Guidelines for Interactions Between CLOVES Syndrome Community and Biopharmaceutical Companies


The interactions between CLOVES Syndrome Community (“CSC”) and biopharmaceutical companies are important and complex. Collaborations between these two stakeholders have become more common in recent years as CLOVES Syndrome Community has evolved and biopharmaceutical industry activity has increased, particularly in rare diseases. 

The principles outlined in the following guidelines are intended to help CLOVES Syndrome Community navigate critically important interactions with biopharmaceutical companies. These guidelines were developed with input from an Independent Expert Panel from the rare disease community with expertise in these collaborations from both the industry and patient advocacy organization point of view. More information on the Independent Expert Panel and the process for developing these Guidelines is provided in the article entitled “Principles for interactions with biopharmaceutical companies: the development of guidelines for patient advocacy organizations in the field of rare diseases,” published in The Orphanet Journal of Rare Diseases, 2018.


CLOVES Syndrome Community seeks the highest level of ethical conduct in engagement with biopharmaceutical companies. The goal of engaging with biopharmaceutical companies is to help enable the development of therapies while maintaining our autonomy. All interactions between CLOVES Syndrome Community, industry and the disease community should be transparent; should enable trust, accountability and shared learning; and ultimately should work most efficiently and effectively toward advancing meaningful treatments for patients. 

There are four main areas of engagement between CLOVES Syndrome Community and biopharmaceutical companies described in the following Guidelines: 

  1. Identification and Engagement with Companies 
  2. Patient Engagement and Patient Privacy
  3. Financial Contributions
  4. Clinical Trial Communication and Support

1. Identification and Engagement with Companies 

CLOVES Syndrome Community desires mutually beneficial dialogue and information exchange with biopharmaceutical companies developing potential therapies for CLOVES syndrome. Dialogue is mutually beneficial when it is aligned with and advances the mission of CLOVES Syndrome Community as well as the biopharmaceutical company.

1.1 CLOVES Syndrome Community proactively seeks contact with biopharmaceutical companies that show interest or activity in drug discovery, preclinical research, or clinical research on CLOVES syndrome. CLOVES Syndrome Community may also contact companies that are not yet working on CLOVES syndrome but have a relevant technology. 

1.2 CLOVES Syndrome Community seeks insights into the objectives and plans of the biopharmaceutical company and the potential therapy being evaluated, as appropriate. In exchange, CLOVES Syndrome Community provides the biopharmaceutical company with community-wide insight and perspective as needed and appropriate to inform the development efforts and strategic decisions of the company. 

1.3 CLOVES Syndrome Community collaborates with biopharmaceutical companies that are conducting ethical, high-quality research in a responsible manner according to industry, national and international regulatory standards. Collaboration can include a wide range of activities such as information exchange, access to disease experts, access to tools and infrastructure (e.g., natural history data and biologic samples), and exchange of resources. 

1.4 CLOVES Syndrome Community strives to collaborate with multiple biopharmaceutical companies to ensure the sustainability of its initiatives and to allow for a diversity of views and therapeutic approaches. 

1.5 CLOVES Syndrome Community discusses goals and expectations of the collaboration at the outset to ensure they are mutual. CLOVES Syndrome Community reserves the right to disengage with a biopharmaceutical company if the goals of the two organizations are not aligned.

1.6. In order to avoid conflicts of interest, CLOVES Syndrome Community does not allow representatives of biopharmaceutical companies actively developing or selling therapies for CLOVES syndrome to sit on the Board of Directors of CLOVES Syndrome Community.

2. Patient Engagement and Patient Privacy 

CLOVES Syndrome Community encourages and enables direct dialogue and information exchange between patients and biopharmaceutical companies developing potential therapies for CLOVES syndrome. The voice of the patient is crucial throughout drug development by promoting disease awareness and sharing patient/caregiver perspectives. CLOVES Syndrome Community ensures the privacy of health data provided to the organization by its membership.

2.1. Any engagement between a biopharmaceutical company and CLOVES Syndrome Community should be done to advance understanding of the disease or research efforts and should have a clearly stated purpose or set of objectives. 

2.2. Direct interactions between specific patients and biopharmaceutical companies are best arranged with the involvement or general awareness of CLOVES Syndrome Community and its Board of Directors. CLOVES Syndrome Community can choose from a range of approaches regarding these interactions, from actively facilitating such dialogues to passively providing training and education for patient community members on best practices.

