Spinos is an industry-leading CRO that conducts bioanalytical/behavioral experiments and provides regulatory support services. BA/BE studies are an integral component of drug development and are vital in expediting generic approval processes.
Prevention trials aim to find effective methods for protecting healthy people against disease while screening trials aim to discover early indicators of diseases or health concerns.
1. Regulatory Agencies
Various regulatory agencies oversee clinical trials of drugs and medical devices. Their mandate is to protect participants from unnecessary or excessive risks while assuring trials follow good clinical practice guidelines. Institutional Review Boards in America are called “IRBs”, while in Europe Ethics committees may serve this function.
Before any trial can begin, all relevant information must be submitted for review by the appropriate regulatory body for approval. In the US this involves filing a Clinical Trial Application with the FDA’s Center for Drug Evaluation and Research while in Europe this could involve filing an MAA with European Medicines Agency (EMA).
At the same time, sponsors must accurately inform all local site investigators of the true historical safety record of any drug, device, or treatment being tested at their clinical trial sites to allow them to make an informed decision regarding whether or not to participate in a clinical trial and any potential interactions between treatment under test and approved treatments that might arise during its conduct.
All the relevant data should be recorded, handled, and stored in an easily accessible format for future reference. A database can help make this easier – also serving to monitor results at each clinical site while verifying compliance with GCPs.
Pharmacokinetics (PK), or pharmacokinetics, is essential in BA BE Studies as it assesses how quickly and to what extent drugs enter and exit the body. Therefore, for valid BE studies to take place, they must follow a randomized cross-over design with wash-out periods at least 5 elimination half-lives long.
2. Increased Productivity
Drug development timelines can be lengthy due to extensive studies of experimental medications that could prove hazardous. This process increases R & D costs while decreasing sales revenue. Technological advances and opportunities for centralized coordination could significantly shorten timelines; however, current clinical trial business models do not take full advantage of efficiency gains (Kramer & Schulman 2011). Patient recruitment also proves costly as many are unwilling to participate in trials.
3. Reduced Costs
Technology advances and opportunities for centralized coordination have the potential to significantly decrease drug development timelines; however, clinical trial business models have failed to fully leverage these efficiency gains. One such example would be using electronic data capture (EDC) more frequently – something which would reduce paper forms and manual queries that are such a burden in BE studies.
Sponsors that utilize EDC will experience lower costs associated with BE studies. When conducting BE clinical trials, PK parameters measured are often log-transformed before statistical analysis, with common or natural logs recommended as per FDA guidance in their protocol and SAP documents. Sponsors should be mindful of any effects this log adjustment might have on statistical results and justify performing analyses on original rather than log scale if they believe this will improve study accuracy or lower costs.
BE clinical trials typically cost less than placebo-controlled studies across most therapeutic areas except gastroenterology, hematology, and immunomodulation due to various factors – including higher costs associated with data collection, administrative staff costs, and site recruitment costs during Phase 2.
4. Increased Marketability
BE/BA clinical trials aim to give stakeholders confidence that a drug will perform as intended when prescribed, by employing a randomized cross-over trial design with five washout periods between each drug administration to ensure blood concentration has dropped below the lower limit of quantification before proceeding with another administration. Furthermore, sponsors must ensure measurements of BE/BA are logarithmically adjusted consistently throughout their study, using either common or natural logs when measuring BE/BA measurements.
Technology advances and opportunities for central coordination can shorten drug development timelines; however, clinical trial business models have yet to take advantage of such efficiency gains and start trials more quickly, increasing costs and decreasing revenues. This results in long timelines for trial launches resulting in additional expenses and lower revenues.
5. Increased Productivity
Spinos has assisted numerous Sponsors in conducting BA BE studies in clinical trials for blood plasma and urine concentration parameters. BE measures often undergo log transformation; to maintain consistency between trials, sponsors should use consistent logarithmic adjustments while clearly outlining either common or natural logs as the basis of each trial protocol and statistical analysis plan (SAP).
Even though technological advancements and opportunities for central coordination hold great promise for shortening drug development timelines, clinical trial business models have yet to fully take advantage of efficiency gains generated from them. This has resulted in extended timelines for drug initiation as well as patient recruitment challenges.