In “Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process,” a 2014 book edited by Peter Schueler and Brendan Buckley, experts describe how the pharmaceutical industry is currently operating under a business model that is not sustainable for the future.
As a result, the sector is experiencing a gap between investments in new medicines and the number of new drugs reaching the market, with return on investment under increasing pressure.
“Even though the pharmaceutical industry depends heavily on the discovery of innovative products, it is intensely conservative in the manner in which it conducts clinical trials,” reads the book’s conclusion. “The dramatic manner in which digital photography swept away a giant and long-established film-based industry illustrates how those who stagnate may lose.”
Clinical trials are a key part of evaluating the applicability and performance of new drugs and/or therapeutic strategies, and they are paramount in obtaining the approval of regulatory authorities, such as the Food and Drug Administration (FDA) in the U.S. Typically, these authorities require clinical trials to follow rigorous scientific standards designed to ensure unbiased statistical estimates of the effectiveness of a new treatment on a target group of patients, including safety from unwanted side effects.
Careful selection of patients and procedures for a clinical trial and accurate statistical analysis of the resulting data are of critical importance. Though the regulators are often well intentioned, strict regulatory requirements can make the approval process for a new treatment very long and costly. In fact, the delay and cost introduced by the approval process constitute an important part of the overall time to market and development cost of a new treatment.
The result is that only major pharmaceutical companies can afford to bring new drugs to market and only after careful evaluation of costs against potential benefits. This implies that some new drugs, which could save lives and reduce suffering, might come too late, be priced beyond reach of most patients or could never be introduced at all.
Therefore, it’s important to use modern information technology to streamline the process of developing new drugs and treatments, of which clinical trials are an important part.
Writing for Forbes, Sujay Jadhav, CEO of goBalto, a consulting firm for the global life sciences industry committed to accelerating clinical trials, argued that blockchain technology could soon streamline clinical trials.
“The enormous amounts of data generated in clinical trials, along with trends towards globalization and increasing regulatory constraints, is outstripping the ability of legacy data management platforms to manage the competing needs of data sharing, patient privacy and data integrity,” noted Jadhav, going on to discuss ways in which distributed ledgers could improve patient recruitment, medical data sharing and privacy, data integrity, protocols and the traceability of consent.
For example, blockchains could improve the patient recruitment process by connecting patients with trials anonymously, as described in a recent research paper that shows how distributed ledgers can ensure traceability and allow for securely automated clinical trials through smart contracts. This paper also described how blockchain technology permits securely managed patient consent data, time-stamped for each protocol revision in a clinical trial.
Jadhav concluded that the potential applications of distributed ledger technology to clinical research are wide-ranging and promising, mentioning that IBM partnered with the FDA and the Centers for Disease Control and Prevention (CDC) to pilot healthcare applications that involve both blockchain technology and artificial intelligence, another emerging technology with great potential to streamline healthcare processes.
Last November, IBM Watson Health, the IBM unit in charge of healthcare applications of IBM’s Watson AI system, signed an agreement with the CDC to explore the benefits of distributed ledger technology in the health sector. In January, IBM Watson Health established a partnership with the FDA to define a secure, efficient and scalable exchange of health data using blockchain technology, with an initial focus on oncology-related data. It seems this initiative is poised to approach a restructuring of the clinical trial system as well.
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