Including CLOVES Syndrome Community in these dialogues accomplishes the following:

  • Ensures fairness and transparency within the patient community. Information provided by the biopharmaceutical company to one patient is shared with all patients who have a right to that information, and patients outside of the conversation have an equal opportunity to express their opinions to the biopharmaceutical company. 
  • Ensures that the patient community is adequately and well represented to the biopharmaceutical company. The voices of individual patients must be considered in the context of the community as a whole; one patient’s experience may not reflect the experiences of other patients.
  • Helps to avoid misunderstandings in conversations between individual patients and biopharmaceutical companies.
  • Allows the organization to advise patients on the protection of their health and personal privacy in any data collection activities.
  • Allows CLOVES Syndrome Community to better understand the needs and intentions of both the patient and the biopharmaceutical company in order to best move the field forward for the patient community as a whole.

2.3. CLOVES Syndrome Community encourages biopharmaceutical companies to obtain disease insights from group discussion rather than from one-on-one conversation with single individuals. We encourage biopharmaceutical companies to interact with CLOVES Syndrome Community’s Family Advisory Council. Having biopharmaceutical companies interact with patients via our Family Advisory Council will help to ensure that community views are adequately represented and that work is not unduly requested of any one individual. CLOVES Syndrome Community may offer guidelines and training to patients and families on best practices for effective interactions with biopharmaceutical companies. Our Family Advisory Council may from time to time assist CLOVES Syndrome Community in the implementation of these guidelines. In addition to facilitating conversations with our Family Advisory Council, CLOVES Syndrome Community may enable conversations with other patients interested and willing to discuss their experiences to ensure a broad range of experiences are represented.

2.4. CLOVES Syndrome Community expects that learnings and outcomes from all interactions will be shared openly between both parties for mutual benefit. At the outset of these collaborations, CLOVES Syndrome Community may offer the companies guidelines or expectations for how learnings and outcomes can best be shared with CLOVES Syndrome Community.

2.5. “Leaders” (Executive Director, paid staff, members of Board of Directors) of CLOVES Syndrome Community or individuals representing the disease community may be invited by biopharmaceutical companies to speak at internal company meetings, public events hosted by the company or meetings with regulatory agencies. CLOVES Syndrome Community evaluates each invitation and accepts invitations that promote disease education or awareness and elevate the voice of the patient in a manner that is consistent with the points outlined in these Guidelines.

2.6. CLOVES Syndrome Community takes proper steps to protect all personal and confidential patient information both within the organization and when shared with outside entities, in accordance with applicable laws and regulations. CLOVES Syndrome Community undertakes the following: 

  • Assists individual patients in thinking through their decisions about providing information or consent. 
  • Helps patients convey their expectations about privacy.
  • Ensures that biopharmaceutical companies, and other organizations, have in place at least basic guidelines or a policy for ensuring patient privacy prior to any data collection, including surveys, photographs, video and audio recordings, slide decks and consent forms. 

2.7. CLOVES Syndrome Community advises patients and industry that personal health information of patients must not be recorded by the biopharmaceutical company without proper and prior informed consent from the patient.

2.8. CLOVES Syndrome Community advises patients and industry on the value of sharing data with the research community for future research needs and encourages use of consent documents that allow for secondary research on data as permitted by patients. CLOVES Syndrome Community will encourage sharing of data on completion of studies.

3. Financial Contributions 

CLOVES Syndrome Community can be a vital partner to biopharmaceutical companies in the development of potential therapies. Financial resources are a key need for the growth and maintenance of CLOVES Syndrome Community. Demands on the organization are increased by drug development activities, particularly during the clinical and commercial stages. The following principles guide CLOVES Syndrome Community in the receipt of biopharmaceutical company donations:

3.1. CLOVES Syndrome Community requires and maintains proper documentation of all requests for financial support from a biopharmaceutical company. All requests are documented on the letterhead of the organization and clearly state the mission and activities of the advocacy organization and reasons for the request or are submitted via the company’s internal grant system.

3.2. CLOVES Syndrome Community accepts financial contributions that support its stated mission and allow the organization to maintain its autonomy. CLOVES Syndrome Community assesses the alignment of mission between the two organizations as part of the funding discussion. 

3.3. CLOVES Syndrome Community does not accept financial support from biopharmaceutical companies for product promotional activities. CLOVES Syndrome Community avoids taking payment from a biopharmaceutical company that could be perceived as buying special privileges, such as the opportunity to promote a therapy to a patient audience, to direct a meeting agenda, to guide content of educational materials, to promote participation in a specific clinical trial, to influence the outcome of a specific research program, or to provide exclusive support of a particular research program. 

