Advancements in medical research have been critically important for the improvement of healthcare. They have helped progress in prevention, care, and treatment of people living with diseases. This progress could not have been made without the participation of not only physicians and patients, but patient advocates and support organizations as well.
However, running a clinical trial study is an arduous and complicated task.
Many issues still plague the clinical research industry such as low patient participation in clinical trials, patient diversity, patient burdens and consent forms. An increasingly important challenge is being created as organizations conducting trials use multiple disconnected methods to manage them. The data generated from these methods is stored in a proliferation of disparate data silos that have limited collaboration, making it difficult to do cross-query. In turn, this can lead to the creation of disconnected reports, which cannot provide a comprehensive view of the trials. Although organizations are data-rich, the current scenario of dispersed data silos causes immature information consumption. So, it becomes difficult to monitor clinical trials and proactively address quality issues.
There are many advocates for securing mutual pharma partnerships in clinical trials, but for the most part, have been greatly opposed to such collaboration. It is easy to see why in terms of the ethics and economics of drug development. The list of challenges is almost endless, including tricky practices for extending drug patents, the role of generics in spurring innovation, the tendency for pharmaceutical companies to buy up smaller companies, the pressure on the drug industry to lower prices, whether marketing budgets play a role in the cost of a drug, how legislation to restrict conflicts of interest is impacting innovation, and what really goes on at regulatory agencies.
However, what if healthcare stakeholders all got together and said: “We all want what’s best for the patients. So, let’s figure out a way to test drugs in a single study to figure out which drug is best for which situation quickly and efficiently, without wasting time and money?”
One innovative shift that the pharma industry could take is creating closer collaborations with other parts of the clinical trials industry such as healthcare startups, health entrepreneurs, comparator manufacturers and vendors, and digital technology companies. Collaborative networks can allow member companies to procure drugs directly from each other for their clinical trials. This can potentially help provide companies with an adequate and timely supply of comparator products, thereby, reducing the challenges associated with sourcing.
In addition, collaboration allows information to be shared between sponsors and manufacturers about which companies need which product and how much of the product is required. All this can enable accelerated trial timelines, which can, in turn, increase patient safety. It can also promote the development of new drugs that can be used to treat seriously sick patients. It is clear, therefore, that collaboration can do good for the whole healthcare system, not just the developer of a new drug.
Adopting digital technology to enable collaboration
One of the keys to successful clinical trials is transparency, seamless access and management of data at all levels. This must be assisted by effective, collaborative workflows to mitigate identified risks. To do so, industry needs to be more proactive in adopting digital technology to enable collaboration.
Clinically led improvement, enabled by digital health technology, is transforming the delivery of clinical trial management and healthcare practice. However, there is an agreement around the world that healthcare is at least a decade behind other industries in the use of digital technology. It may be even further behind in realizing the productivity and value improvements that have been seen elsewhere as the result of digital technology. Strategic decisions about clinical transformation and the associated investment in information and tech can be slow. This needs to change.
Collaborative clinical trials would likely require changes in FDA and EMEA review requirements, extremely careful management of conflicts of interest and any incentives that could bias the study toward one drug or another. It would somehow need to avoid getting bogged down by the predictable mountain of legal documents that everyone would require for confidentiality and patent protection.
Nonetheless, progressive healthcare companies that embrace start-up partnerships and integration will be better equipped to address healthcare trends in an increasingly complex environment.
Sarah Iqbal is a research scientist with a background in biopharmaceuticals and business entrepreneurship. She is currently the Head of Digital Life Sciences at Biotaware Ltd, a connected health company with expertise in mobile app design and development, wearables integration and cloud server tech in clinical trials and consumer well-being industry.