Better integration between research and clinical care can lead to innovative contracting strategies. All stakeholders must be prepped in advance on the challenges they are likely to face
- Gain insight into the perspectives of health care systems and clinical sites
- Hear about feasibility concerns for sites
- Overcome lack of legal expertise and research contract language
- Ensure all stakeholders understand risk tolerance for Partners
The specifications and breadth of patient consent is evolving and has a rippling effect. Hear about how these changes impact clinical trial agreements and how best to accommodate this.
- Examine the broadening secondary use of samples
- Discuss biobanking and explore the complications around patient data
- Understand what is meant by de-identified data and know what your identifiers are according to FDA
For investigator-initiated trials, the regulatory sponsor serves as the principal investigator. This is quite different from an approach where an investigational drug provider would be the PI, so your CTA clauses will have to be re- envisioned for such an approach.
- Understand SAE reporting obligations
- Specify intellectual property and study data ownership and publication rights
- Fully map out the range of liability
- Envision flow downs around subcontracting – expediting review and getting subsites on board
Sponsors, sites, and Academic Medical Centers all have specific responsibilities when it comes to covering patient injuries in clinical trials. All stakeholders must be prepared to clearly and concisely outline their provisions to patients, in a language they can understand.
- Define the patient injury provision in subcontracts and clinical trial agreements
- Discuss the different positions sponsors, AMCs and sites take
- Identify the challenges associated with different positions
- Outline the impact on the patient
Contracts must allow for site monitoring and site review now that COVID has made decentralized trials a reality. Assess plans for updating templates and suggested language.
- Update CTA templates to include contract language providing for remote monitoring
- Address changes needed regarding wording of consent around decentralized trials to meet requirements for subject injury and PHI disclosures and use
- Pinpoint a plan to review records onsite and remotely to fulfill obligations
- Ensure that the way the consent is written in the app fits with requirements for subject injury or phi disclosures and use
- Determine the need for contract language authorizing remote monitoring
International agreements come with their own unique obstacles. By learning from past successes - and failures - you can better position your own future research.
- Internalize what clinical trial agreements look like outside the US – EU, Australia, Canada, Asia-Pac
- Outline the use of CROs globally
- Ensure quality and effective data sharing across continents
- Consistently update and meet compliance standards
Streamlining the overall CTA process from start to finish looks easier than it is. Hear about tips and tricks for negotiation to expedite the contract.
- Identify clinical contracting timeframes
- Actionalize the process for getting sites onboarded and set for payment
- Consider the viewpoints of all parties including sponsors, CROs, and sites
IP clauses are getting broader. Avoid getting caught up in long term negotiations that take longer than they should.
- Implement a process for efficiently assessing and protecting IP
- Review recent developments in the use of samples taken from study subjects when drug is in the subjects systems but not in clinical trials
- Discuss how investigator-initiated trials may require non-exclusive commercialization to product related IP or beyond
Take into account the new NIH regulation and the coming impact on public private research data sharing.
- Understand how data and research are shared and used for additional secondary purpose
- Gauge the impact of this new policy on your CTA
- Determine how this will influence separate side agreements with partnering hospitals
Rising cyber security threats are a cause for concern across the nation and around the world. Hear about the need for cyber-liability insurance and adjustments to the agreement required to manage risk.
- Change contract language around cybersecurity and need for cyberliablity insurance
- Find out what sites are doing about cybersecurity including mandating specific technical requirements
- Consider creating a standard around how to address data liability and cyber risk
Although it’s been around awhile, GDPR still plagues many of us. Gain a very specific interpretation of the points most important for you to know and follow.
- Understand the impact of GDPR and carve outs from GDPR on CTAs
- Address your own GDPR concerns
- Identify the timelines and exact compliance issues regarding CTAs
- Effectively summarize US privacy laws including CCPA