By Ed Miseta, Chief Editor, Clinical Leader
Timothy S. Krupa, MS, MBA, is currently president of TSK Clinical Development, LLC, a consulting firm providing leadership guidance and solutions in the clinical development space. Specifically, Krupa consults on clinical planning, clinical project management, clinical operations, and strategic partnering for the biotech and pharmaceutical industries. Tim recently took some time from his consulting practice to share his perceptions on outsourcing and strategic partnering in the clinical space.
Ed Miseta: How will clinical trials of the future (three to five years out) in an outsourced model be different from today and why?
Tim Krupa: As cost pressures continue to rise, Sponsors and CROs will look more and more at effectiveness as a cost measure. Effectiveness will be increasingly looked at as a combination of time, money, and quality in an execution focused environment. Creating strategic partners can lead to long term savings, whereas transactional partnering can only produce a cost savings once. Building a team aligned with the goals that can and will “do it again” will increasingly become the model for strategic partnering. An increasing focus on quality will also drive the creation of truly exceptional teams and this too will be enhanced by working with the same partner “again.”
Miseta: What do you anticipate as being the biggest challenges in executing future clinical trials in an outsourced model and why?
|Timothy S. Krupa, president, TSK Clinical Development, LLC.
Krupa: Trust will remain the biggest challenge to successful strategic partnering and the conduct of clinical trials and this too will drive more strategic partnerships. At the outset of a clinical trial, decisions are rapidly made and remade and many unrelated activities occur all at once. In such an environment, trust is difficult to earn and maintain. Familiarity will be part of the “trust” solution.
From an operational perspective, identifying and recruiting evaluable patients at the predicted rate will remain a challenge. Increasing globalization of clinical trials will continue. Social media will become a tool to identify, enroll, inform and retain patients around the world.
Miseta: How do anticipate overcoming these challenges?
Krupa: Sponsors will take on more of a “Program Leader” position within the strategic partnership; CROs more of the Project Manager role. There will be greater attention to team building, scope of work, and understanding roles and responsibilities at the outset as there is less duplication of functions within the combined Sponsor-CRO team. Sponsors will pay closer attention to their leaders’ overall understanding of the clinical development process and building and leading virtual teams and relying more on their strategic partners to provide the clinical project management. Face to face meetings will increase in frequency. They will be valued for their effectiveness as team building tools that bring about greater execution and quality rather than simply an unnecessary cost.
Miseta: What internal/external roadblocks will prevent companies in the future from successfully executing clinical trial in an outsourced model?
Krupa: Sponsors must develop an internal outsourcing strategy prior to an outsourcing decision and their internal teams must be aligned and committed to the execution of this strategy. Nothing can derail an effective clinical trial launch faster than mixed outsourcing expectations from a Sponsor. CROs must be more transparent in their actions particularly at the outset of the relationship. A Sponsor is placing their future in rhe CROs capable hands. A CRO must clearly demonstrate that trust is merited. More effective face to face kick off meetings that focus on team building, understanding the scope of work and the delivery of written operational plans would make successful partnerships more likely.
Sponsors should judge their potential strategic CRO partners on their ability to produce clean, locked, quality data bases. Every activity prior to the data base lock should be designed to ensure and enhance quality data.
|Timothy S. Krupa, president, TSK Clinical Development, LLC.
Miseta: How would you approach minimizing the impact of these roadblocks on the successful execution of your trials?
Krupa: Sponsors should decide just what type of partner they are seeking prior to extending RFPs. The level of commitment expected from their CRO partner and the actions the Sponsor is willing to undertake to bring this about should be determined and all involved within the Sponsor should be aligned with this vision for the partnership. The Sponsor should ask themselves: Are we seeking the CRO’s hands, their heads or their hearts?
The No. 1 purpose of the kick off meeting should be team building. If an effective team building process cannot be started in a face to face meeting, one never will. The kick off meeting is an opportunity for the Sponsor and the CRO to demonstrate a thorough and common understanding of the scope of work and for the CRO to garner all the information it requires to write effective operational plans, a risk mitigation plan and an effective communications plan that will allow the CRO to make its actions transparent and its commitment real.
Miseta: What do you envision as being the biggest opportunities (e.g. social media) for conducting clinical trials of the future and how should they go about capitalizing?
Krupa: Social media will have its largest impacts with patients. The use of social media will enhance the identification, recruitment, enrollment, and retention of patients. Communication strategies will be developed to attract and inform the patients in ways previously not envisioned. New patient populations will be reached. These informed patients will have a commitment to the trial beyond that which an investigator can obtain. They will be committed to being part of the outcome.
Miseta: How do you think CROs of the future will differ from how they look today and why?
Krupa: Risk based monitoring will have a profound change on how clinical trial data bases are cleaned and locked. Biostatisticians will play an increased role prior to data base lock in examining data trends and identifying outliers. CRAs will need to travel less and their role will morph toward that of site managers. With these changing roles and responsibilities, teams will change and Sponsors should expect costs to be lowered. Clinical monitoring is the single most expensive cost in large global Phase III trials.
Miseta: In your opinion, what are the key CRO attributes companies should be assessing today to successful execute clinical trials of the future?
Krupa: Sponsors should judge their potential strategic CRO partners on their ability to produce clean, locked, quality data bases. Every activity prior to the data base lock should be designed to ensure and enhance quality data. Everything after the data base lock is building the case for the drug. If it is not a quality data base, the registration strategy is at risk.
Sponsors should be assessing their CRO partner’s ability to mitigate risks and CROs should be seeking opportunities to proactively manage that risk. Begin at the Proposal Defense meeting. Sponsors should be ready to make the CRO team think on their feet. Plan A is what will be contracted to run the clinical trial. A succession of Plan Bs is what it will take to conduct the protocol. CROs should come prepared to demonstrate how they will produce a clean, quality data base when they say it is locked.
Miseta: What tools and/or metrics have you found to be the best for effectively assessing these attributes and why?
Krupa: This is difficult to answer in the space provided. Suffice it to say that cleaning a data base needs to commence early, so that corrections can be used to retrain the sites, the CRAs, and the team if necessary. Weekly reports should be generated to assess the timely entry of visit data by the site, the quality of that data, the outstanding issues, and age of those issues. It is further recommended that completed patients be cleaned and their data frozen on an ongoing basis. Patient issues can be identified; these patients taken off the critical path; and, if patient summaries are called for, they may be written as the patient is fresh on the investigator’s mind.
Miseta: In your experience, what lessons have you witnessed being learned the hard way in executing clinical trials in an outsourced model and what advice would you have on ways to avoid?
Krupa: Too frequently, clinical trials end with the Sponsor having a successfully completed trial and with a feeling that perhaps things could have been better. With their next trial, their current CRO partner is given no more consideration than to be one of the CROs asked to bid on the next Request for Proposal. A frequent cause of this is that neither the Sponsor nor the CRO formed and maintained an effective team or the Sponsor is simply following their outsourcing policy and does not believe the CRO performed sufficiently well to seek an exception to the policy.
As the Sponsor, a CRO has conducted the clinical trial. All the knowledge and experience of that clinical trial now resides with the CRO. Sponsor time is often spent “managing” their partner and not internalizing their partner’s relevant experience and learnings. Procedures should be in place to internalize that knowledge and experience in Sponsor personnel.