Development and Execution of In Vivo Bioassays
January 8, 2022
As per Global Data, around 69.9% of global clinical trials since April 2020 suffered disruption due to the suspension of enrolment, whereas 12.8% are due to delayed initiation and 17.3% are due to slow enrolment. Moreover, among the trials affected by slow enrolment, around 15.4% (of the 17.3%) have been due to reduced availability of sites and investigators. Given the situation that the pharmaceuticals sector finds itself in, there are bound to be significant changes in clinical research practices. Some of these trends have been listed below:
1) Virtual Tour of facility for audit purpose
With in-person visits to a CRO office for inspection of facility infrastructure no longer possible due to the pandemic, there is a growing demand for virtual tours of the facility for conducting audits. Once CROs create these virtual tours, even in the post-COVID era, most pharma companies would prefer having virtual tours, since they help in cutting down traveling costs and time.
2) Pharmaceutical Companies to have greater reliance on CROs
There are a couple of factors due to which pharmaceutical companies are bound to have a much greater reliance on CROs in future:
– The complexity of clinical development requirements is constantly increasing, and consequently, the need is increasingly being felt for specialized expertise for taking care of the requirements. This is on account of pharma companies having to address multiple therapeutic areas such as in-orphan diseases, oncology, CNS, diabetes, cardiovascular diseases, and internal medicine. Often, biopharmaceutical companies, especially the smaller ones, do not have the internal infrastructure to conduct studies on their own. The fully loaded costs for every successful molecule have now grown to $2 billion+ on average, and therefore, the importance of therapeutic expertise and scalability to reduce costs and time-to-market for new drugs is being acknowledged across the pharma industry.
– As the science of pharmaceuticals progresses, increasingly complex therapies are being developed with drugs which have advanced modalities. However, this also has resulted in the need to measure a greater number of endpoints, and overcome larger number of regulatory hurdles. As a result, CROs have been attempting to enhance their Pharmacovigilance capabilities so as to be able to conduct increasingly unconventional drug trial designs. A pharmaceutical company might find it commercially unviable to dedicate resources towards developing such capabilities.
3) CROs to be involved beyond mere execution of clinical trials
Traditionally, CROs were mostly be looked at by pharmaceutical companies as agencies to which the execution of clinical trials could be outsourced to. However, with time, CROs have been able to develop specialized core competencies, partly due to working with multiple pharmaceutical clients and partly due to their experience in dealing with regulatory bodies in different geographical locations. As a result, pharma companies are increasingly looking at CROs as strategic developmental partners. CROs can provide vital insights to pharmaceutical companies, both in case of clinical trial failures and successes. In the coming future, after successful execution of clinical trials, pharmaceutical companies are expected to have a growing reliance on the services of CROs for creating the necessary documentation to obtain regulatory clearances. Also, in the event of failure of a clinical trial, the CRO could recommend alterations to a biosimilar drug molecule or modification of the API combination through its experience of conduction clinical trials for previously approved formulations of a similar type with other pharma companies.
4) CROs to develop data capabilities
In the area of clinical trials, there is an increasing reliance on big data and algorithmic approaches to uncover insights, correlations between factors, and hypothesis testing. One aspect where data-driven approaches can prove to be immensely beneficial is while conducting Real World Evidence (RWE) studies, where the economic value of a new drug or therapy can be ascertained. RWE studies are occupying a place of increasing importance in the pharmaceutical industry because developmental and regulatory costs are increasing, and therefore, it is necessary to be reasonably assured of commercial success of a new drug that is sought to be introduced in the market. As such, CROs would strive to develop in-house data analytics capabilities, and pharmaceutical companies would come to rely on CROs to a great extent for commercial advice.
‘Necessity is the mother of invention’ goes an old proverb. The necessity to innovate upon the way clinical research has been traditionally conducted might bring about a complete transformation with regard to trial processes and efficiency. We can confidently say, that in the post-COVID era, clinical research is poised to witness exciting times.
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