Conducting clinical research involves a number of components that are highly regulated and often extremely laborious and time consuming for drug companies and outsourcing any part of the process that is not considered "core" is proving more and more popular.
These days contract research organisations (CROs) typically fulfil the role, however, academic medical centers (AMCs), site management organizations (SMOs) and other small players, including independent clinical studies sites, central laboratories and various niche companies, such as electronic technology, packaging and patient recruitment providers are also called upon to help, depending on the task and expertise required.
Such tasks can include anything to do with the carrying out of Phase I-IV studies, from preparing the submission for clinical studies, to patient and investigator recruitment, site management, providing the clinical supplies, conducting the actual studies as well as the data management, analysis of each trial's results and IT support.
The first part of the clinical phase that is outsourced can be very time consuming and involves submitting the application to conduct clinical trials, called clinical trial authorisation (CTA) in Europe and investigational new drug or (IND) in the US.
In addition, an ethics committee or institutional or independent review board (IRB) must approve the protocol for testing as well as the informed consent documents that patients sign before participating in a trial.
Once the go-ahead for a trial is given, sites must be found from where to conduct the trials as well as staff, including physicians and coordinators to run the trial. Site management organizations (SMOs) are often used to manage this service for both drug development companies and CROs.
Patient enrolment is the major headache of a drug trial and consumes more time than any other clinical trial activity, costing the industry millions of dollars. Pressure to speed up clinical trials and reduce the cost of the studies is spurring pharma companies to outsource this function to patient recruitment companies and CROs. Recently a number of Internet-based patient recruitment companies have also surfaced, whose proponents are hailing it as an even more effective recruitment method.
For some drug developers, clinical supply production is a core competency as it is crucial that there are no errors in the clinical supplies that could affect results, however, increasingly the job of manufacturing and packaging the drugs and devices for clinical supply, as well as their distribution, is falling into the hands of contractors.
When it comes to running the actual trials themselves, the expertise required by contractors varies throughout the various phases. Some companies are competent in all phases of studies while many choose to specialise in certain areas.
Phase I trials test a drug for the first time in a small group of healthy human volunteers to determine the drug's activity, such as absorbtion, distribution, metabolism and excretion, including any potential side-effects. They typically take six to nine months.
Phase II studies are done to determine drug efficacy and gain additional safety information of the drug in patients suffering from the condition it is intended to treat. These trials can take from six months up to three years and involve several hundreds of patients.
Most are randomised, placebo-controlled studies and many are also double-blinded, so that the researchers evaluating the drug do not know who is receiving the investigational drug or placebo.
Phase III studies are aimed at further confirming a drug's efficacy and safety and involve hundred to thousands of patients suffering from the condition the drug is intended to treat and can take between 1-4 years to complete.
Once marketing approval is applied for on a drug, all subsequent research is termed postmarketing and takes the form of either Phase IIIB or IV. These studies have the potential to be very large and may range from several months to several years.
Pre-approval Phase IIIB occurs while the product is still in regulatory approval and usually serves to provide extra information to support the drug when it is launched, such as comparative efficacy against competitor drugs.
Post-approval Phase IIIB research investigates the use of a drug outside its approved product indication to explore future new therapeutic opportunities.
Phase IV research, however, investigates products during or after marketing approval in line with their approval labels and are used to address questions about comparative efficacy, tolerability, safety and cost effectiveness of different treatment approaches.
During drug trials, contract clinical trial laboratories are used to manage a range of services including collecting specimens and conducting both routine and specialised lab tests. Their role is important as it is estimated 90 per cent of all data that comprise an NDA are based on these lab results.
Large, central laboratories are now increasingly being used to provide large amounts of clinical trial data into a centralised database in order to save time by keeping everything in one place and eliminating the need to correlate differences in reference ranges and methodologies across local labs.
It is now also becoming increasingly common to see contracts going to companies that provide electronic technology solutions to streamline clinical trial processes.
IT systems, such as electronic data capture (EDC), data management, and biostatistical systems are used to reduce the extensive paperwork associated with clinical trials. Integrated voice response systems (IVRS) are also now popular as a computerised way of tracking drug use, patient assignment, and drug inventory.