Decentralized Clinical Trials may become important where, due the coronavirus pandemic, a patient cannot travel to a study site. In such a case, a Principal Investigator may need to conduct real time virtual chats with that patient using technology. In order to effectuate this, the Sponsor may need to approve purchase an apple IPAD or android device by the trial site or CRO e.g. so the patient can meet with the Principal Investigator through the virtual chats. While it may seem as simple as procuring a digital device at the COSTCO and then arranging for delivery to the Principal Investigator and patient volunteer, in reality things can be far more complex depending on the specific Protocol, disease condition, qualifications of the site and its personnel, privacy laws, state and federal laws governing drug dispensing and delivery and telemedicine, the level of detail in the informed consent form, the current form of CTA that already exists with the Study Site, and other regulatory and legal and operational matters beyond the scope of this article.
What Are Some of the CTA Related Issues?
With regard to the changes to the CTA, one approach would be to use a general CTA clause that acknowledges the need for the remote trial due to a pandemic or similar exigent circumstance and includes some detail but then leaves all other detail to be set out in a formal signed CTA amendment. Another approach would be to try to negotiate and capture as much detail upfront in the main CTA. Each Sponsor needs to make an individual determination here depending on how they negotiate and execute their CTAs.
The CTA Amendment Approach Provides Granularity and Flexibility
The CTA Amendment approach is beneficial because it provides flexibility. Flexibility is necessary with decentralized clinical trials not just because of the evolving nature of the laws, but also because of the changing way the industry and public is accepting new technology in clinical trials. The CTA Amendment approach leaves the deeper thought around the detail concerning new legal clauses that need to be added and also the operational issues around the specific items to be purchased and changes to the budget to a later date. A sponsor can have this template “ready to go” that can be sent to trial sites on a case by case basis as the need arises.
The CTA Amendment approach also allows for granularity and can take into account the unique nature of each Sponsor’s protocol and clinical trial patient population. For example, take the case of a clinical trial site in one state that mostly recruits patients just across state lines for a specific Sponsor’s trial. Some of those patients live in a city where all transportation has been shut down due to an exigent circumstance like COVID-19 and then a number of patients are much more rural, spread out in different small towns in the mountains. The legal thought here, and potentially the actual CTA amendment, will be different than a clinical trial where the clinical trial site and patient population are more localized and without the impact of multi-state legal analysis or delivery of investigational drug product to a remote location.
What are a few Legal and Contractual Issues in the Switch to a Decentralized Clinical Trial
In the case stated above, where the patient volunteers are rural or in the city just across state lines, then legal thought around the impact of state and federal laws around physician licensure, nursing, telehealth/telemedicine and state privacy laws may be necessary, to mention just a few potential legal issues to be considered. In addition, a Sponsor may want to deliver investigational product or other study drug directly to a patient’s home for certain rural patients with limited access to the main dispensing facility. Whether or not any of this delivery (and subsequent drug storage) is legally permitted may require a thorough analysis of law and potentially engaging in additional communications with state or federal drug regulators. Furthermore, new legal agreements may be required depending on who will provide the service (e.g. will Sponsor engage a new vendor to deliver the drug to the patient’s home in the mountains or will the clinical trial site or another entity?).
In addition to state and federal legal issues, contractual issues around intellectual property and data hosting and restrictions on use of third party materials also may come into play. A Sponsor may license data from a vendor, and that vendor may have put restrictions on the use of that data using very specific defined terms. Or in another situation, a Sponsor may use copyrighted third party graphics like a chart as part of its patient or public facing materials. That chart could already the subject of a legal agreement with Sponsor and the copyright holder granting a license to the chart. However, that license could limit the number of copies that can be made or otherwise restrict the manner in which the chart can be copied and distributed. A Sponsor will need to conduct a thorough review of these kind of licenses of proprietary 3rd party data, charts, trademarks, copyrights, images and other materials and intellectual property and consider how the intellectual property will be used, where it will be hosted/stored and who can access the materials. This review will also be Sponsor-specific; with consideration to the specific Protocol and patient population and digital technology to be used etc.
A Case by Case approach to the Clinical Trial Agreement and Amendment
A Sponsor will need to consider the CTA in its entirety because not all CTA’s are alike. Many clauses in a typical CTA may be impacted by a decentralized clinical trial. For example, and without dismissing the importance of taking each clause from the CTA into consideration, look at the clinical trial indemnification clauses. Often, these clauses are tied to formal defined terms and requirements that impact payment to various entities or individuals involved in the newly-decentralized clinical trial. So adopting a new clinical trial structure, which may involve hiring new vendors or performing the trial at different locations or using new technology or data collection procedures, will require an independent analysis because a Sponsor or site may want to capture some of these additional changes in the CTA or CTA Amendment. And these CTA changes could impact many aspects of the Study (from timelines to drug delivery to patient expectations to potentially changing the informed consent form depending on whether that is mandated etc.) so before implementing them, a Sponsor will want to involve all relevant teams in its organization.
This article discusses clinical trial agreement negotiation strategies for Sponsors to consider before moving to decentralized clinical trials, with a focus on effectuating such a change during the COVID-19 pandemic or a similar circumstance. This article discusses some of the issues that a Sponsor may encounter, however it does not attempt to cover or address the impacts of the many laws and regulations (including local, state and federal law and regulations) related to clinical trials or decentralized clinical trials, none of which are addressed here, or what consists of best practice with regard to law or contract negotiation. The article also discusses some reasons a Sponsor may want to consider the CTA Amendment approach, including flexibility and granularity, however, it does not recommend any specific approach.
This article does not constitute legal advice and is not intended to form, and cannot form, an attorney client relationship with LinskLaw or any attorney thereto. LinskLaw has worked with Sponsors, CROs, consultants and vendors in negotiating and drafting CTAs and CTA Amendments for over 20 years. If you are interested in discussing the establishment of a potential attorney-client relationship with the firm, please contact LinskLaw here.
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