All pharmaceutical companies are required to keep key GxP records (eTMF data, clinical study reports, lab notes etc) for the long term. EMA guidelines which came into effect in June 2019 provide a regulatory framework requiring investigators to archive data for at least 25 years after the end of a clinical trial. Some regulations require that data is kept indefinitely. These requirements introduced additional costs and resource burden for trial sponsors – but that’s only half the story.
Proper archival and data management can shift archived data from a regulatory burden, to an strategic asset. There are a number of opportunities to create value from archived TMFs.
Why do sponsors need to access the TMF beyond compliance?
Results from a recent survey of trial sponsors conducted by Arkivum, and published in the report, TMF Futures, Keeping Data Alive, pointed to a range of areas where organizations gain value from properly archiving their TMF, and ensuring that it is readily accessible.
The data shows that sponsors access TMFs:
33% – To support filings of new indications and formulations
28% – For pharmacovigilance
25% – To help with licensing
21% – In the event of legal challenges
16% – For pricing and reimbursement
14% – In the event of due diligence by third-parties in the case of M&A and partnerships
7% – As part of M&A activity
Below, we explore three use cases where TMF data can provide significant value for pharma companies.
Supporting filings for new indication and formulations
Once a drug is approved for the market, pharma companies will continue to look for ways to generate extra value from it.
The 505(b)(2) new drug application (NDA) is one of the U.S. Food and Drug Administration (FDA) drug approval pathways, and is an appealing regulatory strategy for many pharma companies. The filing typically contains full safety and effectiveness reports but allows some information required for approval, such as safety and efficacy information on the active ingredient, to come from existing study data. In the EU, the generic/hybrid medicinal product pathway offers similar opportunities.
The pathways offer a less expensive and faster route to approval compared with a traditional development path for differentiated products that can have incredible commercial value.
Being able to easily access reliable data is essential to these pathways and well-archived, maintained and compliant TMF will be the first step for many pharma companies.
Pricing and reimbursement
The pharma industry knows that drug development is expensive. Pricing and reimbursement is based on a number of factors beyond the cost of drug development and much of this information can be found in TMFs. Three of the key considerations include:
The uniqueness of the drug: The number of other drugs that are already available that treat the same condition will affect pricing. If there are a number of drugs that treat the same condition, new drugs for the same condition will likely be priced lower.
Competition: Sponsors must determine if their drugs have benefits over competing therapies – they’ll often discover this when comparing their drugs to comparators during trials.
Efficacy: Companies must consider whether their drugs can change the current practice of medicine used to treat relevant indications. Therapies that can cut down on expensive surgeries, hospital trips and time spent by physicians have greater value because of the savings they offer insurers, healthcare providers and patients.
Information that contributes to an understanding of these different areas can often be found in TMFs.
The pharma industry is heavily regulated and is at the centre of life-and-death scenarios for patients. The result is that pharma companies often find themselves being blamed when patient and healthcare providers’ expectations aren’t met. Accusations of pharma companies making false claims or hiding side-effects are fairly common and consequent legal proceedings can be costly.
However, data gathered during trials must produce scientifically robust benefit-risk data. Where this correlates with marketing and side-effect claims, pharma companies can use TMF data to help negate liability claims.
While complying with regulatory TMF archival requirements is an essential step for trial sponsors, there is significant value to be extracted from the data – and this value isn’t timebound. Legal challenges can happen decades after a trial closes, new approvals for existing products when innovative delivery systems are developed and pricing and reimbursement must be constantly reevaluated across a drugs’ lifecycle.
Ensuring access to TMFs, and that the integrity of the data therein is well-managed, is an essential strategy for pharma companies beyond compliance.
You can download the full Arkivum report, TMF Futures, Keeping Data Alive, here.
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