3.4. Financial contribution to CLOVES Syndrome Community be made either as (1) unrestricted funding or (2) sponsorship of a specific activity initiated by CLOVES Syndrome Community to support its stated mission. 3.5. All donations must be given in a named manner (i.e., not given anonymously). CLOVES Syndrome Community is transparent and open about its funding sources. Any funding provided by a biopharmaceutical company is disclosed by the patient organization (e.g., “project supported by…”).

3.6. CLOVES Syndrome Community seeks donations in a fair and transparent manner among multiple partners to avoid real or perceived exclusive relationships and to maintain autonomy. Relying on a single partner and/or industry can compromise sustainability and autonomy; therefore, the organization attempts to receive donations from more than one partner and/or industry whenever possible. 

3.7. CLOVES Syndrome Community may establish metrics to evaluate the effectiveness of an activity or initiative in which it has collaborated with a biopharmaceutical company and regularly communicates back to the company results of the specific project or use of funds. 

3.8. CLOVES Syndrome Community may provide consultation to a biopharmaceutical company if the consultation is consistent with the mission of the organization and allows it to maintain autonomy. Consultation agreements will be approved by the Board of Directors.  Terms of these services will be documented by mutual agreement between the patient organization and the biopharmaceutical company. The Leaders of CLOVES Syndrome Community will not operate as independent consultants to a biopharmaceutical company, without prior disclosure to CSC’s Board of Directors pursuant to CSC’s then current conflicts of interest policies and procedures. 

3.9. The Leaders of the CLOVES Syndrome Community will not accept personal honoraria to speak on behalf of the organization but, alternatively, may have the honoraria given to the organization. 3.10. Reasonable travel expenses incurred to participate in advisory board meetings or disease awareness activities may be reimbursed directly to the individual patient or to CLOVES Syndrome Community.

4. Clinical Trial Communication and Support 

As a representative of the patient community, CLOVES Syndrome Community is committed to providing education and resources about clinical trials to its members. The organization informs the patient community about open and upcoming clinical trials. The organization also educates patients about their vital role during the clinical trial process, from design to conclusion. Overall community participation in clinical trials is essential to advance the science and understanding of the disease.

4.1. CLOVES Syndrome Community acts as a conduit for information about clinical trials by providing education and resources to the patient community.

4.2. The choice to participate in any particular trial is an individual one; CLOVES Syndrome Community does not seek to influence that choice, but rather, assists patients and families in making informed decisions through education and awareness.

4.3. CLOVES Syndrome Community disseminates accurate and fair-balanced information about clinical trials without adding commentary or opinion that may influence an individual’s decision in any way. 

4.4. To support optimal clinical trial design and communication, CLOVES Syndrome Community may provide the biopharmaceutical company with community-wide observations, needs and barriers to participation. 

4.5. CLOVES Syndrome Community shall develop and communicate a position on their role in the sharing of individual clinical trial experiences in social media. Disclosing clinical trial experiences in social media can compromise the validity and conduct of a clinical trial and has implications for individual health privacy. However, ultimately, the choice to share information is personal; thus, a patient organization cannot dictate what information clinical trial participants do or do not share in public forums. The patient organization may provide the community with educational materials on the potential implications, both positive and negative, of disclosing clinical trial experiences publicly. 

4.6. Board and committee members of CLOVES Syndrome Community have a responsibility to represent the patient organization in their conduct. Information about clinical trials that is accessible to the community through social media, including in personal blogs or other forms of communication, should adhere to the principles outlined in these Guidelines. 

4.7 At the end of a clinical trial, CLOVES Syndrome Community asks the biopharmaceutical company to provide a summary of available trial results for trial participants and the patient community in a timely fashion. CLOVES Syndrome Community requests that the company inform patients, in a way that is easily understandable and offers the option to seek clarification, about the ways in which the patients’ participation has resulted in a valuable contribution to the knowledge base or to the development of a therapy.

Training, Review and Improvement Process

CLOVES Syndrome Community will provide internal training and education to our Board, volunteers and staff on these guidelines and will conduct periodic reviews of interactions with biopharmaceutical companies in order to ensure conformity. From time to time, situations may arise that are not specifically addressed by these guidelines, and in such situations CLOVES Syndrome Community will assess those situations and make policy determinations on a case-by-case basis by utilizing these guidelines as a reference and ensuring that all decisions are consistent with the spirit and intent of the principles outlined in these guidelines. 

CLOVES Syndrome Community will continually seek opportunities to improve on the content and clarity of these guidelines through a review of these guidelines not less than annually.


Stein, S., Bogard, E., Boice, N. et al. Principles for interactions with biopharmaceutical companies: the development of guidelines for patient advocacy organizations in the field of rare diseases. Orphanet J Rare Dis13, 18 (2018).

Approved 6/14/20