $359 millions. There can be substantial cumulative savings by offshoring specific functional activities which are repetitive and sequential in nature. In some cases, there could be at least two successful Phase III trials to demonstrate drug safety and efficacy. Outsourcing clinical trials gives the Organization more time to focus their core business process. With outsourcing functional activities, the analysis and reporting tasks can extended to 24 hours a day thereby reducing the overall Trial timeline.
Considering the size and duration of the drug development process, changes in the scope of the project are unavoidable. With regulatory consulting services where the scope of the work is relatively flexible and open ended, a “Time and Material” approach can be adopted. For studies and analysis, the cost can be based on deliverables. The clinical trials outsourcing partner can provide specific skills for the Trial process based on the changes.
Legal and Ethical Aspects in Clinical Trials
There are defined procedures of on-the-ground monitoring services that help in performing many of the Clinical Trials activities that are conducted according to accepted technical standards. It also ensures compliance of national and international ethical guidelines concerning biomedical research in humans.
Understanding Standards and Protocols
The resources involved in the project shall be continuously trained with changing standards and protocols. Internationally accepted standards like GCP and further applicable regulatory process shall be followed. With all these guidelines and training, it shall be feasible to outsource support functions and get similar output from the Offshore teams.
Data Security – Clinical Trials
Many organizations and regulatory agencies concerned about ethics seem to matter currently at the level of the data. In specific, the organizations want to ensure the integrity of data. With the recent changes in security and networking, it shall be possible to manage data security.
Clinical Trials – Cost and Economics
The changes in project scope and deliverables have to be defined and monitored to control the overall cost. Although the overall cost of the deliverable is expected to considerably go down, efficient coordination and clarity in communication pay a key role to meet the overall objective of clinical trials outsourcing.
For the study to be effective, organizations will have to engage experienced and skilled team members for clinical trial support. Beware of high turnover rates as this can quickly lead to damage on the ground. Define metrics and measure regularly.
Considering different variables in the decision making process of Outsourcing Clinical Trial supporting services, clearly there is no one-size-fits-all scenario for meeting the objective. In most of the cases, the companies are looking to outsource only part of the trial deliverables such as SAS Programming, Biostatistics and Data Management. The cross functional teams will have to overcome the differences and work together to ultimately reduce the cost of delivery. With an average increase of 14 % of Clinical Trials every year and decrease in average budget of drug discovery projects, many organizations have started outsourcing some of the clinical trial support services.